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Engineering Manual PCS 7

1. L lt Press Al for help ag KE Event Tree Default Iw Display symbols for modification status i OK Cancel Help The color display setting can be customized Saving or printing differences between projects The differences between projects detected by the comparison can be saved in a csv file or printed out The following information is displayed e Additional objects contained in project A e Additional objects contained in project B e Differences between project A and project B Application examples for the VXM Case 1 The Version Cross Manager can be used to verify that a change has been implemented correctly in the context of the change control system for example By comparing the software version before the change with the current program version in the CPU of the automation system the changes in the system are identified These changes must match the specified changes SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 123 Support during Verification Case 2 Another use of the Version Cross Manager is for verifying that an archived software version matches the current program version in the automation system s CPU In the absence of an application for a change a comparison of the current software backup with the automation system must not reveal any deviations between the software backup and the CPU of the automation system See chapter 8 27 hange Control during Operation for
2. The graphic shows an example of a solution for lifebeat monitoring with a third party system SIMATIC PCS 7 sets a defined OPC variable bit from logic 0 to 1 After a defined period of time X the connected system must reset the OPC variable bit from logic 1 to 0 This operation is repeated in cycles If the connected system does not perform a state transition within the specified time a process control message is generated in the SIMATIC PCS 7 process control system This message indicates to the operator that communication with the connected system is not functioning cor rectly Audit Trail and Change Control Traceability of operator intervention and critical parameters and data changes must be recorded with information about the operator audit trail The requirements of this topic are defined by 21CFR11 of the US Food and Drug Administration for example In a controlled environment changes to the project configuration or user manage ment for example are subject to change control This change control is supported by recording log files Ina PCS 7 system this is implemented by a multilayered approach to the topics of audit trail and change control SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 Creating Application Software OS Audit Trail Change Log BATCH Audit Trail Change Log ES Audit Trail Change Log E Download to CPU mM Project access E Batch control M Recipe administration
3. el Referenced OS station J WinCC Applikation Cien d Path to the OS target computer a DC d WCLIENT2 0SC 2 _Rel 1 mep BR ClientiRef S J WinCC Appl Client Ry S OSC 2 pe Broin O5 Basis J WinCC Applikation eo Se EA 05 1 Reference Basis OS Note If the reference station is changed all OS stations which point to it must be loaded Advantages of using referenced stations Referenced stations help to minimize errors and the amount of work required The reference station only has to be thoroughly tested in accordance with its specifica tion Only special configuration features need to be taken into account for refer enced stations for example screen resolutions PCS 7 client specific operating ranges and user rights General function tests also need to be performed 9 3 Using the Master Data Library To allow several instances of the same functions to be generated SIMATIC PCS 7 offers a duplication option based on a defined software procedure However this is only possible in conjunction with the master data library which contains not only the folders for process tag types and models but also the folders for shared declarations units enumerations and equipment properties The project typicals are created on the basis of the libraries used PCS 7 standard library Advanced Process Library APL etc They are then stored and managed SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 47
4. User Specific Blocks and Scripts User specific blocks FB FC and scripts C VB are programs written and created by the user which are assigned to GAMP software category 5 see chapter 7 3 1 Software categorization according to GAMP Guide for more on this This type of software was developed to meet customer specific demands not covered by existing functions and libraries Note The creation of category 5 software should be avoided if possible because it significantly increases the testing and validation work required The procedure for creating GAMP category 5 software is as follows Creation of a functional description for the software Specification of the function blocks used Specification of the inputs and outputs used Specification of the operator control and monitoring capability Creation of software following specifications and programming guidelines Testing of the structure for compliance with programming guidelines Testing of the function for compliance with the functional description Approval prior to use and or duplication Gen et fg SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 73 Creating Application Software 6 5 6 5 1 74 When creating user specific blocks and scripts the rules for the creation of software elements should be defined in instructions specific to the pro ject department SOP coding standards PCS 7 style guide etc See also e Manual PCS 7 V7 0 Programming Instruc
5. Color Font Archive Versioning Used Plug in Modules Report Electronic signatures Action Roles Sequence TT Release library For production Cl Release library For testing TT Revoke release of library Release master recipe For production Release master recipe For testing CT Revoke release of master recipe Cl Release Formula TT Revoke release of Formula co Oo CH Za bi CO OH Force comment when signing Edit Default Cancel Help A comment can also be entered for each electronic signature this comment can be forced in the mask shown above In addition to these global project rules object specific rules can also be created for electronic signatures The figure below shows some example signature rules for a recipe The settings are made in the recipe properties SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 93 Creating Application Software SIMATIC BATCH Recipe Editor Dryer 1 0 Recipe Edit Insert View Options Window Help Ea Dryer 1 0 Dryer e See x e General CH Instruction eq Input material ay Output material 8 Parameters ie Transfer parameter ESI Fi I Jh Activate g E E Dry Se eee ee Analysis configured roles CS Operator g Shift manager Cancel Help Drain The electronic signatures created are stored in the SIMATIC BATCH change log Properties of Workshop He E EH General E Allocations f
6. See also e Manual PCS 7 Compendium Part A chapter 2 6 Creating the plant hierarchy SIMATIC PCS7 V7 1 GMP Engineering Manual 50 A5E02795571 01 Project Settings and Definitions ES TUWV7_MP Plant View D GG TUWV7_MP TUWV_MP Si TUWV7_MP gy GENERAL BREAC ER TUW Pi J Shared Declarations di E C Cut ED zt HA Gelies EE EE Insert New Object Ep TUWA dn TUW Access Protection Print Plant Hierarchy Settings Process Tags Models Check Consistency Open Check Lag SIMATIC Route Control Create Update Block Icons SIMATIC BATCH Open Block Icons Log Rename F2 Change AS Assignment Object Properties Alt Return Change OS Assignment Cancel Assignment Create Update Diagnostic Screen Display Diagnostic Screens Log Update in the Multiproject Clear Shortcut Note The template project takes on a kind of master role in other words the names of the created hierarchy folders can only be changed centrally in the template Names can only be changed in the replicas once this connection has been removed 5 4 SIMATIC NET 5 4 1 Configuring SIMATIC NET SIMATIC NET reflects the gateways used in the project The SIMATIC NET network addresses and settings for the AS OS distributed I O etc described in the specification must be used for configuration This is verified later during testing for example FAT IQ The gateways are con
7. Simple batch processes and continual processes are automated with the tools for CFC SFC and SFC types configurable sequential control systems provided in the PCS 7 Engineering System SIMATIC BATCH is used in more demanding systems with recipe procedures SIMATIC BATCH is used to graphically design plan modified control and moni tored recipe structures A major advantage of the batch production is the collection and archiving of production data These production data are needed for both the regulatory requirements for traceability audit trail as well as for operational analysis of the production process Batch definition of terms Some commonly used BATCH terminology is described below Master recipe Set of rules and information required to define how a product is manufactured Control Copy of the master recipe with extra information specific to a process cell recipe Batch Equipment dependent amount of a product manufactured in a defined discontinuous production sequence Procedure A sequence of chemical physical or biological activities for manufacturing materials or products SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 Creating Application Software 6 6 2 Conformity with the ISA 88 01 standard ISA 88 also known as S88 is an international standard for batch control which represents the design specifications for software equipment and operation of the processing SIMATIC BATCH was developed on
8. Each block instance can also be assigned a picture icon which can then be automatically inserted along with its tag interface into the flow chart defined in the SIMATIC Manager by deriving it from the screen hierarchy during OS compilation This saves work and ensures that the picture icon is connected to the correct block instance Models can contain pictures and reports Note see chapter 6 1 3 Automatic generation of block icons for information on using block icons These faceplates should be tested together with the associated software module as a process tag type and approved by the customer before they are duplicated SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 Creating Application Software 6 1 2 Example of a process tag type Every software module is created as a template in the form of a CFC chart Following a software module test this is released for instantiation and can be used within the framework of the configuration For a spring closing valve the module might appear as shown below OUTPUT CH_DO aaa Digital 16 8001FFFE Dec The feedback signals must be connected to the VALUE input of the blocks FER OPEN and FER CLSD The control output for the valve must be connected to the VALUE output of the OUTPUT block The valve to be controlled features a control signal for the OPEN function and two feedback messages for the states opened and closed as well as monitoring of module UO faults for
9. Lengths Local Data DU bytes BATCHY70 Object name G E EM_TEMPLATES AG EF Size Author Default U H Shared Declarations MCF 2 bytes 2 mg Process_Cell o Uniti Load Memory Requirement 88 bytes ei EI EMDI Work Memory Requirement 38 bytes ei EMO2 zz En ra Pa Demo AS 7 DE is write protected in the PLC I Standard block I Know how protection I Unlinked IT Non Retain I Block read only PCS 7 supports the option for semi automatic versioning of CFC SFC charts and SFC types This versioning must be enabled in the properties of the particular project or multiproject Properties Project E General Required Software Packages Mame Storage Location le projekte asi Vas zdp Type STEP Project Use Pcs H D Project Language Deutsch Deutschland IT Can be opened under any Windows language settings language neutral I Set project language to Deutsch Deutschland IY Chart versioning Author Date Created 08r 2009 09 28 05 4M Last Modified 0873172009 09 29 00 4M Cornment Cancel Help When the versioning for the respective project is enabled a dialog box opens automatically when you close a modified CFC SFC chart or SFC type In the example below this is the Properties CFC Chart dialog Properties CFC chart Ea General Version Verziopt E es es BEE l Data version wr SIMATIC PCS7 V7 1 GMP Engineering Manual A5E027955
10. O Automation in PCS 7V6 0 0 E Branche3 5 i E EI Branched M O Automation E IN S E Branches M T E Automation E DI v z tomation 0 1 Gl Branches z eer D P fl Branche7 E Find replace 01 Ga Buffer e Cadi ei gt m 3 VALVE 1 Find what Replace with 7V60 10 1 ondensator ergeet Overview MOT_SPEED 1 1 ii 0 3 D D 01 Gest t Premixer Search range ei P301 Current column Current row C All Selection e ei P302 elen Match case I Find whole words only JE Reactor E Silo E IEN Tankfarm Find Replace Replace all cose Help E Test E fr Picture 2 SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 63 Project Settings and Definitions Versioning the Hardware Configuration in HW Config e HW Config SIMATIC 400 Configuration EM_TEMPLATES aly Station Edit Insert PLC wiew Options Window Help ECHTER Properties PS 405 204 RO S1 2 PS 405 204 General 4 CPU 417 4 Short Description PS 405 204 Power supply 24 VDC 20 A I oe H UDP H Order No BES 405 0RA01 0440 Name Comment Author Max Mustermann Version 1 0 Startup a Cancel Help a 0 UR2 Slot 18 Module Oo Fi M 1 0 Comment 1 F PS 405 204 DEG Author Max Mustermann Version 1 0 Startup In the Properties mask the comment field can be used to enter the version ID and additional i
11. 1 00 Workshop user Beim Restore Process cell Process cell data activated by server Production 2008 01 30 12 29 13 UTC 1 00 Workshop user Process cell SB6_2 82 434427 Process cell Process cell data activated by server Production 2008 01 30 14 42 30 UTC 1 00 Workshop user Process cell SB6_2 82 434427 Process cell Process cell data activated by server Production 2008 01 30 15 00 08 UTC 1 00 Workshop user Process cell SB6_2 82 434427 Process cell Process cell data activated by server Production 2008 01 30 15 02 01 UTC 1 00 Workshop user Process cell SB6_2 82 434427 Process cell Process cell data activated by server Production 2008 01 30 15 14 58 UTC 1 00 Workshop user Process cell SB6_2 82 434427 Master recipe deleted Workshop 2008 01 30 16 07 06 UTC 1 00 Workshop user 1 0 Materials deleted RM_O01 2008 01 30 16 07 42 UTC 1 00 Workshop user RM_OO1 Materials deleted H20 2008 01 30 16 07 49 UTC 1 00 Workshop user H20 Batch deleted Charge 2008 01 30 16 15 36 UTC 1 00 Workshop user Batch deleted Charge 2008 01 30 16 15 38 UTC 1 00 Workshop user Batch deleted Charge2 2008 01 30 16 15 40 UTC 1 00 Workshop user Batch deleted Charge3 2008 01 30 16 15 42 UTC 1 00 Workshop user Comment for a single log entry Process cell data activated by server Variant 13 Map time point 11 22 42 1 30 2008 UTC 6 10 Configuration for Electronic Signatures If electronic signatures ar
12. The relevant national regulations must be observed when configuring commissioning and operating fail safe systems S7 F systems provide a refer ence sum of the fail safe program section available This sum is recorded to enable the detection of changes in the fail safe program See also e Manual PCS 7 PC Configuration and Authorization Hardware specification The Hardware Design Specification acronym HDS describes the hardware architecture and configuration The HDS should for example define the points listed below This specification is used later as a test basis for the IQ and OQ e Hardware overview diagram e Network structure e PC components for server and client e Automation system with CPUs I O cards etc e Field devices The HDS can be formulated as part of the Functional Specification or in a separate document Note The information in the hardware overview diagram and the naming of hardware components must be unequivocal See also e GAMP5 Guide Appendix D3 Configuration and Design SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 3 2 System Specification Hardware solutions for special automation tasks Additional device specific solutions are required to integrate hardware components which are not offered in the SIMATIC hardware manager These components are interfaced using special device master data GSD Integration examples for such hardware components include e Integration of wei
13. backed up amp disconnected The transfer procedure may depend either on particular time periods or on the amount of free hard disk capacity available It must be set up accordingly taking the availability of data for online display connected status into account SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 105 Creating Application Software Backing up configuration data 6 13 106 StoragePlus maintains a table of contents of all database files which have been created without which archived data could not be accessed This table of contents along with the created views and other system settings is needed in order to restore the system and must therefore be stored using the Configuration Data gt Save button Recommendation This configuration data must be saved regularly for example each time archive data is transferred See also e Manual PCS 7 Compendium Part A chapter 7 4 6 StoragePlus Uninterruptible Power Supply UPS UPS systems are necessary so that process and audit trail data for example can continue to be recorded during power failures The design of the UPS must be agreed with the system user and specified accordingly The following items must be noted here e Energy consumption of systems to be supplied e Performance capability of the UPS e Desired duration of the UPS buffering The energy consumption of the systems to be buffered determines the size of the UPS A further se
14. bigger project changes also periodically e g once a year e Periodical backup copy of all archived data to assure readability of data and media e g once every 3 5 years See also Chapter B 17 Data Backup Chapter 8 4 System Recover Change Control during Operation It is essential that all changes to be made to validated plants are planned in consultation with the plant operator documented and only executed and tested once they have been released A change procedure used for change control during operation would include the steps below using the example of a software change e Initiate and describe the change which is released by operator e Verify the current software using the Version Cross Manager and an online comparison e Adapt the system specification in the FS for example e Perform and document the change e Verify the changes using the Version Cross Manager and an online compari son e Test the change and create appropriate test documentation Remote Maintenance As of PCS 7 V7 0 Microsoft NetMeeting is the recommended tool for performing remote access It forms part of the operating system and does not have to be additionally installed Essentially a connection to an external PC station can be established via a modem ISDN xDSL or a network To dial in to an external PC station not only must the user have the appropriate access permission user name and password but the Allow remote access
15. 1 GMP Engineering Manual A5E02795571 01 2 3 2 4 Requirements of Computer Systems in a GMP Environment Project Change and Configuration Management All the controlled elements of a system should be identified by name and version and any changes made to them should be checked The transition to the opera tional procedure should be decided in good time The procedure includes for example e Identification of the elements affected e Identification of the elements by name and version number e Change control e Control of the configuration storage release etc e Periodic checks of the configuration See also e GAMP5 Guide Appendix M8 Project Change and Configuration Management Software Creation Certain guidelines must be followed during software creation and documented in the quality and project plan GEP idea Guidelines for software creation can be found in the GAMP Guide and other relevant standards and recommendations Using typicals for programming While the validation of standard software only calls for the software name and version to be checked customized software validation requires the entire range of functions to be checked and a supplier audit to be performed To keep the required level of validation work as low as possible priority must be given to standardized function blocks products in house standards project standards during configuration Standard function blocks are used to create and test c
16. 2 Bulk Engineering with the IEA Version Trail SIMATIC PCS 7 Version Trail enables multiprojects single projects and project specific libraries to be backed up together with the assignment of unique version ID for the archived projects For more information on the configuration and use of Version Trail see chapter 7 4 1 ersioning Projects with Version Trail Version Cross Manager The Version Cross Manager is an add on package for PCS 7 which allows two PCS 7 user projects or libraries to be compared and any differences to be dis played Multiprojects cannot be compared For more information on the configuration and use of the VXM see chapter 7 4 2 Version comparison with Version Cross Manager VXM Route Control The SIMATIC Route Control add on package is used to configure monitor and diagnose materials handling paths within a plant It is fully integrated in SIMATIC PCS 7 and SIMATIC BATCH For more information on the configuration and use of SIMATIC Route Control see chapter 6 7 IMATIC Route Control Simulation with S7 PLCSIM S7 PLCSIM is a simulation tool for S7 user programs This software component which is available as an option simulates a SIMATIC S7 CPU on a programming device or PC The configured application software can be tested without the use of AS hardware CPU and or signal modules Only one CPU can be simulated at a given time Communications processors and Route Control cannot
17. 2 10 2010 Product SetCommonDir gt done Product SetCommonDir Product SIMATIC MS Update gt Done Product SIMATIC MS Update Product Siemens Automation License Manager Shared Component MST gt done Shared Component autacc Shared Component MST d Version V1 0 SP1 Version 1 0 2 10 2010 07 13 01 Release VO01 00 01 00 01 02 00 01 Version V1 0 SP1 02 10 2010 07 24 19 Version V4 0 SPS autacc Release KO3 00 01 00 01 02 00 02 Release KO3 00 01 00 01 02 00 02 LLAITF Release KO4 00 01 00 01 01 00 01 Version Version Version 02 10 2010 07 24 Release KO4 00 05 00 01 06 00 01 3 0 2 10 2010 0 2 10 2010 07 25 4 0 2 10 2010 0 2 10 2010 07 25 gt done Shared Component LLAITF Release KO4 00 01 00 01 01 00 01 Version gt Done Product Siemens Automation License Manager Version V4 0 SP5 02 10 2010 07 25 52 Product SIMATIC STEP 7 Version V5 4 SPS Release K5 4 5 0 12 6 0 1 Deinst LLAITF Version 4 0 2 10 2010 07 27 50 gt done Deinst LLAITF 2 10 2010 O07 27 51 Shared Component MST S 7DOS Release VO6 01 00 00 01 15 00 01 Version 6 1 2 10 2010 07 gt done Shared Component S7DOS Release VO6 01 00 00 01 15 00 01 Version 6 1 2 10 2010 07 31 08 Shared Component MST SNETSNPB Release VO 01 02 00 35 95 00 02 Version 7 1 2 2 10 20 2 10 2010 07 F b INF 4 02 10 2010 07 27 39 gt done Shared Component SNETSNPB Re
18. E Operator entries E System messages SIMATIC Logon Audit Trail Change Log Recording events e g logon logoff Auto logoff Password and change dialog Logon device e g keyboard smart card reader Interface to 3rd party and project specific applications 6 9 1 PCS 7 ES Audit Trail on PCS 7 ES Typically configuration data which is not directly subject to the extremely strict requirements of 21 CFR Part 11 is dealt with on the engineering level Having said that the system components concerned are usually critical ones which must be validated and controlled The traceable online parameter change feature also enables certain quality related data to be accessed directly via the ES However it is often practical and a customer requirement for such interventions to only be performed on the operator control level and if the corresponding operator permission is available with changes being logged in the central OS audit trail Note Parameter changes made on the OS interface are not automatically transferred to the offline project To do this the relevant parameters must be selected and the Read back parameters function executed Depending on the customer controlled online parameter changes made via the ES during the commissioning phase may sometimes be accepted or even desired However once a plant has been validated such parameter changes must only be made via the OS level or on the ES by means of a change re
19. Equipment properties Shared declarations H Plant i Filter by column Display Filter general Globales Schiiftfeld Block 3 ETAL SE Documentation Color_Lib Block comm I O name 1 0 comment Pr 0S__ Archive name Tagname It Longen a Tag supply Archiving Acquisition Factor for ar_ Archiving 1 PID Control PV_IN Process Wal AD044209 D RL TC REACT TC e ystem Ge 500 ms 500 ms dee Control LMNF_IN Feedb of M AD044289 CTRL_TC311 TREACT TC System Released 500 ms i 500 ms PID Control SP Active Sein AD044289 CTRL_TC3T1 REAC1 TC a Kl System Released 500 ms 1 500 ms 4 PID Control PV IN Process Wal AD044289 FC117 DMTLEO System Released 500 ms q 500 ms 5 Ip God LMNR_IN Feedb of M ADO44289 FC111 BMIIED System Released 500 ms N 500 ms PID Control SP Active Sein AD044289 FOI ColorRMT1 System Released 500 ms 1 500 ms 7 PID Control SP Bette Sep AD044289 FCI DMIILEO System Released 500 ms 1 500 ms The specification documents process tag list functional specification etc contain definitions for the following process value archive parameters for example e Classification of messages which have a bearing on quality and those which do not e Type of acquisition cyclic cyclic continuous upon change etc e Cycle time e Type of value instantaneous value mean value maximum value
20. In SIMATIC PCS 7 the default time transmitted on the buses is always the standardized world time UTC Universal Time Coordinated The time stamps are generated in UTC and stored in the archive of the OS server In runtime all the process data stored in the archive messages and trends are displayed converted from UTC to the time zone set in the Windows system taking the daylight saving standard time setting into account Activating time synchronization in PCS 7 means that an active time master handles the synchronization of all OS servers operator stations automation stations and the engineering station To ensure synchronized time all the stations in the PCS 7 system must be synchronized so that messages can be processed in the correct SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 57 Project Settings and Definitions chronological order throughout the plant archiving of trends messages redun dancy synchronization of servers Time synchronization in a Windows work group In a workgroup environment the plant bus is synchronized via the central plant clock SICLOCK for example The OS servers obtain the time from the plant bus they are configured as cooperative time masters If no SICLOCK timer is avail able an OS server becomes the active time master The automation stations obtain the time from SICLOCK they are configured as time slaves The OS clients obtain the time from an OS server they only receive t
21. List Regulations guidelines n0nnnnennnnennneeennnn 11 Remote mamtenance 128 Retrieving data 19 87 130 ROP IDTV eae T 27 ROWE eege E 25 82 S ST TER 25 ee Fa A 01 EE 44 Eeer 73 SEELEN egener eege 23 Sequential Function Chart 24 26 50 60 124 Service PACK teen Eege ee Eege EN EE 24 26 50 60 124 SEC VO Oier E E 68 SFC Visualtzaton 26 SICLOCK saora eaten 58 SIMATIC BATCH 27 41 76 79 92 99 105 SIMATIC Logon 24 35 74 92 SIMATIC NET eifreg AG eged 51 SIMATIC POM wettest etcetera ng ai 54 SIMATIC Route Control 25 SIMATIC Security Control 44 SIMATIC Version Cross Manager 25 el IEN 118 Software category cccceceeeeeeeeees 14 73 112 Software modules eonnenneenenrrsnrsnnrrrrerrerrnn 67 Software Specification cccceecessecceeeeeeeeees 23 Software update 131 lge ler le EE 21 SIOLAGS EE 28 103 SUPDUST AUG EE 20 System recovery cccceeecccseseecceeeeeseeeeeeseees 129 134 T Third party Compopnente 20 Time swvpchrontzaton 20 57 Kieler nunaa a ae a 15 67 U UP eea e On NOS Ce ee eI oe eo 106 SOUND EE 16 User management 16 24 31 User poermiseions 36 V Validation manual 12 VENCAU WEE EE 109 Application Software ccccseeeeeeeeeeeees 117 etzlee HE 110 SOM WANG EE 112 Software pDrocduct nena tn 114 Version Cross Manager 25 88 122 Version KC UNN 25 96 120 Versioning NEE 60 MINUS SCARING ike ie ee eh 29
22. Logon is based on the mechanisms of the Windows operating system There are two user adminstration options here e Centralized adminstration in a domain structure e Administration on one computer of a work group When using multiple servers or when there are redundant servers the domain structure must be used to ensure that users will still be able to perform operations SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 31 System Installation and Configuration and log on even if one domain server fails However the domain server functional ity may not be installed on a PCS 7 system Note The complete name for each user must be entered under Local users and groups in the Windows Computer Management This name is used for the display in SIMATIC PCS 7 after logon to the application Therefore this field must not be left blank See also e Manual Security Concept PCS 7 and WinCC e Manual PCS 7 Compendium Part A Chapter 1 2 Workgroup and domain While a user is authenticated for his operator rights in the SIMATIC environment when he logs on a standard user is always logged on to the operating system at the same time and has the permissions required for the operating system level power user as a minimum Note The user logged on to the operating system should be the same one throughout the entire system he should be logged on automatically when an OS computer starts up Ad mintsirators Adminia
23. Monitoring PCS 7 components SIMATIC PCS 7 Lifebeat Monitoring allows the functionality of automation and operator stations to be monitored To facilitate this all automation and operator stations must be configured in HW Config and the OPC connections to the opera tor stations must be created To configure the nodes to be monitored in WinCC Explorer select the menu command Editor gt Lifebeat monitoring gt Open Here all the nodes to be monitored and the monitoring cycle in which lifebeat monitoring will be performed can be configured The lifebeat monitoring is activated automatically when the OS starts up Alternatively all process control equipment can also be managed in the PCS 7 Asset Management A maintenance station MS provides an overview of the diagnostic and service information for all equipment Asset management does not require any additional configuration The configuration data are generated from the hardware and software configuration data SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 85 Creating Application Software 6 8 6 6 9 86 Monitoring connected systems Lifebeat monitoring for connected systems must be configured manually Its use depends on the corresponding communication partner If the connected system represents an important interface to SIMATIC PCS 7 lifebeat monitoring is absolutely necessary Coupling 3 party systems to PCS 7 via Ethernet and OPC _ OS Server
24. OS User Administration and the required rights assigned The following procedure must be followed for this e Open PCS 7 OS project e Open user management via WinCC Control Center e Create the group s e Assign the permissions for each group The figure below shows how operator rights are assigned to individual groups SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 39 System Installation and Configuration ZE User Administrator OS mcp File User Table View or AddOns Help al Ei Be on ne E l SE EE Login Administratorer In SIMATIC Logon ese ti Administrator Gruppe L Logi E ja Chip card Web Navigator EF Administrators Automatic logout i Leg Emergency Operator Operator ARE User User administration Authorization for area D system change Pr a R ocess controlling CS ec C SS SG SG Dat Monitor Justmonito SG amp amp SG SS S oe ZS Report system CS WS H E EX E EX E amp amp S SS S amp S SS amp SS S esas OO OO OB OB B a _ 1000 1001 1002 Note Especially in regulated environments centralized management of users such as that provided by SIMATIC Logon is essential in many situations The check mark for activation of SIMATIC Logon must be set in the PCS 7 OS User Administration of the respective PCS 7 OS computer SIMATIC PCS
25. Project Settings and Definitions 48 in the master data library The PCS 7 standard libraries include templates that can be used Recommendation The modules and typicals must be verified with a module test and approved by the customer prior to instantiation Not only must the same versions of faceplates SFC types and typicals be used in all projects within a multiproject but such projects must also be based on a common plant hierarchy and shared declarations The individual projects must be synchronized with the master data library for this See also e Product Support http support automation siemens com DE FAQs e Product Support http support automation siemens com DE view de 22258951 Multiproject Engineering e Product Support Multiproject Engineering with SIMATIC BATCH Note SIMATIC Version Trail is used to clearly archive and organize versions of the master data library during the course of the project The faceplates SFC types and shared declarations are the smallest user software modules These are used in creating process tag types and models which are then duplicated either manually or via the IEA interface see also chapter 6 2 Engineering with the IEA for more on this See also e Manual PCS 7 Compendium Part A chapter 5 2 1 Process tag types templates SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 Project Settings and Definitions Master data library Programming creat
26. SIMATIC PCS 7 TELECONTROL MODBUS Driver 7 0 1 Single Unlimited Unlimited SIMATIC PCS 7 Route Control Server 30 7 0 1 Single Unlimited Unlimited SIMATIC PCS 7 BATCH API 7 0 1 Single Unlimited Unlimited SIMATIC PCS 7 PDM Routing 6 0 1 Floating Unlimited Unlimited kg SIMATIC PCS 7 Telecontrol Server 7 0 1 Single Unlimited Unlimited SIMATIC PCS 7 BATCH Library 7 0 1 Single Unlimited Unlimited me SIMATIC PCS 7 SFC Visualization mal 1 Floating Unlimited Unlimited SIMATIC PCS 7 IEA 1 Floating Unlimited Unlimited kg SIMATIC PCS 7 BATCH Recipe System 7 0 1 Floating Unlimited Unlimited _ SIMATIC PCS 7 45 RT PO 1 Floating Countable objects 2000 2000 _ SIMATIC PCS 7 TH PO Go 1 Floating Unlimited Unlimited SIMATIC PCS 7 CFC 7 1 1 Floating Unlimited Unlimited kg SIMATIC PCS 7 BATCH 10 UNITs 7 0 1 Single Unlimited Unlimited mm SIMATIC PCS 7 BATCH Hierarchical Recipe 7 0 1 Single Unlimited Unlimited SIMATIC PCS 7 Maintenance RT 1 Single Count relevant 200 SIMATIC PCS 7 Route Control Center 7 0 1 Floating Unlimited Unlimited SIMATIC PCS 7 installation log When SIMATIC PCS 7 is installed the current status of the installed system programs is saved in the citamis str file Retro installations are also documented Depending on the operating system installed this file is located in either the WINNT or the WINDOWS folder D sw_citamis str WordPad Datei Bearbeiten Ansicht Einf gen Format poem ae al e s
27. SIMATIC PCS7 V7 1 GMP Engineering Manual 30 A5E02795571 01 4 1 4 2 4 3 4 3 1 System Installation and Configuration System Installation and Configuration Installation of the Operating System When selecting the operating system observe the information given in chapter 3 and the sources named therein See also e Installation instructions for the operating system e Manual PCS 7 PC Configuration and Authorization Installation of PCS 7 To install SIMATIC PCS 7 follow the instructions of the setup program When required approved third party components e g Office must be installed prior to installing PCS 7 More installation information is contained in the e Manual Security Concept PCS 7 and WinCC e Manual PCS 7 PC Configuration and Authorization e Manual PCS 7 Released Modules e PCS 7 Installation DVD Readme Note SIMATIC Logon must be selected in the installation setup Setting up User Administration An automated production plant is safeguarded against unauthorized access by implementing access protection which protects against access on the operator control level and the ES and OS configuration level and protects backup copies and archives as well A user specific logon logoff procedure for operator actions is another important basic feature for meeting the requirements in a pharmaceutical environment User administration on the operating system level Administration of user rights using SIMATIC
28. They supply an output voltage free of interference voltage electromagnetic interference frequency variations and voltage distortion More detailed information on the different MASTERGUARD ranges can be found in the SIMATIC PCS 7 catalog SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 Support during Verification 7 Support during Verification With the expanded view of computer systems beyond the immediate manufactur ing sector the term verification has begun to be used in GAMP5 and other recommendations The aim of verification is documented proof from testing e g FAT SAT to ensure that the system meets specified requirements URS FS Various standard functionalities of SIMATIC PCS 7 can be used as support for such verification Planning Reporting Configuration and or Coding Supporting Processes including Risk Management 7 1 Test Planning In defining a project life cycle various test phases are specified Therefore basic activities are defined at a very early stage of the project and fleshed out in detail during the subsequent specification phases The following details are defined at the outset of the project e Parties responsible for planning and performing tests and approving their results e Scope of tests in relation to the individual test phases e Test environment test design simulation Note The work involved in testing should reflect not only the results of the risk analysis bu
29. alarm in the process Power returns control system documents the power failure and the after 25 shutdown of the process control system after 20 minutes minutes The UPS stops supplying power after a defined time for example 25 minutes so that an independent restart of the process control system computers is possible once the power has been restored Power failure The process control system computers are buffered by gt 1 hour the UPS e g for 20 minutes An alarm in the process control system documents the power failure and the shutdown of the process control system after 20 minutes The UPS stops supplying power after a defined hold time to ensure that the process control system computers can restart independently after restoration of power 6 13 2 UPS configuration via digital inputs In addition to the standard buffering provided by UPS devices the option of monitoring the power supplies should be used In this case the phase is monitored via one or several digital inputs The failure of the energy supply can be registered via alarm messages and archived during production in the batch report This guarantees a complete record of the plant problems UPS buffering of load voltage The automation CPU is supplied with power by the UPS 24 V module both during voltage dips and longer power failures The phase monitoring module monitors the status change during a power failure using a digital input that should be designed as a fai
30. and tested by means of the following information for example e Identification of manufacturer and type e Order number e Number of racks e Verification of the hardware components used CPU CP etc e Number of distributed I O stations e Interfaces to third party systems e Address number SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 Support during Verification Note HW Config printouts support the relevant documentation The control cabinet documentation must also comply with HW Config Verification of the network structure The information below is an example of the data which should be specified and tested for verification of the network structure e Name of station PC AS clients etc e Communication module type of connection and communication partner Ethernet PROFIBUS serial etc e MAC address when using the ISO protocol on the plant bus e TCP IP address and subnet mask when using clients e PROFIBUS addresses Note The SIMATIC NetPro configuration can be printed out Verification of the employed PC hardware The information below is an example of the data which should be specified and tested for verification of the PC hardware e Manufacturer type designation essential components e Additionally installed hardware components additional network adapter printer etc e Verification of the configured network addresses screen resolution etc Note Utilities can read detailed
31. be history used before an old password of the user account can be reused Password must meet When activated the password must be made up of at least three complexity of the four following categories EECH Upper case letters A Z Lower case letters a z Numeric characters 0 9 Special characters etc Maximum password Specifies the minimum number of characters a password must length contain Maximum password Specifies the maximum length of time a password may be used age before it must be changed Minimum password age Specifies the minimum length of time a password must be used SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 33 System Installation and Configuration Account lockout policies The security mechanisms for account lockout policies such as the number of permissible failed logon attempts are set in the operating system Guideline si Description of security setting Account lockout threshold Specifies the number of failed attempted logons before the user account is locked out Account lockout duration Specifies how long an account is to remain locked out before the lockout is lifted automatically If the value is set to 0 the account will remain locked out until it has been explicitly released by an administrator This is the recommended setting Reset account lockout Specifies how many minutes must elapse after failed logon counter after attempts before the account lockout counter is r
32. change control procedure All configuration elements must be maintained in a transparent manner right from the start of system s creation SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 59 Project Settings and Definitions 5 8 5 8 1 Note Chapter 5 8 Versioning Software Elements includes examples of how individual software elements can be versioned Change control of various elements is explained in chapter 6 9 CEEE and chapter 7 4 peration Always consult the plant operator to agree upon a procedure for making changes to a plant in ongoing operation see chapter B d hange Control during Operation See also e GAMP5 Guide Appendix M8 Project Change and Configuration Management Versioning Software Elements The project guidelines must define which elements are to be versioned when versioning is to take place and whether a major version or minor version is to be incremented for example The major version is set to 1 0 following the FAT and to 2 0 after commissioning All other changes are reflected by incrementing the sub version However whether the main version or the sub version is to be changed can also depend on the scope or effect of the change in question Note The version author and comment fields can be written using the Import Export Assistant IEA The following sections show various examples of software element versioning which basically differ in the following e AS elemen
33. computer systems This chapter deals with the most important sets of regulations and explains some of the basic ideas Regulations and Guidelines The regulations guidelines and recommendations of various national and interna tional agencies and organizations have to be taken into account when configuring computer systems requiring validation in the GMP environment Where computer systems are involved the following are of particular significance Name Title author 21 CFR Part 11 Electronic Records Law regulation for US FDA Electronic Signatures manufacturers and importers of pharmaceutical products for the US market Annex 11 of the EU Computerized systems Binding directive GMP Guidelines within the European Union for implementation in relevant national legislation European Commission A Risk Based Approach to Guideline with worldwide validity as Compliant GxP recommendation Computerized Systems Life Cycle Model A central component of Good Engineering Practice GEP is the application of a recognized project methodology based on a defined life cycle The aim is to deliver a solution known as the risk based approach that meets the relevant requirements GAMP5 approach The following figure shows the general approach for development of computerized systems according to GAMP 5 It begins with the planning phase of a project and ends with the start of pharmaceutical production following completion of the tests and r
34. designed redundant It does not require a connection to the plant bus It is used for the long term archiving of messages process values and reports Process values and messages which have been swapped out of the OS archives as well as OS reports and SIMATIC BATCH batch data can be displayed either on the OS clients directly or by using the StoragePlus Viewer integrated in the CAS The cycle for transferring data managed by the CAS can be configured as can the associated segment size All clients which access archive data short term and long term archives must feature the server packages required by the server involved as well as the CAS server package Operating principle 100 Since the CAS is integrated in the PCS 7 system process archive values can be clearly displayed on the OS clients in the form of trends and tables To facilitate this the CAS server data package must be stored on the OS clients when the system is configured or when a change is made to the system configuration Access to Tag Logging archive data for a defined time period is handled automati cally within the system This means that the user does not need to worry about whether selected archive data is still available on the OS servers or whether it has already been transferred to the CAS If the CAS has already transferred selected archive data to an external storage medium with the result that the data is no longer connected to the CAS database see cha
35. etc See also e Manual WinCC V6 Basic Documentation e Manual PCS 7 Compendium Part A chapter 7 4 1 Archiving Introduction 6 12 3 Archiving batch data Batch data is stored in XML format in the SIMATIC BATCH for long term archiving You can choose between two formats The XML files are protected by checksums Project settings for BATCH_TEST_EN Ea Used Plug in Modules Report Electronic signatures General warnings Color Font Archive Versioning Vaimatic emp ES a SOL Server D Create C FTF Server Configure User specified information Domain Logon Password h Generate PDF file automatically Test i V7 0 5P1 Default Cancel Help SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 99 Creating Application Software 6 12 4 A batch archive in format V7 0 can be used by the standalone application SB Report while format 7 0 SP1 is particularly useful as data exchange format to external applications for further processing A PDF report can be created regard less of the format When specifying the archive path it should be ensured that the batch data is stored in a directory protected by Windows security mechanisms or in a database and is therefore only accessible to authorized persons or systems Long term archiving with the Central Archive Server CAS The CAS Central Archive Server is a standalone server PC which can also be
36. ge LI Object Sequence Hot water valve Version Author Comment Vio M Meyer New constuction Vii M Malte Expansion ON Function SIMATIC PCS7 V7 1 GMP Engineering Manual 62 A5E02795571 01 Project Settings and Definitions FSiLAD STL FBD FB1 EM_TEMPLATES SIMATIC 400 CPU 417 4 4 File Edit Insert PLC Debug wiew Options window Help Diels S slee ol ei fa Se e o sl HHH el Contents Of Environment Interface Ets Interface Max Mustermann W1 0 2007 09 01 ject V21BR1 Hotwater valve sequence Definition global Variable Note Another possible variant is versioning on the unit level if the plant has an appropriate structure The unit and lower level elements are managed and versioned as functional units The version of the unit can be transferred to all elements using the Find Replace function in the process object view Version and change comments must then be maintained in the unit CFC SIMATIC Manager est abies GER F PCS7_Projekte BF_Kurs_Voll SB_MP Sb ES File Edit Inser PLE Help Die Sc sale EI Es S pr ei Es CR Du v General Parameters Signals Messages Picture objects Measured value archives d Si test Neu_TPlan Filter by column Display Neu_TPlan2 j e k No filter gt Gj Neu_TPlan3 Li z Production a EI Branche EE Auto Versior ES 4 T M ae LI Automation J JE Branche2 a
37. information about the configuration of the computer and print it as a documented proof SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 111 Support during Verification 7 3 7 3 1 112 Verification of Software Software categorization according to GAMP Guide According to the GAMP Guide the software components of a system are assigned to one of four software categories for the purpose of validating automated systems In terms of a PCS 7 system this means that the individual software components require different amount of effort for specification and testing depending on their software category Category 1 Infrastructure software Scope of testing Check and document the version number Check and document the correct installation Basic installation including editors CFC SFC Graphics Designer Faceplate Designer etc Category 3 Unconfigured products Scope of testing Check and document the version number Check and document the correct installation Check functions Batch Server Redundancy Set up redundancy and check functionality WinCC Redundancy Set up redundancy and check functionality Lifebeat Monitoring Function test Time synchronization Set up time synchronization and clock master Siclock Check functionality Documentation of the configuration test SE field components in IQ LoopCheck SIMATIC Logon Test in the context of access control and user permissions user management SIM
38. plan See also e GAMP5 Guide Appendix M6 Supplier Quality and Project Planning SIMATIC PCS7 V7 1 GMP Engineering Manual A5E0279557 1 01 Configuring in a GMP Environment 1 4 Approval and Change Procedure When new systems requiring validation are set up or when existing systems requiring validation are changed the top priority is to achieve or retain validated status which means ensuring the traceability of the steps undertaken Before setting up or modifying a system it is therefore necessary to plan and document the pending steps in terms functionality and time and to obtain approval by the customer respectively by the plant operating company 1 5 Risk Based Approach Both the US agency FDA cGMPs 21st Century 2004 and the industry associa tion ISPE GAMP GAMP5 guidelines 2008 recommend a risk based approach to the validation of systems This means that whether and to what extent a system should be validated depends on its complexity and its influence on the product quality SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 13 Requirements of Computer Systems in a GMP Environment 2 1 Requirements of Computer Systems ina GMP Environment This chapter describes the essential requirements an automated system must meet in the GMP environment in terms of using computer systems These require ments must be defined in the specification and implemented during configuration When subsequent modifications o
39. such as the duplicate assign ment of network addresses to problems with viruses and even the possibility of attacks by computer hackers In certain applications the SCALANCE S security modules can be used to coun teract these risks They basically offer two different functions If a firewall is used only registered nodes can communicate over the network See also e Product Support http support automation siemens com DE FAQs on the topic Communication Networks e Product Support http support automation siemens com DE view de 2237674 Protection of an Automation Cell using the Security Module SCALANCE S602 via Firewall and the document attached there SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 System Installation and Configuration VPN A virtual private network VPN links external computers to the local network and is also capable of encrypting the transferred data A VPN connection enables external systems to perform secure remote access over the Internet To do this SCALANCE S technology uses the IPSec protocol which provides an extremely high level of security in tunnel mode VPN tunnel See also e Product Support http support automation siemens com DE FAQs on the topic Communication Networks e Product Support http support automation siemens com DE view de 2205671 Industrial Security with SCALANCE S Modules Over IPSec VPN Tunnels and the document attached there Note SCAL
40. the open closed feedback message Blocks from the PCS 7 standard library were used for the example above In accordance with GMP requirements the parameter assignment and the inter connection of the inputs and outputs must be described in detail in a suitable specification Software Module Design Specification for example and verified by means of a test software module test or typical test See also e Manual PCS 7 Compendium Part A chapter 5 2 1 Process tag types templates Recommendation Consideration can also be given to the settings for process value archiving for example when creating the process tag type 6 1 3 Automatic generation of block icons Graphic block icons are used to display information relating to process states e g valve open closed faulty etc on the PCS 7 operator station OS PCS 7 offers graphic templates for all blocks contained in the PCS 7 library thus supporting the type instance concept from the function block in the AS through to the operator component in the PCS 7 OS plant pictures PCS 7 provides several templates for use SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 69 Creating Application Software Note Generating block icons automatically reduces the risk of an error occurring See also e PCS 7 on Tour Basic chapter 10 5 1 Adapted block icons and faceplates If the Create Update Block Icons function is executed the block icons are derive
41. 0 E lt allocate SC ioe gr bb i Creator Max Mustermann am Ely graphics A Object V21BRI E DH tag M Description Actions valve 100 000 E DZ get oO B state Mersion Comment Date Bey Staten MEARAN New draw 27 06 2006 wait yal Expansion GetTagBit 20 08 2007 AE GetTagBit E GetTagByte PCS _OpenGroupDisplay vb loszPictureName Ipsz0bjectame GetTagChar E GetTagDouble GetTagBbit Tag_Name Return Type BOOL GetTagD Word d e bf e le wk Version and comments added within a script 5 8 3 Additional information on versioning Versioning of BATCH elements Recipe versioning is described under Change Control for Recipes in chapter 6 9 3 IMATIC BATCH Versioning projects multiprojects and libraries Supporting system functions for versioning projects etc are described in chapter 74 onfiguration Control SIMATIC PCS7 V7 1 GMP Engineering Manual 66 A5E02795571 01 6 1 Creating Application Software Creating Application Software This section details information and recommendations to aid in the creation of application software in environments subject to GMP Software Modules Types and Typicals Software modules or typicals in the form of function blocks function charts or complex step sequences are widespread in the process control engineering You can create in advance and reproduced them during the design phase Note Modules and typicals are defined with the aim of not only
42. 00iSP PROFIBUS DP can even be used in hazardous zone 1 This makes data transfer rates of up to 1 5 Mbps possible even in hazard OUS areas Complex process I O devices such as those listed below can be linked to PCS 7 using predefined add on blocks e SIMOCODE pro motor management system e MICROMASTER 4 frequency inverters e SIWAREX weighing system Also available e Function modules e g closed loop controllers motor starters etc e HART modules for integrating HART field devices e F modules for fail safe applications e Ex modules connection of actuators sensors from zone 0 or 1 All HART modules can be configured via the PDM see chapter 5 4 4 IMATIC PDM PROFIBUS PA Profibus PA can also be easily implemented or designed redundant See also e Operating instructions Bus links DP PA coupler DP PA link and Y link Note When configured as a diagnostic slave the FDC 157 0 DP PA coupler is fully integrated into plant level PCS 7 Asset Management SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 53 Project Settings and Definitions 9 4 4 SIMATIC PDM SIMATIC PDM Process Device Manager is a software package for the configura tion parameter assignment commissioning and maintenance of devices for example transducers and the project engineering of network configurations and PCs Among other things it enables process values and alarms as well as device status information to be monitored easil
43. 1 Configuration Control Versioning Projects with Version Trail SIMATIC PCS 7 Version Trail can be used to archive multiprojects single projects and project specific libraries with a unique version ID Archiving is performed in accordance with the PCS 7 archiving procedure Project specific libraries are also saved when a multiproject is archived which means they remain assigned to the relevant multiproject SIMATIC PCS 7 Version Trail ensures continuous incrementation of the version according to validation factors A completed version can no longer be changed However every archived version can be read back into the system Since GMP requirements demand that SIMATIC Logon be used all relevant actions are saved with details of the logged on user Note Before a multiproject is archived a check must be performed to ensure that no projects or libraries belonging to the multiproject have been removed This is because only projects and libraries contained in the multiproject at the time of archiving will actually be archived For more information see Online Help of SIMATIC PCS 7 the topic of Version Trail and the configuration manual PCS 7 Engineering System Procedure for archiving projects 120 Each archived project version can be retrieved in the SIMATIC Manager or by using Version Trail In a validated plant however previous project versions can only be read back retrieved in exceptional cases and in consultation w
44. 5571 01 Creating Application Software and e Allow editing of recipes in the Release revoked status property deactivated Project settings for DEMO6_HF sl T wa RERRRKERER If these settings are made the message below is output if a change is to be made to a recipe SIMATIC BATCH Recipe Editor The recipe can only be edited after Save As has been used The following prompt is displayed Gave ag SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 91 Creating Application Software Note If a new recipe based on a recipe which has already been released is to be created using Save As the new recipe must first be generated using the Save As function before any change is made to the existing recipe Product Support Support automation siemens com DE view de 23378328 This ensures that once a recipe is released it cannot be edited later without changing the version or name If recipes are deleted this is recorded in the log see figure Log H l0 x Name Type lt All types gt v Date From 2008 01 24 11 54 13 UTC 1 00 il to 2008 01 30 16 15 42 UTC 1 00 4 sl User eal users gt D Comment 14 Hide settings Type Action Name Date Users Comment Code version Archive Restore performed From backup File Archive of PCell P 2008 01 24 11 54 13 UTC 1 00 Workshop user Restore aus Archive Archive of PCell P 2008 01 24 11 54 13 UTC
45. 7 V7 1 GMP Engineering Manual 40 A5E02795571 01 System Installation and Configuration 4 4 3 Rights management in SIMATIC BATCH Permissions and roles are assigned in the SIMATIC BATCH application using SIMATIC Logon Role Management 3 7 SIMATIC Logon AdminTool ajx Fie Edt CY al ir ye E ER Operator Pe Process engineer ER Aubomation enginsar ES Emesgency operaba ER Logon Administrator DS Super User TASS eA a Groups and users 7 Groupe and users DR wl Available gaupe vailable Groups and users Groupe and users Groupe andusers Domaine Description E SS SPRING this computer Batch Users SPRING Batch Users except Logon Administrator Dave_engreer SPRING Batch User Edit Groups and users Role Super User conhigured Groups and users Configueed Groups and users Avaflable Groupe and users Domain SPRING this computer E SPRING SPRING SPRING SPRING SPRING es SPRING SPRING SPRING SPRING la Help The individual roles are assigned to operator rights in SIMATIC BATCH The following can also be defined e User rights of a user role see the following figure e Permitted user roles per computer e Permitted user roles per unit SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 41 System Installation and Configuration Permission management E View permissions of the logged in user Change Log Individual permissions Computers
46. 71 01 61 Project Settings and Definitions Use the right and left cursor keys of the version number to increment the minor or major version If make an incorrect entry only to last saved version can be decre mented Changes the version number must always be performed by the project worker at their own risk Note Once saved a version number can no longer be reversed The project worker must carefully examine his entry before confirming with OK The version number can be set in the range 0 0001 to 255 4095 Information on the version history can also be added to the chart as a separate comment in the form of a text field SCH UNIT EM_TEMPLATES Process_Cell Unit01 E Chat Edt Insert CPU Debug Yew Opbons Window Help Doel a RRE leie ACL i ele UE ee l New Text H Al blocks BATH e COMPARE CONVERT FLIPFLOP Sm FP e hum mi EAsFc TEST EM_TEMPLATES SIMATIC 400 CPU A1 TA ES FC Edt Inset CPU Debug Wew Options Window De Author Comment pan M Malte New constructio 5 08 12 P Mayer Expansion UNITO Block 1007 09 03 e 6 HI Sam e pi SHIFT S w osla siele S5 m 3 ail EA alaj aain wj DS Poan fe Pl al abi Characteristics to TEST DR Characteristics Control strategies E Setpoints Process values Control values Parameters gt Bit memory D Timers Contents Of Characteristics Control strategies Name Display name Se t e Gemen ON_RIC 2
47. ANCE S technology offers various applications More information can be found in the manuals of the SCALANCE product series SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 45 Project Settings and Definitions 5 5 1 5 2 46 Project Settings and Definitions Multiproject Setup Multiproject engineering allows a project to be divided into several sub projects so that it can be worked on by more than one person A higher level multiproject which contains the individual projects AS OS SIMATIC BATCH and the master data library is defined in the SIMATIC Manager Projects can be added to and removed from the multiproject The master data library supports consistent data management within the multiproject Note In a controlled environment in particular it is essential to use the master data library to centrally manage process tag types models SFC types and shared declarations The SIMATIC PCS 7 New project wizard assists you in creating projects It automatically creates a multiproject The project name to be assigned must be previously defined in the software specification as it can be difficult to subse quently rename a project See also e Manual PCS 7 Compendium Part A chapter 2 2 Required settings in the SIMATIC Manager and 2 3 Automatically creating a multiproject A new sub project can be added to an existing multiproject as an empty or a preconfigured project For projects whose size me
48. ATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 Support during Verification Category 4 Configured products Scope of testing Check and document version number Check and document correct installation and configuration Risk based test for proof of correct operation in the test environment and in the business process CFC template process tag type CFC instances FBD function block diagram LAD ladder diagram SFC charts SFC Type SFC Instances EENEG lene Graphics faceplates trend pictures etc Control SIMATIC BATCH Engineering Create and test recipes unit recipes Equipment modules etc StoragePlus CAS Central Archive D Set up archiving Server Function charts Route Control Engineering Configuring and test routes OPC Server Client OpenPCS 7 Configure interface and test data therein Category 5 Customer specific applications Scope of testing Check and document version number Create and release design Check and document correct installation and function of source code Risk based test for proof of correct operation in the test environment and in the business process Create blocks STL statement list BATCH Advanced Report Create report log templates BATCH API Interface Applicative interface to SIMATIC BATCH While a PCS 7 system configured customer specific as a whole would usually have to be assigned to category 4 or sometimes even 5 the individual standard compo nents to be
49. Awww siemens com automation service amp support There you will find The newsletter that provides you with latest information relating to your product The right documents for you using our Service amp Support search engine A bulletin board in which users and specialists worldwide exchange their know how You local Siemens representative Information about on site services repairs and spare parts And much more under Services SIMATIC PCS7 V7 1 GMP Engineering Manual AS5E02795571 01 Introduction SIMATIC PCS7 V7 1 GMP Engineering Manual 6 A5E02795571 01 Table of Contents Table of Contents NEO TEE 3 TIDE OFCON E 1 Configuring in a GMP Environment cccccssseeesesseeeseesneeseeneeeseesseeeeeeseesseeseesseasnessoees 1 1 Regulations ANd Guidelines isxseccise scan sotedsianonensunadoad Edge Sg 1 2 Life Cycle le e EE 1 3 RESPONSIDIIIGS ace cceereete secs epescice ew tania EE AEEA EEE EEEE Ea 1 4 Approval and Change Drocecdure 1 5 RISK BASCA APMOAC eege 2 Requirements of Computer Systems in a GMP Environment 2 1 Categorization of Hardware and Software ccccccecccccseeeeeeaeeeeeeeeeeeeaeeeeesaeeseeesaaes 2 2 Test Effort Depending on the Categortzaton 2 3 Project Change and Configuration Management 2 4 SEET eege eege Dee eebe 2 5 Access Protection and User Management 2 5 1 Applying access protection to a svsiem 2 5 2 Requirements of user IDs and passwords 2 6 Requirements of Electronic
50. BERT 1483_P03_ QOPENING 0 SUBS_ON_ 0 0 SIMON _QUALITY 0 SUBST 0 del DI CLOSE CH DI T S MODE S4VALUE SIM ON SIM I i EM j IN_OUT B00L Simulation value Disabling simulation Note Enabled simulations should be documented in accordance with good practice A table provides an overview of all active simulations On completion of the test phase all simulations must be disabled again Recommendation Where possible central switches which are interconnected with all input drivers can be configured for specific units to enable disable simulation On completion of the tests this central switch can be deleted or disabled thus switching simulation off from a central location SIMIT simulation software The SIMIT simulation software enables a software test to be performed via a simulation platform without the need for the actual field devices SIMIT simulates field devices and facilitates not only simple signal tests at the touch of a button but also complex function tests such as temperature control Used in conjunction with the S7 PLCSIM PLC simulation software which simulates the CPU of an automation system it enables software tests to be performed without an automation station or field devices and can be used by the software provider to perform the Factory Acceptance Test FAT for example SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 119 Support during Verification 7 4 7 4
51. COMIGUI AN OMe EEN 4 6 IFMOFMIATION SCCUMLY suisses anaa a EE E TEE T 4 6 1 SIMATIC Security Control GC e O CALANGC E 5 Project Settings and Definitions ccccscceceseseeeeeeneeeseseeeeeeneesseeseeseeeseeseenseeseneneesenens 5 1 Multiproject Getup MA 5 2 Referenced OS de EE 5 3 Using the Master Data Library REENEN ENEE 5 3 1 Synchronizing shared declarations AA 49 592 SOVMCIFONIZING SFO TEE 50 5 3 3 Synchronizing the plant berarchy AA 5 4 IMAR C NE eege 5 4 1 Configuring SIMATIC NET ogeechatierGide retegettSete et Ek ege dE SEN gege EEeEEE dE 9 4 2 Plant bus and terminal bus REENEN oi SC ME EE SAA NATIE PON eet 5 4 5 FOUNDATION Fieldbus FF sccvisccnccdienecssienicenniantsceencsetnluwtausiesinavesudianttivsinedatsictnenwswnsades 55 5 5 Bee e e EE 5 6 Time Synchroni atio sass r A Ri 5 7 Configuration Management 5 8 Versioning Software Elements 5 8 1 Versioning AS elements in PCS 7 ccccccccccccseseeecceeseeeceseeecseseecesaseeessageeessneeesseaes SIMATIC PCS7 V7 1 GMP Engineering Manual 8 A5E02795571 01 Table of Contents 5 8 2 Versioning OS elements in HU 5 8 3 Additional information ON versioning ccccceseeeeeeceeeeeeeseeeeeaeeeeeeeeeeeeesseeeeesaeeeeessaaes 6 Creating Application Software ccccccssseeesseeeessesseeeseeneeeseeseeeseesneeeeeseeeseesseeseneneessoens 6 1 Software Modules Types and Typical cccccseccccceeeeeeeeeeeeseeeeeesaeeeeesaeseeesaees Bt
52. GMP Engineering Manual Edition 06 2010 SIMATIC PCS 7 V7 1 Guidelines for Implementing Automation Projects ina GMP Environment SIEMENS SIMATIC PCS 7 V7 1 GMP Engineering Manual Guidelines for Implementing Automation Projects in a GMP Environment 06 2010 A5E02795571 01 Introduction Table of Contents Configuring ina GMP Environment Requirements of Computer systems in a GMP Environment System Specification system Installation and Configuration Project Settings and Definitions Creating Application Software Support during Verification Operation Maintenance and servicing system Updates and Migration Index List nN m Ja LO Legal information Warning notice system This manual contains notices you have to observe in order to ensure your personal safety as well as to prevent damage to property The notices referring to your personal safety are highlighted in the manual by a safety alert symbol notices referring only to property damage have no safety alert symbol These notices shown below are graded according to the degree of danger ViINDANGER indicates that death or severe personal injury will result if proper precautions are not taken WARNING indicates that death or severe personal injury may result if proper precautions are not taken CAUTION with a safety alert symbol indicates that minor personal injury can result if proper precautions are not taken CAUTION witho
53. License Manager File Edit LicenseKey view Help Ogag T x ii Je license keys 40g E HI My Computer i H 314 Floppy 4 BD system C g Data D i Status Family Product version Number of license keys Standard license type License type validity u Meetinger E SIMATIC STEP 7 STEP 7 5 4 1 Floating Unlimited Unlimited Web License Key Dowr e e K mme kg SIMATIC STEP 7 version Trail ol 1 Floating Unlimited Unlimited SIMATIC STEP 7 57 5CL 5 3 1 Floating Unlimited Unlimited SIMATIC STEP 7 57 PLCSIM 5 4 1 Floating Unlimited Unlimited ec SIMATIC STEP 7 version Cross Manage 7l eeneg Dog ees Unimited Unimited S 01 anes eileen 2 een nt Cee See em pee Si mm SIMATIC PCS 7 PCS 7 Web Server 3 Al 1 Single Unlimited Unlimited SIMATIC PCS 7 FE Til 1 Floating Unlimited Unlimited SIMATIC PCS 7 BATCH Batch Planning 7 0 1 Floating Unlimited Unlimited _ SIMATIC PCS 7 BATCH Formula 7 0 1 Single Unlimited Unlimited _ SIMATIC PCS 7 BATCH BatchCc 7 0 1 Floating Unlimited Unlimited keng SIMATIC PCS 7 Route Control Engineering 7 0 1 Floating Unlimited Unlimited kg SIMATIC PCS 7 Maintenance ES K 1 Floating Unlimited Unlimited _ SIMATIC PCS 7 PDM HART Mux 6 0 1 Floating Unlimited Unlimited SIMATIC PCS 7 TELECONTROL SINAUT Driver 7 0 1 Single Unlimited Unlimited SIMATIC PCS 7 PDM Basic 6 0 1 Floating Unlimited Unlimited SIMATIC PCS 7 OPC DBA 7 0 1 Floating Unlimited Unlimited
54. Modules and typicals in PCS est 6 12 Example of a process t g VO sicsccacdsecs cere riccsdeeesceusedd iene a aa a eE 6 1 3 Automatic generation of block ICONS ccccccceeceeeeeeeeeeeeeceesaeeeeesaeeeeeeseaeeeesaeeeeesaeees 6 2 Bulk Engineering with the EA 6 3 Creating Process Diagrams cccccsssccccssseecceesececseueeccsuseeecsageeecseseesssseeessageeesseaes 6 4 User Specific Blocks and Scripts cccccccceececeececeeseeceeeeceeceseeecessaeeeseeeeseneeeseeeees 6 5 WEE EE od ME e Wep OPIO EE ee EE hee EE 65939 SIMANC E EE E 6 6 Recipe Control with SIMATIC Batch ccc ccccccceccessececeeeeeseeeessecesseeeeseeeeaeeeeseeeeees SR ME Bee reine EE 6 6 2 Conformity with the ISA 88 01 standard 6 6 3 Important settings in SIMATIC BATCH 19 664 Creating Dath elle E 6 7 SIMATIC Route Control 6 8 Alarm UW VAN LC VN TAN pe acters dtr teeter clea belts erent enade eari aeaa aerieni iaa 8 OOL POS CIC AMON EE 8 OOZ Massage CIS SCS eege a a a ernan ana 8 Oaa Lei EE 8 6 8 4 Suppressing filtering NIGING cccceecccccseeeeeseeeeeeeeeeeeeseeeeeeseeeeeeseaeeeseeeseesaeeeeeesenss 8 6 8 5 Monitoring PCS 7 components 6 8 6 Monitoring connected systems 6 9 Audit Trail and Change Control s SG De NEE E S E 87 SE GC PES EEN A MANC HE e EE 6 10 Configuration for Electronic Signatures ccccccccceeeeeeceeeeeeeseeeeeseeeeeeseeeeeesaeeeeeesaees 6 10 1 Electronic signatures in SIMATIC BATCH nnsnsnnnnnsnnn
55. N OHIO 1 1 Condition monitoring It is often necessary to take into account certain process engineering chemical and mechanical conditions in a plant s maintenance concept Condition monitoring e g pump operating points motor bearing monitoring is generally used in a preventive capacity in this regard as the user receives an automatic notification before critical conditions are reached PCS 7 Asset Management enables user specific maintenance relevant process variables or parameters to be integrated into the existing diagnostic structure PCS 7 provides the appropriate interfaces for this a function block on the AS anda faceplate on the OS 8 1 3 Regular Data Backups To avoid loss of data regular data backups are not only necessary in the project phase Also in the operating phase different backups need to be done to guarantee system recovery in case of system or data damage In addition a system recovery plan is needed The following backups should be taken into account SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 127 Operation Maintenance and Servicing 8 2 8 3 128 e Image of basic installation without SIMATIC installations once during system installation e Image of system installation including SIMATIC installations once during system installation e Change driven backup of project data before and after a change e Image of PC installation including all project data after system updates and
56. Note Use of the Web option in a controlled environment must be thoroughly discussed with the customer Issues such as access to the web client critical or non critical operator control and monitoring functions Logon and audit trail as well as a secure data connection must be considered during these discussions For more information on the use and configuration of the Web option refer to chapter 6 5 1 PCS 7 OS Web Option and to the manual PCS 7 OS Web Option SIMATIC BATCH basics and options The SIMATIC BATCH software is integrated in SIMATIC PCS 7 It can be operated as a single user station system or a client server system and can be used in various different plants thanks to its modular architecture and scalability SIMATIC BATCH servers can be configured redundantly Basic SIMATIC BATCH components include the Batch Control Center BatchCC used for the operator control and monitoring of the recipe control strategy and the Recipe Editor recipe system used for creating and managing master recipes and library operations Several useful add on packages are available in addition to the basic configuration e ROP Library Managing recipe operations from a central location ensures that changes can be made centrally and that any such changes are passed on to all instances The reference to the master module can be resolved later in the project e Hierarchical Recipe Recipe procedures recipe unit procedures and recipe o
57. P1 HF2 FO 01 01 02_01 04 0002 K7 1 1 2 SIMATIC BATCH Server VF 1 5P1 HF2 FO 01 01 02_01 04 00 02 K 1 1 2 SIMATIC BATCH WinCE Client Options WF1 5P1 HF2 K07 01 01 02_ 01 04 00 02 K 1 1 2 SIMATIC BATCH wt Server Options VF 14 5P1 HF2 KO 01 01 02_01 04 0002 K7 1 1 2 SIMATIC Logon W1 4 5P2 HF1 6O1 04 02 01_01 02 00 01 601 04 02 01 SIMATIC NET PC Software WP 1 5P2 HF4 YVYO R01 02 04 36 46 0001 7 1 2 4 SIMATIC PES 7 Yr7 1 5F1 KU D UD UDO IT KU DI UU SIMATIC PCS 7 Advanced Faceplates WT 5P3 KU DI D30D0 01 29 0007 EO 01 03 00 SIMATIC PCS Advanced Process Library VF 1 5P3 EOF 01 03 00_01 35 00 07 FO 01 03 00 SIMATIC PCS Basis Faceplates We 5P1 EO 01 01 00_01 24 00 07 KU DI UU SIMATIC PCS Basis Library We 4 5P1 kK0r 01 01 00_01 18 00 01 KU DI UU SIMATIC PCS 7 Faceplates WPT 5P1 KU DI DD 01 15 0007 KO DI UU SIMATIC PCS 7 HSF WF 5P1 VO 01 07 00_01 13 00 01 YO 01 07 00 SIMATIC PCS 7 Library We 5P1 k0r7 01 01 00_01 17 00 01 7 1 1 0 SIMATIC PCS 7 PID Tuner WF SPI KU DUDU 07 10 0001 1 1 0 SIMATIC POM VE O 5P5 HF3 606 00 05 03_01 01 00 03 KO6 00 05 03 SIMATIC Route Control Base We 5P1 EOF 01 01 00_01 20 00 02 7 1 1 0 SIMATIC Route Control Blocks We 5P1 EOF 01 01 00_07 20 00 02 7 1 1 0 SIMATIC Route Control Client Yrd SP EOF 01 01 00_01 20 00 02 K7 1 1 0 SIMATIC Route Control Engineering WPT 5P1 EOF 01 01 00_01 20 00 02 F71 1 0 SIMATIC Route Control Faceplate V I 5P1 EOF 01 01 00_01 20 00 02 7 1 1 0 SIMATIC Route Control Getti
58. Plus views e Guest has no rights neither access to StoragePlus views nor to the StoragePlus system It is advisable to assign each user to just one group StoragePlus receives archive data and reports from the OS servers BATCH server via the PCS 7 terminal bus A shared folder called ArchivDir is provided for this purpose where this data is stored by means of file transfer The user who creates a view also has further editing rights for that view This right can also be assigned to other users by means of the administrator console Audit Trail Technically it is not possible to modify data archived in StoragePlus as the StoragePlus Viewer only provides users with read access to the archived data This means that StoragePlus does not support an audit trail in the sense of 21 CFR Part 11 User activities performed in the View Editor and StoragePlus application events are nevertheless recorded in log files e Application log presents the recorded events when archives are connected disconnected for example e Activity log contains events such as changes to the configuration or the publication of views SIMATIC PCS7 V7 1 GMP Engineering Manual 104 A5E02795571 01 Creating Application Software Configuration of the database Ta StoragePlus Administration File Action view Help lt ame Qj StoragePlus 405 Log Viewer System Configuration Server Name LBTS WwINCC Common CG
59. RecordS cccccccccecceceeeeeceeeeeseeeeseecesseeeesaeeeseneeesaaees 2 1 EIS CU Oral SIAO EE 2 8 PGE TA CU 2 9 Reporting DB ALC IUD AU E 20 AONO UGA E 2 11 RR e EE 2 12 Retrieving Archived Data ccccccccscccssseceseseeceseeeseeceseuecesaseeeeaseeesceeseuereneesenseeeens ZNO Time SY MCI tee Ee BEE 2 14 Use of Third Party Components cee cc esses ceeeeeeeeecaeeeeesaeeeeeeaeeeeeeseeeeeeaeeeeessaeees 3 DV SLO NS e e E 3 1 Specification of the System Hardware 3 1 1 Selecting the hardware Components 3 1 2 Hardware specficaton 3 1 3 Hardware solutions for special automation tasks cccccceecceeeeeeeseeeeseeeeceeeeeeaeees 3 2 System and Network Gecuty 3 9 Specification of the Basic Gofbware IST le lt e SV SUC E 3 3 2 Basic software for user administration cee cece ceeeeeceeeeeeeseeeeeeseeeeeesaeeeeesaeeeeeesaees 3 3 3 Engineering system software components ssennssennesrnrrenrrenrrrrernrnrsrnrresnrrennrenne 3 3 4 Operator control level software components senneennenninnennnennnnrrnnnrennrrnnrrneneene SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 T Table of Contents 3 3 5 SIMATIC BATCH basics and Options cccccccccecccceeececeeceeceeesaeeeeseeeesseeeeseneeesaeees 3 4 SIMATIC Additional Software scccnccsnessscrinsiasiocusznennasinnes saphiadesunnnndeieekanidadenbaudetanednseeend SE Zu SINAC PGS 7 add ONS ac cers eceeacesascaren dase ee a
60. VISUAlIZANON ais ee oe ee a 126 VPN EE 45 VAM ee eebe 25 88 122 W WVED CNG AE vedic cei tee ege toate ee 27 SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 A5E02795571D 01 A5E02795571 01 GN 65000 SIMATIC PCS 7 Pharma Siemens AG Industry Sector Industry Automation VMM Pharma 76181 KARLSRUHE GERMANY pharma aud siemens com www siemens com simatic pcs 7
61. a result the Export Picture Objects function must be executed via the dynamic wizard before the changes are passed on this ensures that all objects will be located at their original positions after Import Picture Objects is performed 6 2 Bulk Engineering with the IEA The Import Export Assistant IEA is used for two tasks Duplication with the IEA The Import Export Assistant is used to duplicate process tag types or models This is achieved by defining project dependent typicals on the basis of standard libraries these typicals can then be copied as often as required by using the Import Export Assistant to perform instantiation SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 71 Creating Application Software Note The modular software structure and the process of duplication using the IEA significantly reduce both the risk of errors occurring and the engineering and testing effort required E Shared declarations 4 User blocks create test S i o ao z 7 EE Parameter editing with the IEA Furthermore the IEA File Editor is used to enter parameters and signal processing in a table for each instance in accordance with the definitions contained in the specifications IEA File Editor Assignment of parameters IEA File Editor from first instance Assingment of parameters up to the DIOPEN VALUE E 1 0 D CLOSE VALUE E 1 1 last instan ce to be DO OPEN VALUE A4 1 0 dupl
62. al bus 9 4 3 52 The PCS 7 servers are connected with the clients archive servers and higher level MES systems over the terminal bus The TCP IP protocol is normally used as the transport protocol See also e Manual PCS 7 Compendium Part A chapter 1 3 1 Configuring the terminal bus PROFIBUS Reliable communication with the field level must be in place in order to ensure trouble free plant operation Such communication is based on a high performance real time bus system such as PROFIBUS versions DP and PA See also e System manual SIMATIC NET PROFIBUS Network Manual e Manual PCS 7 Engineering System V7 1 chapter 4 5 6 Fieldbus with PROFIBUS e Manual PCS 7 Compendium Part A chapter 3 4 PROFIBUS settings on the CP 443 5 Ext SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 Project Settings and Definitions Note The configuration of the PROFIBUS devices communication is integrated into the overall project in the SIMATIC Manager A backup of the engineering project therefore contains the entire user software This has corresponding advantages in terms of regular data backups and verification of the software within the framework of the test phases PROFIBUS DP Remote I O stations such as ET 200 can have a simple or a redundant design over electrical or optical PROFIBUS DP networks With the help of an isolating transformer RS 485iS coupler used as a barrier and the intrinsically safe ET 2
63. alled SIMATIC software software tool The tool provides information on the SIMATIC software currently installed on the computer SIMATIC PCS7 V7 1 GMP Engineering Manual 114 A5E02795571 01 Support during Verification KS Installed SIMATIC software Products Components Hii Updates System Files Mame Version Release Release number SIMATIC PCS ZEU W7 1 5F1 YO 01 07 00_07 13 00 01 kr 1 0 1 4AS5 05 Engineering Wo HEA KU DI 000 ID DUU CFC Y7 1 5P1 EOF 01 01 00 07 19 0001 FF71 1 0 DOCPRO VD AA 5P1 K05 04 01 00_01 09 00 01 EA U FORC H E O 1 4 IEAPO Wo HET K0r 01 00 01_01 11 00 02 7 1 0 1 MS Update V1 0 5P1 Y01 00 01 00_01 02 00 01 1 0 1 0 PCS 7 System Documentation ES We 5P1 EO 01 01 00_01 02 00 07 KO DI UU PCS 7 System Documentation Auntine Wiel SP1 F 07 07 07 00_07 02 00 07 KU UU UU PY Inelnfo Server Wi VOF 01 00 00 07 26 0008 YF1 0 0 S PLCSIM Wh4 5P3 HF1 FO05 04 03 01_01 10 0001 EA 3 57 5CL V634 5P5 HF1 6O5 03 05 01_01 02 00 02 K5 3 5 1 Siemens Automation License Manager V40 5P5 E04 00 05 00_01 06 00 01 K4 0 5 0 SIMATIC BATCH Base VWF1 5P1 HF2 KO 01 01 02_01 04 00 02 K 1 1 2 SIMATIC BATCH Blocks WPT SPI EOF 01 07 00 07 06 0001 K7 1 1 0 SIMATIC BATCH Builder WF 1 5P1 HF2 FO 01 01 02_01 04 00 02 E7112 SIMATIC BATCH Client WP1 5P1 HF2 K07 01 01 02_ 01 04 00 02 K 1 1 2 SIMATIC BATCH FastObjects WT SP 1 EOF 01 07 00 07 35 0007 FF1 1 0 SIMATIC BATCH Getting Started WF1 5
64. and units eee Automatisierungsingenteur ES Batch SUPERUSER LGS Betnebsleiter e Nottall Operator GES Operator ei All functions a E atches S ar Formulas Ta General Fa Import E port Fh Libraries ar Materials 4 Process cell ae Recipe Editor ISO Recipes Upoerator U Schichthuhrer ty Cupeuser Verahrensingenieur WIR 4 5 Configuring Access Protection For the general network configuration refer to the manuals PCS 7 Engineering System Configuration and PCS 7 and WinCC Security Concept Since access to the Windows operating system level should be avoided for security reasons additional configuration settings are necessary These settings prevent unauthorized access from SIMATIC PCS 7 process mode to sensitive operating system data Note Access to the operating system level should be limited to administrators or technical maintenance personnel Automatic startup and logon The standard user on the operating system level of each server or client should be logged on automatically during start up Activating the operator control level runtime Automatic starting of the PCS 7 operator control level runtime must be activated so that the operating system level cannot be accessed SIMATIC PCS7 V7 1 GMP Engineering Manual 42 A5E02795571 01 System Installation and Configuration 4 5 1 Configuration settings in Windows The so called hot keys enable access to the operati
65. ans they are suitable candidates for division into several multiprojects the project structure and modes of operation must be carefully planned and documented Your usual Service amp Support contacts would be happy to assist you with this Referenced OS Stations Using a referenced OS station allows you to create a reference to an existing OS station Several OS types can be configured as samples and all other OS stations derived from these samples similar to the way the type instance concept works SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 Project Settings and Definitions Configuration types A reference can be created to one of the two types of OS stations below a Referenced station for OS single user station WinCC application ref b Referenced station for OS client station WinCC application client ref Software configuration using the example of a client The referenced OS client station needs a standard multiclient as a reference A referenced OS client station is then added to the project and the basic OS is defined in the object properties see figure The number of referenced OS client stations is limited by the maximum number of operator stations which is defined by PCS 7 ES TUWY7_05_MP Component view D PCS7 Projects 7 TUWY _OS TUWY_MP Gd TUWY _OS_MP Properties 0S client reference OSC Ref 1 ER TUWV7_OS_Py S ei BN SIMATIC 40001 General OS det reference options
66. archive Database Name _ARCHIVE_O1_ C Advanced H 8 User Managament La View Managament Online Archive Timeframe in days 6 Backup Size in MB 650 Vv onl d au I F long J G immediately after creation cyclic cycle time in hours E fraction of harddisk capacity fract 1 20 a E System event Primary automated store location D StoragePlus D atabase Secondary automated store location Credentials In PCS 7 it is possible to add an archiving identifier at the signal source in the CFC chart or in the process object view of the SIMATIC Manager e No archiving e Archiving short term storage on OS e Long term archiving storage on StoragePlus archive computer If this setting is missing all the Tag Logging data archived and transferred by the OS servers is included Transferring batch reports from SIMATIC BATCH In order to integrate batch reports into StoragePlus long term archiving batch data must be transferred manually on completion of a batch The default setting for this can be found in the SIMATIC BATCH Control Center BCC in Options gt Settings Customize dialog The storage file type must be set to XML on the Archive tab The storage location is the StoragePlus shared folder lt DestinationComputerName gt ArchiveDir Transferring archive data Closed database segments can be transferred manually or automatically Once transferred database segments receive the status
67. at any one time A recipe operation or a recipe phase runs on an equipment module to implement a process engineering task or function recipe phase Control loop The control loop level is not within the scope of the BATCH system and is addressed only via the equipment module It is entirely located in the automation system SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 TT Creating Application Software Application of the ISA 88 01 standard in SIMATIC PCS 7 78 The ISA 88 01 software model divides the process into various modules simplify ing the process of validation and qualification The process is split up hierarchically into the following parts Physical Procedural Implementation in Implemented model elements PCS 7 by Process cell E Pe Procedure BATCH component Operator Sg Da Recipe Srp poten Vp ti i supplier Unit CFC component procedure s Unit block BATCH unit recipes Equipment Recipe SFC type component Supplier Module EM operation Use of SFC types to supported by BESSE allow instantiation operara equipment phases equipment operations may contain control Control CFC component Supplier Module CM Use of the PCS 7 library and of CFC charts Note The names and functions of the modules correspond to the definitions contained in the specifications See also e User manual PCS 7 SIMATIC BATCH e Manual Getting Started PCS 7 SIMATIC BATCH e Manual PCS 7 Co
68. authorization must also be enabled SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 8 4 Operation Maintenance and Servicing Note In a controlled GMP environment many control systems are configured as closed systems or singular solutions Thorough discussions must be held with the plant operator before a remote maintenance functionality is set up Those responsible for the plant must give their express consent for each individual connection to the system logon As NetMeeting is capable of encrypting data transmissions the user should make sure that encryption is activated particularly when sending data via an Internet connection A practical solution could be to assign the logical access permission but to only establish a physical connection when necessary and then only when on site maintenance staff are present System Recovery The procedure described in this section should enable the end user to restore the system after a disaster Disasters are taken to mean the following cases e Damage to the operating system or installed programs e Damage to the system configuration data or configuration data e Loss or damage to runtime data The system is restored using the saved data The backed up data medium and all the materials needed for the restoration basic system loading software documen tation must be saved at the defined point There must be a Disaster Recovery Plan which must be checked on a regular
69. basis Restoring the operating system and installed software The operating system and installed software are restored by loading the corre sponding images see chapter 6 11 Data Backup The instructions provided by the relevant tool manufacturer should be noted If a PC with an identical hardware configuration is not available the installation has to be run again from scratch The documentation that contains descriptions of the installed software and the updates upgrades and hot fixes also installed can be used to qualify the software Restoring the application software The restoration of the application software depends on the system configuration and the type of the backups that have been created e Retrieving data using the Version Trail software Version Trail lists all major and minor version backups including time stamp To retrieve the data the corresponding version is selected and the action started using the de archive button SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 129 Operation Maintenance and Servicing e Retrieving data from a manually created backup version A manually created backup copy can be used e Retrieving recipes e Retrieving archives This applies depending on system configuration and extent of the disorder process data messages batch data log files etc Project specific adaptations Project specific project adaptations that are not stored with the project file must be res
70. be given to event controlled script editing wherever possible as it Saves on resources By contrast cyclic scripts should only be used on a specific basis if necessary SIMATIC Logon must be installed on the Web server thus integrating the Web client into the SIMATIC Logon functions As a result access to the Web client is password protected User rights are assigned in OS user management They correspond to those of standard clients the only additional requirement is that the Intranet Internet access option must be enabled SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 Creating Application Software See also on the topic of information security Chapter 4 6 Information Security e Manual Security Concept PCS 7 and WinCC 6 5 2 Open PCS 7 Open PCS 7 makes PCS 7 data available to higher level systems such as the plant control level The standard interfaces below are available for exchanging data between Open PCS 7 stations e OPC DA Data Access e OPC A amp E Alarm amp Events e OPC HDA Historical Data Access e OPC H A amp E Historical Alarm amp Events e OLE DB for applications with OLE capability such as MS Office products facilitates OLE DB access to historical values alarms and messages via stan dardized database calls The Open PCS 7 station can be used to access several redundant server pairs If a server fails the Open PCS 7 station performs redundancy failover automatically If
71. be simulated Note The use of S7 PLCSIM is of particular interest for the test system e g for typical tests For a subsequent operation with an Ethernet network the Ethernet connection should already be chosen in PLCSIM since in the case of MPI all communication links would have to be reconfigured SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 25 System Specification 3 3 4 Operator control level software components Basic software for operator system OS Systems for the operator control and monitoring of the plant are implemented either as single or multiple station systems With a single station system all operator control and monitoring tasks can be handled on one PC A multiple station system client server architecture consists of operator stations OS clients and one or more OS servers which supply the OS clients with data Redundant systems can be set up to increase availability Note The number of licenses for the operator stations can be increased at a later time using suitable power packs When extending updating a license the existing license must be available i e runtime cannot be active Online extension is only possible for redundant servers OS archiving Process values and messages are stored in a short term archive based on Microsoft SQL server technology The data saved in the short term archive can be moved to long term archives see chapter Setting up process value archive
72. c Versioning in a hidden field within the graphic display Lower graphic Version identification as a visible field within the graphic display explanations relating to the version history outside it rj Graphics Designer PLANT Pdl aie Fie Edit wiew Insert Arrange Tools Window Help Denli tala ala amli ae aaalzz i 2 A T SEU SE OBE L EE Ge EEI e EJI Example for reports EM Report Designer Layout CCOnlineTrendCtrl Curves CP File Edit view Arrange Tools Window Help Deul te c 8 BEA wht mw yf A b QQaa 7vigw been del on d ER EH c Ka SysTime Version 1 0 SysPage al ZE Sa Jot HI oysLayoutName sysProjectName Visible text field for versioning e g in the report footer SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 65 Project Settings and Definitions Example for C VB scripts i Graphics Designer PLANT Pdl qf File Edit wiew Insert Arrange Tools Window Help Deu ssel o ea Fal ema a aaelzz a sa a Creator Max Mustermann lt Object 21BR1 Description Hot water valve TE comment Date New Draw 25 08 2007 Expansion fa Field 26 06 2007 Zoom CE OT aal eej x oli t Event Name Fa 400 100 ie ks Standard Functions a include apdefap h z B Internal functions void OnClick char lpszPictureName char lpszObjectName char loszFropertyName gt 5
73. can be viewed over an Intranet It is not technically possible to modify the data archived by the CAS as the StoragePlus Viewer only provides users with read access to the archived data CAS therefore does not support an audit trail in accordance with 21 CFR Part 11 All events for example the transfer of data to external media or failed transfers are however saved in the log file directory on CAS Process data is initially archived locally in single segments on the PCS 7 OS servers in Tag Logging or Alarm Logging Once a single segment is completed it is copied to the CAS If the CAS has a redundant configuration the single segment is copied to both computers Note The period for single segments on the OS servers in Tag Logging must be configured to be significantly shorter than the period for single segments of the CAS See also e Configuration manual PCS 7 V7 1 Operator Station e Manual PCS 7 Compendium Part A chapters 7 4 4 und 7 4 5 CAS e Product Support http support automation siemens com DE view de 3 7022157 Installation of CAS Long term archiving with StoragePlus StoragePlus consists of three software components e The Administrator Console server application allows the user to assign rights Database settings and backups are also configured here Access should be restricted to an authorized group of people e The StoragePlus View Editor is used to configure trends messages and batch reports whic
74. cennmeiacits po siteheds EEA EENE ERANA 3 4 2 Long term archiving with StOragePIUS cccceecceeceeeeeeceeeeeeeseeeeeseeeeeesaeeeesaeeeeesaaes 3 4 3 Long term archiving with the Central Archive Server CAS 3 5 Application Software Specifications ccccccccccseseceseeeeeeeeeeeesseeeeeeeeeseeesaeeeessaeeeeeeas 3 6 COIS ue DVO n E E O E deen cdeteaccatws SZ ve DK Gil Ee TEE Se en E 303 Images pariton ele EE 4 System Installation and CONnfiguration cccccceeseeeseseeeeeeeeeeeeeeseeeseesneesseeseeeseenseesenens 4 1 Installation of the Operating System cccccecceeeeeeceeeeeeeeeeeeeeaeeeeesseeeeeeseeeeesaeeeeeas 4 2 Ia Lei fei POCS EE 4 3 Setting up User Administration cccccccseeceeceeeeeeeeeeeeeeeeeeeeeeeeseeeseeeeeeeseeeeesaaeeeessaees 4 3 1 User administration on the operating system leVel ccccccceseeeeeseeeeeeeeeeeeeeeeeeeeees 4 3 2 Security settings in Un elle UE Aa SIMATIC ge e e EE 43 4 Configuring SIMATIC LOGOM ME 4 3 5 How ACCESS protection works osscsiseesiesiseedainussced ahecsuos sene teed alek Oued auscdusdedeniuescenaadues eteedetes 4 4 Administration of User Rights 20 0 ee eee rea a eee eee e eee e eee tteeneneaaaaaes 36 4 4 1 Rights management one 36 4 4 2 Rights management on fe 39 4 4 3 Rights management in SIMATIC BATCH 41 4 5 Configuring ACCESS Drotechon 4 5 1 Configuration settings in WWumdows 4 5 2 Configuration setting on SIMATIC PCS CO 453 Sec re
75. cification usually is covered in other separate documents such as a process tag list I O list parameter list P amp l etc The status of these documents version release must be uniquely defined as it must for other specification documents URS FS DS SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 System Specification The SDS includes the following for example e Plant hierarchy e Software structure e Archiving messages trends etc e Module specification possibly in a separate document provided that these have not already been adequately defined in the FS See also e GAMP5 Guide Appendix D3 Configuration and Design Note As a basis for configuring batch control SIMATIC PCS 7 uses the model of ANSI ISA 88 01 see also chapter 6 6 2 Conformity with the ISA 88 01 standard 3 6 Utilities and Drivers 3 6 1 Printer driver It is advisable to use the printer drivers integrated in the operating system and approved for PCS 7 If external drivers are used no guarantee of proper system operation can be provided 3 6 2 Virus scanner The use of virus scanners in process mode runtime is permitted You can find additional information regarding the selection and configuration of virus scanners as well as their updating in the PCS 7 readme files in the product support http support automation siemens com DE view de 2334224 and in the manual PCS 7 Setting up antivirus software When viru
76. ct Editor OS Project Editor E avout a Message configurato E Message display Ger Area Si Runtime window di Basic data p General Curent layout SIMATIC Standard 1044768 Available layouts Layout Description Picture Mame o GE Layout for screen resolution of Ta SIMATIC Server 1024768 ma SIMATIC Server 11527864 Ta SIMATIC Server 128071024 el SIMATIC Server 1600 1200 Gel SIMATIC Serverview 1024768 Ta SIMATIC Serverview 1152 864 Le E SIMATIC Serverview 12801024 Overview extended configuration Detail Gel SIMATIC Getvere 16001200 i ES SIMATIC Standard 1024 768 Runtime Help available Gel SIMATIC Standard 1152 864 cor SIMATIC Standard 1280 1024 Display Gel SIMATIC Standard 1600 7 200 Number of area keys 16 C User name e User ID ass om OF Cancel Apply Another specification made in this Project Editor is whether the user interface should display the user name or the user ID for example See also e Online help of the PCS 7 OS station e Configuration manual PCS 7 Operator Station V7 1 e Manual PCS 7 Compendium Part A chapter 7 1 4 Working with the OS project editor 5 6 Time Synchronization Time synchronization is an important feature in automated systems in the GMP environment When several automation stations AS and or operator stations OS interact messages alarms trends and audit trail data must be archived with synchronized time stamps
77. cted to PROFIBUS DP via the DP FF link This concept offers e Central engineering of the DP FF link and FF field devices without the need for additional tools e FF drivers in the PCS 7 library and the support of the driver wizard e Integration in PCS 7 Asset Management e Cyclic and acyclic communication e Cyclic diagnostic information provided by the DP FF link and the FF field devices See also e Manual DP FF Link SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 55 Project Settings and Definitions Diagnostics with PCS 7 Asset Management A diagnostic symbol is created on the PROFIBUS DP device level in the diagnostic area for each AnyBus DP link It is advisable to insert a status indicator and a button for switching to the user diagnostics of the connected FF field devices for each AnyBus DP link Configuration and diagnostics via the Web interface The connected FF field devices are configured and diagnosed via the supplied web interface 5 5 OS Project Editor The OS Project Editor serves as the basic tool for configuring the user interface for example for setting the screen layout screen resolution etc When an OS project is created in the SIMATIC PCS 7 ES the OS Project Editor is initialized with the default settings Many of these default settings can and should be retained in projects Any devia tions must be defined in the specification and require very special attention in every update of the s
78. ctivated and the activation of the change log file must be defined together with the customer at an early stage Depending on the configuration environment it may be practical to have access protection in place even as early as the configuration phase with the change log file being activated at the start of the FAT Once access protection is configured the additional CPU password can often be done away with if the customer agrees to it 6 9 2 PCS 7 OS Audit Trail in PCS 7 OS SIMATIC PCS 7 records all operations and parameter changes performed in process mode assigning them to the operating messages message class in the message archive Acknowledgments of alarms warnings system messages etc are available in the history of the process control system The figure below shows an extract taken from the operation list Row 24 shows an example for a parameter change The operator Siemens MT changed the mode from 1 to 0 The user ID of the user who is currently logged on can be seen in the overview area 6 operation list GER ZS S7 Programla i2 SIMATIC A17 3 WebP M Acknowledgment PLC process central mes sages System on W Se MS Sit WebP Acknowledgment PLE process control messages oe AUS E E301 WebPhi Acknowledgment PLG process comtrol messages Uap tal WEBO1 WebPht Acknewedginent PLO process central messages System on WEBCL D WEE WBiebbht Acknowledgment PLC process contral messages System on WEBEL WEBI WebPRi Acknowle
79. d from the plant hierarchy of the project by means of their names and priorities copied from the templates and automatically linked to the tag interface of the relevant operator panel Priority Screen name Remark 1 PCS 7Typicals pdl Starting with the picture which comes last alphabetically 2 PCS 7Typicals pdl 3 PCS 7Typicals pd Contained in the standard The PCS 7Typicals pdl template The PCS Typicals pdl picture is included in every PCS 7 OS project by default It contains the standard block icons Note The PCS 7Typicals pdl original file must not be changed under any circumstances Any changes to the original file will be overwritten when an update or upgrade is performed Separate templates should be created for customer specific block PCS 7Typicals pdl See also e Product Support http support automation siemens com DE view de 2669 7820 e Product Support http support automation siemens com DE view de 19688107 Project specific template A project specific template PCS Typicals pdl can be created by copying template PCS Typicals pdl Customer specific changes can then be made to the new template The Template pdl template 70 The Template pdl template is primarily used when block icons are inserted into pictures manually These block icons are not connected to the plant hierarchy and are not therefore created or updated by the system As a result it can be helpful to us
80. dgment PLO process control messages Sistem on WEACL WEEK 1 Weber Acknowledgment PLO process camtral messages Syetem on WEACL WEE WebP M Ac EE on WEBCLO1 WEBO1 WebP hi Ac e en WESBCLO1 WEB WebP hi Ac ent FLC cess Control messages System on WEACL WEBO1 WebP hi Ax edgment PL Control messages System on WEACL WEBI WeboP Ae ee m a SE Suit WebOP Acknowledgment om WEBCLO 743 ES01 WebOF Ackhe Steg on WERCLO OR had ag H Sf Pragram Tie SihMaAtic_4i _2 feb Alt WEE LO 1240700 005 Ordenntegri B atch Ordeninte grl Batch Orderintegri a ator Drder fBatch Username 3 Hisar a bate WEB ft d case comtrol sages System on WEACL Med Tank Wafer Ol W i Titr alak Bieg EEFE I eaage oh WERBCLO Lap iia 2 J T MedHTankii Hale EG EI at CG TEENER ces6 message on ERC oi 2405006 dt LU Fe TI SO N VI MIT Ge ode dute new 1 old zs o Gi EA JE i L U FP T ter Ou Col Tez 1 aly Siamens_MT Medes banal new O ald 1 24S OR Ai OOD LU FG TRIE Ter Out Col Te liWalve Siemens MT Meade Suc phew 1 sid 0 ZAG H Ab 20 DD H UF TGilxter Ou Col Tei Tivalve Siemens_MT Mede hlanual new ald 1 24S 0645 35 000 LUF TE2 xfer Out Culley TEZ 4 Waly Sieamans_MT Valve Opennew 1 old O KA O66 000 U FAD Teak fer_ Out Coley _ Th 1 faly Slemens MT Valve Close new 0 old t SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 89 Creating Application Software Notes If parameter changes are made via input output fields message output must be configured s
81. djustment is set correctly in the operating system If a SICLOCK is used as the timer and the operator station display is adjusted to daylight saving time the SICLOCK must also be configured to daylight saving time to ensure that all messages are archived with the correct time stamps This adjustment must be activated on the operator station in the Control Panel gt Date and Time gt Time Zone tab See also e Function manual PCS 7 Time Synchronization e Configuration manual PCS 7 Engineering System chapter Configuring time synchronization e Configuration manual PCS 7 Operator Station chapter Time of day synchronization SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 9 7 Project Settings and Definitions e Manual Security Concept PCS 7 and WinCC e Manual PCS 7 Compendium Part A chapter 7 1 7 Time synchronization e Product Support http support automation siemens com DE view de 19693801 DCF77 e Product Support http support automation siemens com DE view de 16622135 Industrial Ethernet e Product Support http support automation siemens com DE view de 16620294 Windows Domains e Product Support http support automation siemens com DE view de 16622902 Settings e FDA Guidance 21 CFR Part 11 Time Stamps 2002 withdrawn Configuration Management The configuration of a process control system consists of various hardware and software components which may be of varying complexity
82. duction delays and the available reaction time e g lt 5 minutes 5 20 minutes gt 20 minutes The priority is defined on an instance specific basis in PCS 7 during message configuration and is initially set to 0 PCS Message Configuration B_Prj Automation System CPU 41 7 4 Program Blocks FB61 Last changed 17 11 2003 10 23 16 Display language Deutsch Message identi Message class Bl Priority FT Eve EE Alarm above ira j ae eters Warning above SE Warning below PSE Aerm below i s65 PLC Process Control Message Failure SIE Alarm above O00000 L aes Alar below 7 PM BlockComment zu hoc TC PM 8BlockComment hoch TIP BlockComment tiet TC PM 8BlockComment zu tiet C BlockComment Fehler exter C ER 3BlockComment zu hock TC ER BlockComment zu et LE Glastztaftasd j TO Message Cancel Help It is preferable for the priorities to be set in the process object view SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 83 Creating Application Software 6 8 4 Suppressing filtering hiding Disabling messages When the appropriate permission is granted in process mode the plant operator is able to set individual process tags to the out of service status thus suppressing all messages of this process tag This function is used for example if a process tag is being used for the first time The operat
83. dustrial Ethernet og TH ET 200M IO card poss measuring transducer J Field Ka Sensor SE WE The process values and messages saved in the OS server can be transferred to the archive server for long term archiving Accumulated batch data and reports can also be passed on to the archive server by the BATCH server Note If the connection to the archive server is interrupted the data is buffered in the short term archive of the station concerned The size of the database is determined by the number of process value archives and the process tags they contain The size of each process value archive de pends on the measurement with the fastest acquisition cycle Cycle acquisition should be performed uniformly within a process value archive It is therefore advisable to always store process tags with the same acquisition cycle e g 500 ms 1s 10 s 1 min together in one process value archive As a result a separate process value archive is configured for each acquisition cycle Archiving cycles are specified in the process object view see figure SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 Creating Application Software EA SIMATIC Manager Color Process Object View D Projekte olor Color E File Edit Insert PLC Yiew Options Window e ERRELE TLE AE S Em Color es E Color Pa eo General Blocks Parameters Signals Messages Picture objects gf Archive tags Hierarchy Folder
84. e naannnnennnnnennenennnesnnnnennnennnnne 7 3 2 Verification Of software Droducls 7 3 3 Verification of the application software eee eeeee eee etteeaaeeeeey 117 7 3 4 Simulation for test mode cccceccccsssececceseeecceeeeeeceseeecseueeecseeeeeseageeeesegeeesssaeeeenes 1 4 Configuration Control 7 4 1 Versioning Projects with Version Tra 7 4 2 Version comparison with Version Cross Manager VXM 7 4 3 Write protection for CFC SFC charts and SFC wpes ccc ecccceeceeeeeeeeeeeeeeeeeeeees 8 Operation Maintenance and Servicing ccccceseeeseeseeeeesseeeeeesneeesneseeesenneeseaeneesoees 8 1 Operation and MONMONING WEE SA Process VISUAIIZAU O EE Clee AS emage men nu a a a 126 Sz Regular Data BackUPS E 8 2 Change Control during Operation 8 3 Remote Maintenance 8 4 VSE ROCOV an E EEE EE E A E E 9 System Updates and Migration ccccsscccesseseeseseeeeeeeseeeseeseeeseesneeeseneeseoeeeeesensneesenees 9 1 Updates and Service Hacks 9 2 OUR e EE MOEN LIS rena a E E E E E fenwecaeveccus edsaenenesenecsss SIMATIC PCS7 V7 1 GMP Engineering Manual 10 A5E02795571 01 1 1 1 2 Configuring in a GMP Environment Configuring in a GMP Environment Before configuring computer systems in a GMP environment approved specifica tions must be available Requirements contained in standards recommendations and guidelines must be observed when creating these specifications and when implementing and operating
85. e button for exiting process operation deactivate OS can only be clicked if the appropriate permission is available SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 43 System Installation and Configuration 4 5 3 4 6 4 6 1 4 6 2 Firewall 44 Secure configuration If possible no OLE objects should be configured as such objects often allow unauthorized access to folders files and programs Information Security SIMATIC Security Control SSC Using SIMATIC Security Control increases the level of computer security The application can be run either when PCS 7 installation is completed or at a later point in time The following settings are configured automatically for specific functions OS client server ES etc e Configuration of the Windows Firewall exception list for PCS 7 communication firewall can be activated e DCOM settings for PCS 7 Distributed Component Object Model e Security related registry entries Following installation the Start gt SIMATIC gt SimaticSecurityControl menu com mand can be used to perform configuration at any time SSC also enables the settings made in the system to be documented Note If the SIMATIC PC station is integrated into a different working environment domain or workgroup it must be reconfigured SCALANCE S The increasing integration of plant networks into office networks brings with it a rise in associated security risks from network problems
86. e functions integrated in SIMATIC PCS 7 The maintenance engineers access to all details of the components and devices when needed beginning with an overview display plant view The overview display uses the standardized symbols to visualize the condition of a component itself and also provides collective information on the conditions of all devices in the lower level hierarchies The group status message shows the OK condition or the seriousness of a possible problem in red yellow or green similar to a traffic light In the diagnostic faceplate a monitored component can request maintenance services The status of the work can also be specified This is recorded in the form of an operating message and indicated by the symbols A work instruction number and a comment can be entered for each work request SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 Operation Maintenance and Servicing A report can be printed out for each component SIMATIC Asset Report Copyright Ge 1994 2007 by SIEMENS AG Tag Status Description Message Device tbe Manufacturer Order Number Serial number Install date Hiv Revision GMP Manual SIPART PS2 PA 120039 01 07 2001 FAG amp LP ov Revision 5 00 00 00 E1 Demand Note WE Date Ewent 1209007 13 15 10 Device 242 good maintenance need Request number Request Operator POM Diagnose POM Diagnose POM Diagnose POM Diagnose POM Diagnose E513 gi 22007 11 20 54 A
87. e project administrator That user can then define other users as project editors or project administrators To com plete activation of access protection the user must specify a project password which should only be known to the project administrators SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 System Installation and Configuration Activation of Access When project node is selected choose menu Protection Options gt Access Protection gt Activate The Windows user who activates access protection via Logon Service is automatically defined as project administrator Logon via SIMATIC Logon Service Definition of After successful logon at SIMATIC Logon the project administrator defines the project password Project Password Finished SIMATIC Logon Role Management serves as the interface for assigning users to the group of project editors or project administrators Notes Access protection must be activated for every project and every library used in the multiproject Synchronization Within a multiproject access protection for one project or library can be passed down to all other projects libraries The project format is changed when access protection is activated for the first time The project can then no longer be edited using a STEP 7 version lt V5 4 Possible user permissions on the ES A user on the ES may be given the following permissions Project editor e Make project change
88. e the template file On the one hand you are not then linked to the plant hierarchy and on the other hand you can use a wizard to export picture objects from one or all flow charts to a configuration file modify block icons and their connections and finally import the picture objects again The configuration file can be edited using tools such as Excel SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 Creating Application Software Note The Template pdl file is maintained by the PCS 7 system and is overwritten when an update or upgrade is performed It is therefore advisable to back up the Template pdl file on a regular basis Other Template Pictures Config Typicals pdl Used to create update lifebeat monitoring MaintenanceT ypicals pdl Used to create update diagnostic pictures pcs elements pdl The template contains a collection of predefined objects for creating faceplates PCS 7 Typicals_Batch pdl Used to create update block icons for SIMATIC BATCH PCS 7Typicalsrc pdl Used to create update block icons for SIMATIC Route Control This list is not exhaustive Central changeability of picture objects In the type definition SIMATIC PCS 7 allows objects to be changed centrally in other words subsequent changes to picture objects are made in the template pictures Note The central changeability of picture objects does not mean that changes are automatically passed on down to the instances As
89. e to be used within a computer system in lieu of handwrit ten signatures certain legal regulations such as those contained in 21 CFR Part 11 of the US Food and Drug Administration must be complied with Other laws and regulations define the actions for which signatures are required The process owner is always the one who decides which of these signatures can be provided electronically 6 10 1 Electronic signatures in SIMATIC BATCH If SIMATIC Logon is installed an Electronic Signature package will also be available whose basic function is to enable electronic signatures to be used in SIMATIC BATCH The figure below shows the Properties dialog window for configuring electronic signatures Two electronic signatures are required in this example they are specified in the configured roles box in the SIMATIC BATCH Recipe Editor SIMATIC PCS7 V7 1 GMP Engineering Manual 92 A5E02795571 01 Creating Application Software Properties of Dryer Se x ES General H Allocations ih Product d Input material SCH Output material adi Parameters Le Transfer parameter EL Dependencies 3 Process tags P Change log CH ESIS E Activate configured roles CS Operator ee Shift manager en 1 pe The project settings can also be used to make an electronic signature necessary for releasing recipes parameter sets formulas and recipe operations etc Project settings for GP bp 3 Fa General Warnings
90. eans of their name version number etc This description serves as a reference when performing subsequent tests FAT SAT IQ OQ Commercially available standard software components include automation soft ware components and software provided by third parties see also chapter 7 3 Verification of Software SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 23 System Specification 3 3 1 Operating system Information regarding the operating system installation can be found in the latest PCS 7 PC Configuration and Authorization manual Information on hardware and software requirements is also provided in the readme file on the PCS 7 Toolset DVD 3 3 2 Basic software for user administration Access to the SIMATIC PCS 7 system components is controlled via SIMATIC Logon More information on the installation and configuration of the various SIMATIC Logon components can be found in chapter 4 3 Setting up User and in the configuration manual for SIMATIC Logon 3 3 3 Engineering system software components Some of the most important functions of the SIMATIC PCS 7 engineering software are described below Multiproject engineering See chapter 5 1 Multiproject Setup for information on how multiprojects are set up and used Process control libraries The process control libraries contain ready made tested objects blocks face plates and symbols When these libraries are used engineering is usually limited to t
91. ect access protected TOW Lib i Press F1 to get Help DC internal tlocali If the user attempts to open the project he will be prompted to enter the project password If the user knows this password and enters it he is automatically defined as a project administrator Recommendation The project password should only be known to the project administrator SIMATIC PCS7 V7 1 GMP Engineering Manual 38 A5E02795571 01 Scenario 3 4 4 2 System Installation and Configuration e SIMATIC Logon not installed If SIMATIC Logon is not installed there is no project administration function Each time a protected project library is opened the project password must be entered Also in this case the project password should only be known by the relevant group of people If the protected project has been provided by a customer they must decide whether or not the existing password should be changed in their system Recommendation The way in which the project password is used and the time at which access protection is to be activated on the ES level should be given careful consideration and defined at an early stage See also e Configuration manual PCS 7 Engineering System Rights management on the OS Windows user groups are assigned to PCS 7 OS groups by creating groups of the same names For example if you want to assign an Operator Windows group an identically named Operator group must be created in the PCS 7
92. ectronic signature cceeceeeeeeeeeeeees 17 92 EE Ee 95 PCS OSes Aa ese ee ee 94 SIMATIC BAT CR eege Sien 92 SIMA TIC LOGO e E 92 Engineering system cccceeeeeeeeeeeeeeeeeeeeees 24 E FPDA2ZTOFR Pam Tirai 11 17 86 SHEET 232 era a EA tus 44 Foundation Fieldbus ccccceeeeeeceeeeseeeeeeeee 55 G AVP EEN 11 SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 Index List H Hardware Category EEN 14 Hardware Specification cccccceececeeeeeeeeees 21 POET chains Shula oncocutes sae uadecunt e laa eaitest 131 Mage EE 30 95 129 Import Export Assistant 00000aaaan 25 60 71 Industrial Ethernet naaenennnennnennnnennnrnnnnne 52 Information security cccceecceeeeeeeeeeeeees 23 44 le Ee WEE EN Installed software ssc0cncienoni ENNEN 114 ie Eh EEN 29 77 L MORAN EE 24 47 Life Cycle model 11 Lifebeat Monttorng 85 102 M Maintenance EE 126 Master data Ibranm 47 Message CIASS ccccceseceeseeecssseetseeeseueeseuees 83 Migran EE 132 MUITIDFO C GE 46 O ORO ee 26 Open EE 26 75 Operating system ccccceececeeeeseeeeeeeeeeeaeees 24 Operator EE 26 D PACKAGS WINE EE 58 So te ie EE 30 Hassword 16 Password polces 33 PCS 7 AGO EE 28 PCS FOS EE 74 Plant hierarchy EN 50 Printer driver 29 Process pictures uin ee RY S 73 Process tag Iwpe 68 Selen IER LEE 52 R Recipe control strategy 76 Referenced OS station 46 133 Index
93. ed if the associated Time period for all segments or Max size of all segments parameter is exceeded SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 101 Creating Application Software A SIMATIC Manager Color Component view D Projekte Color Color File Edit Insert PLC View Options Window Help D sie BA gg Se By a ii Se ZI NoFiteis y P Color i Properties OS CAS _OS 11 Ep Color_Pr RB AS400 Q AD044289NB B cas H WinCC CAS Application General Target0S CAS Options for the central archive server A T agLogging Fast TagLoaging Slow AlarmLogging e Report Iw E f ei Cc Open Object i Archive size Cut Time period of all segments 10 Day s X Co ei De Max size of all segments 5 Gigabyte s D Delete Time period covered by a single segment 1 Date v PLC Max size of a single segment DUU Megabyte s v Access Protection Color_Lib Display load log Time of the first segment change Generate server data Month Febuay SS ee EE Print Weekday i ngay Hour o0 Minute 0 Rename Object Properties Alt R Iw Only long term data Signing activated Backup activated E Backi M Destination path Alternative destination path Displays properties of the selected object for editing Other activities relating to the destination paths creation of server data packages start and execution of the Project Editor
94. edures must be tested to ensure that data is saved correctly Backup records should be labeled clearly and intelligibly and dated Backups are created on external media The data media used should comply with the recommendations of the device manufacturer When backing up electronic data the following distinctions are made e Backup of the installation for example partition image e Backup of the application e Backup of archive data for example process data Here particular attention is paid to the storage of data backup media storage of the copy and original in different locations protection from magnetic fields and natural hazards Retrieving Archived Data Archived backed up data must be retrievable at all times If the system is updated care must be taken that the data transferred to archive prior to the update remains compatible 1 Good Practice and Compliance for Electronic Records and Signatures Part 1 Good Electronic Records Management ISPE PDA 2001 Good Practice and Compliance for Electronic Records and Signatures Part 3 Models for Systems Implementation and Evolution PDA 2004 Electronic Records and Electronic Signatures Assessment Chris Ride amp Barbara Mullendore PDA 2001 SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 19 Requirements of Computer Systems in a GMP Environment 2 13 2 14 20 Time Synchronization A uniform time reference including a time zone reference mus
95. eering Manual A5E02795571 01 2 6 2 7 Requirements of Computer Systems in a GMP Environment Requirements of Electronic Records When using electronic records for relevant data the following requirements apply e The system must be validated e Only authorized persons must be able to enter or change data access protection e Changes to data or deletions must be recorded audit trail e Relevant electronic records for long term storage must be archived securely and kept available for their retention period e The initials and signatures required by the regulations must be implemented as electronic signatures e Relevant production steps processes significant interim stages and major equipment must be defined in advance by the person responsible from a pharmaceutical perspective this definition is often process specific e If an electronic manufacturing log is used its structure and contents must match the structure and contents of the manufacturing formula processing instructions As an alternative the manufacturing instructions and log can also be combined in one document See also e EU GMP Guidelines chapter4 9 e 21 CFR Part 11 Electronic Records Electronic Signatures Electronic Signatures An electronic signature is computer generated information that acts as the legally binding equivalent of a handwritten signature Regulations concerning the use of electronic signatures are defined for exam
96. els 2 B Automatically resolve excess substructures Allow simultaneous ROPS Allow editing of recipes with Release revoked status Allow online setpoint change Transfer online setpoint change to active step JUnit selection according to conditions Additional settings in SIMATIC BATCH 6 6 4 Important parameters and settings can also be found in e Chapter 6 9 3 on the topics of audit trail and change control e Chapter Electronic signatures in SIMATIC BATCH Creating batch reports SIMATIC BATCH enables the output of reports based on prefabricated report templates from Crystal Reports You additionally need the full version of Crystal Reports for a customized report design BATCH Advanced Report and SQL server must be installed on the server for this Unless the SIMATIC BATCH component SBReport is used to display archived batch reports format V7 0 must be used for archiving This setting is made in the project settings of the Archive tab see chapter 6 12 3 Archiving batch data SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 81 Creating Application Software 6 7 6 8 6 8 1 82 SIMATIC Route Control SIMATIC Route Control is the secure automated transport of materials Typical application examples include e Transport of solids and liquids e Buffer applications and provision of buffers for production e Bio reactors such as cell culture plants with upstream and downstream e CIP a
97. eparately Select the hard disk capacity so that the entire audit trail can be stored there until it is transferred to an external data medium Change control for the OS configuration and OS project engineering The OS configuration as well as the project engineering of OS elements pictures scripts etc is versioned on the ES and archived together with the overall project SIMATIC Version Trail Changes made to individual OS elements must be controlled in accordance with the applicable change procedure since initial release 6 9 3 SIMATIC BATCH Audit Trail in SIMATIC BATCH Operator actions performed in SIMATIC BATCH are recorded in the same mes sage archive as OS operator actions see above A batch report containing information on the operations performed for each batch who when what is also created in SIMATIC BATCH Change control for recipes and batch objects Changes made to recipe data and batch data deleted batches for example are logged in the change log The user time and action are entered in this log To ensure consistent version management the following project settings must be made e System aided versioning option selected Project settings for DEMO6_HF Used Plug in Modules Electronic signatures General Color Font Archive versioning E Free versioning Preset version vrO Preset versioni Cancel Help SIMATIC PCS7 V7 1 GMP Engineering Manual 90 A5E0279
98. ependent alarm suppression e g suppression of flow monitoring if a pump is switched off These points must be defined if they deviate from standard specifications The default standards for displaying message classes colors and priorities must be retained if possible and should only be changed upon customer request SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 6 8 2 6 8 3 Creating Application Software Note If the alarm system configuration differs from the standard configuration the differences must be documented and an update procedure described see also chapter 9 ystem Updates and Migration See also e Manual PCS 7 Compendium Part A chapter 5 1 4 Changing the message class priority and message text Message classes The different message classes such as fault alarm warning or process control message are usually defined on a function and event specific basis For example if a measurement is taken reaching the high limits will trigger an alarm the low limits a warning and a runtime error on a valve for example will trigger a fault message See also e Manual PCS 7 Compendium Part A Chapter 7 3 1 Message classes and message types Priorities To ensure that the plant operator can still perform actions even in critical situations messages can be additionally prioritized in PCS 7 in accordance with their possible effect plant standstill reduction in product quality or pro
99. eports SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 11 Configuring in a GMP Environment Planning Reporting Configuration and or Coding Supporting Processes including Risk Management The lifecycle approach illustrated here is known as the generic model in GAMP5 With this as the basis several examples of lifecycle models for a variety of critical systems with different stages of specification and verification phases are shown as examples Once production has started the system life cycle continues until the product is taken out of service Siemens Validation Manual 1 3 12 Siemens has produced a Validation Manual based on the recommendations of the GAMP Guide This provides internal project teams with general information and concrete templates to help specify the validation strategy for a project There are templates not only for project planning documents but also for system specification and test documentation In contrast to this GMP manual the Siemens Validation Manual is intended for internal Siemens use only Responsibilities Responsibilities for the activities included in the individual life cycle phases must be defined when configuring computer systems in a GMP environment and creating relevant specifications As this definition is usually laid down specific to a customer and project and requires a contractual agreement it is recommended to integrate the definition in the quality and project
100. eset again Audit policies 4 3 3 34 The security mechanisms for audit policies relating to logon attempts account management activities etc are set in the operating system Guideline si Description of security setting Audit logon attempts Specifies whether or not the instance of a user logging on to a computer is audited Audit account Specifies whether or not the individual events of account management management are audited creating or changing a user account changing or setting passwords Audit logon events Specifies whether each instance of a user who has logged onto or logged off a computer will be audited Audit policy change Specifies whether or not changes to user rights policies audit policies or trust policies are to be audited Note In order to enable logon activities to be traced at a later date the required settings must be made in the audit policy of the local Di icies of Window as well as those in SIMATIC Logon as described in chapter 4 3 4 Configuring SIMATIC Logon Configuring SIMATIC Logon Logon SIMATIC user groups When PCS 7 is installed default SIMATIC user groups are automatically created in the operating system SIMATIC HMI etc These must not be changed or deleted See also e Manual Security Concept PCS 7 and WinCC SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 4 3 4 System Installation and Configuration Note The defined users and user groups
101. figured using the Advanced PC Configuration procedure With Windows all the automation stations AS and operator stations OS can be configured on a central engineering station and the configuration files can be downloaded Specifically the following connections are configured SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 51 Project Settngs and Defnitons n 5 4 2 e AS OS connections e AS AS connections e ES AS connections e Remote I O connections These connections can also be designed to be fault tolerant More information can be found in the SIMATIC NET documentation Plant bus and terminal bus Industrial Ethernet offers a comprehensive range of network components for electrical and optical data transmission In SIMATIC PCS 7 a distinction is made between a plant bus and a terminal bus To guarantee a high degree of security and performance it is advisable to install these two buses separately Industrial Ethernet plant bus Industrial Ethernet is used as the plant bus The Industrial Ethernet network operates according to the access method CSMA CD Carrier sense multiple access with collision detection as defined in IEEE 802 3 The automation stations are connected with the OS servers and the engineering station over the plant bus The ISO protocol is generally used as the transport protocol See also e Manual PCS 7 Compendium Part A chapter 1 3 2 Configuring the plant bus Ethernet termin
102. from standard com ponents through to specially customized user components A clear and complete overview of the current system configuration must always be available This is achieved by dividing the system into configuration elements which can be identi fied by a unique designation and a version number and can be distinguished from the previous version Defining configuration elements In terms of hardware standard components are usually used which are defined by and documented with their type designation version number etc If customer specific hardware is used more work is required see chapter 3 1 pecification of the System Hardware System Hardware for more on this Such standard components are used at least in part for the software for example SIMATIC PCS 7 system software its libraries and add ons Just like the hardware these are defined and documented with designation version number etc User software is configured and programmed on the basis of standard software It is not possible to give a blanket definition of the individual configuration elements which the user software must be divided into due to differing customer require ments and system designs Versioning of configuration elements Although users project engineers cannot modify the version ID of standard soft ware application software configuration calls for work instructions which specify among other things the assignment of version numbers and a
103. ge required Basic knowledge about SIMATIC PCS 7 is required to understand this manual Knowledge of GMP as practiced in the pharmaceutical industry is also an advan tage Disclaimer of liability This manual contains instructions for system users and project engineers for integrating SIMATIC PCS 7 process control systems into the GMP environment It covers validation and takes into account special aspects such as the requirements of FDA 21 CFR Part 11 of the American Food and Drug Administration We have verified that the contents of this document correspond to the hardware and software described However since deviations cannot be precluded entirely we cannot guarantee full consistency The information in this document is checked regularly for system changes or changes to the regulations of the various organiza tions and necessary corrections will be included in subsequent issues We wel come any suggestions for improvement and ask that they be sent to the IA VMM Pharma in Karlsruhe Germany SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 3 Introduction Validity of the manual The information in this manual applies to SIMATIC PCS 7 V7 1 including SP1 The components examined are the PCS 7 ES PCS 7 OS SIMATIC BATCH as well as the Central Archive Server and StoragePlus add ons Refer to the CA01 catalog for detailed information on the compatibility of the individual components The catalog can be ordered over the I
104. ghing modules SIWAREX e Integration of frequency inverters for drives Masterdrives Micromaster etc e Integration of user specific field devices To keep validation work to a minimum hardware components from the PCS 7 add on catalog ST PCS 7 A should be given preference System and Network Security In the field of modern process control systems the boundaries between the office and automation environments are disappearing at an ever increasing rate Automation solutions linked to WEB clients MES applications and customer specific office networks and applications are gaining in importance To satisfy these demands and ensure as high a level of data security as possible the planning and structure of networked PCS 7 automation solutions are highly important See also e Manual Security Concept PCS 7 and WinCC Opportunities for improving plant security 3 3 PCS 7 offers several ways to improve information security within a plant These include e Staggered user group and role concept e SIMATIC Security Control SSC e SCALANCE S firewall and VPN modules For more information see chapter 4 6 Information Security Specification of the Basic Software The Software Design Specification acronym SDS describes the software s architecture and configuration It includes a description of the application software as well as a definition of the standard software components used in the system which are specified by m
105. h AS in the form of a document containing software version details The SIMATIC PCS 7 type instance concept enables types of sequential controls to be created The SFC type allows sequential controls to be defined including an interface in the form of a CFC block The sequence logic of the SFC type is based on the interface I Os of the SFC type i e in contrast to an SFC chart an SFC type cannot access just any process signals More detailed information on this topic can be found in the manual SFC for SIMATIC S7 The SFC type is not executable on its own An SFC type just like a function block type must be placed in a CFC chart before it receives an executable object in this case an SFC instance The SFC type and SFC instances are compiled when the program is compiled To execute an SFC instance both the SFC type and the SFC instance are downloaded to the automation system Process tag type model 68 With SIMATIC PCS 7 a process tag type model consisting of one or more CFC and or SFC charts can be created for subcomponents of the same type Creating process tag types or models for similar plant units saves on work required for engineering and testing Once a process tag type or model has been tested it can quickly be duplicated as often as required in the multiproject in the form of replicas For each replica the plant hierarchy CFC name messages I Os for parameters or signals and various module properties can be adapted
106. h are saved in a separate view e The StoragePlus WebViewer is used to display views that are produced using the View Editor and have been published for this form of viewing SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 103 Creating Application Software Operating principle StoragePlus collects completed archive data segments from the servers together in a separate database according to chronological criteria so that they can be transferred to CD or DVD when a certain user defined size is reached The database segments that result from the StoragePlus archiving procedure have the status connected which changes to disconnected when they are trans ferred For StoragePlus to display archive values the database segments must be connected Archive data that has already been transferred can be connected to the Storage Plus database again The Catalog call integrated in the administrator console in StoragePlus provides an overview of the current status of the database segments Installation StoragePlus is based on the MS SQL server The installation instructions include detailed information on the installation order which must be followed and on the selection of partitions Access protection The following default user groups exist in the StoragePlus administrator console e Administrator full access to the StoragePlus system e Power user can read and create StoragePlus views e User can read Storage
107. h has the disadvantage that the batch automatically applies and enables the changes when the changes are made Notes and restrictions e When online structure changes are being made to a batch access to this batch by other clients is blocked A visual comparison of the changes to all Batch clients is made once the online structure changes are completed e Existing conditions within a transition cannot be deleted e During the online structure change parameters and their data type cannot be changed e During the online structure change unit candidates cannot be changed e During the online structure change process tags trend recordings cannot be changed e tis advisable to stop the batch for structural changes If a structural change is made without stopping the batch a complete log cannot be ensured SIMATIC PCS7 V7 1 GMP Engineering Manual 80 A5E02795571 01 Creating Application Software Deleting a canceled batch Particular attention should also be paid to the point Allow deleting of completed unarchived batches for example This is only rarely desired in the pharmaceutical environment this setting should therefore be declined unless the customer expressly states otherwise see figure below where the option is still selected Project settings for DEMO _MP Used Plug in Modules Report Electronic signatures General Warnings Color Font Archive versioning Max number of substructure lev
108. hardware and spare parts For reasons of system availability and data security integrity appropriate class RAID systems for PC components such as ES OS single stations OS servers and BATCH servers should be implemented in the system design When a SIMATIC PCS 7 bundle is supplied the customer receives a PC with all software required for the relevant applications installed The components contained in the bundle are not always identical to the products of the same names available on the market As a consequence the availability of spare parts will differ too Recommendation Only released hardware from the current PCS 7 catalog should be used the use of unreleased configurations results in additional work for specification and qualification being required www siemens com automation ca01 SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 21 System Specification 22 Note If PCs are placed in control cabinets make sure that provision is made for the use of suitable hardware components such as operator channel extensions There are different types of automation systems e Standard automation system e Fault tolerant automation system The user programs loaded in both CPUs are fully identical and are run syn chronously by both CPUs The failover has no effect on the ongoing process because it is bumpless e Fail safe automation system Such systems automatically bring the plant to a safe state in the event of a fault
109. he configuration of the relevant objects One major advantage of using prede fined objects when project engineering automated systems in the harmaceutical industry is the lower level software categorization see chapter l Software and the possibility of implementing updates Therefore the validation work required is less than that for user specific blocks CFC Continuous Function Chart The CFC editor provides a graphic interface for configuring automation and control functions Drag amp drop is used to move function blocks from libraries to a CFC chart where they are interconnected and configured in accordance with require ments SFC Sequential Function Chart The SFC Editor facilitates the graphic configuration and commissioning of sequen tial controls The most important components are steps and transitions as well as simultaneous and alternative branches SIMATIC PCS7 V7 1 GMP Engineering Manual 24 A5E02795571 01 System Specification Import Export Assistant The Import Export Assistant is a tool used to configure systems which feature recurring functions and or plant units Process tag lists or CAD charts previously created in the planning phase are used during configuration to create CFC charts for process tags for the most part automatically During this process replicas of the modules are generated and then supplied with specific data For more information on the configuration and use of the IEA see chapter 6
110. he time from OS servers whose server data they have also loaded Time synchronization in a Windows domain If the automation system is operated in a Windows domain the domain controller with the PDC role serves as the time master on the terminal bus It obtains its time from a SICLOCK connected in series for example The OS servers receive the time from this domain controller via the terminal bus The OS clients obtain the time from a selected OS sever The plant bus and as a result the connected automa tion stations AS are also synchronized by this OS server the first server to enter process mode The server then becomes the active time master When high precision time stamping is required the automation stations also have to be synchronized directly by a SICLOCK TM via the plant bus If the plant uses components such as BATCH servers on which no operator station is installed these also need to be synchronized This can be done via an additional DCF77 or GPS service or by means of software over the network or the Internet Time synchronization for package units 58 Package units may be integrated in many PCS 7 environments These package units can obtain their time from the Windows domain through the standardized Network Time Protocol NTP It is also possible to send the time signal from one Siemens Automation system to another via the S7 protocol Notes It must be ensured that the automatic daylight saving standard time a
111. iatar JHT bhia ECLER an a e Note Logons logoffs and unsuccessful logon attempts can be viewed in the SIMATIC Logon Eventlog Viewer and exported changes to the user and group configuration are recorded on the operating system level SIMATIC PCS7 V7 1 GMP Engineering Manual 32 A5E02795571 01 4 3 2 System Installation and Configuration Security settings in Windows The following information is based on Windows 2000 server Local Security Settings File Sacer Se Hep 7 Biz eg Poly e Security Setting Security Settings CR Account Policies Sea Enforce password history D passwords remembered a Be Password Policy ZF Maximum password age 90 days Ce FREE el Minimum password age 1 days Go d SC e Fa Minimum password length 8 characters H 2 meg ae peat D Za Password must meet complexity requirements Enabled Software Restriction Policie EF store password using reversible encryption For all users in the domain Disabled IP Security Policies on Loca Note Following Windows installation default parameters are set for the password policies account lockout policies and audit policies The settings must be checked and adapted to the requirements of the current project Password policies The password policy security settings are made in the operating system Guideline Description of security setting Enforce password Specifies the number of explicitly new passwords that must
112. icated Instantiation DI OPEN VALUE E 50 0 DI_CLOSE VALUE E 50 1 DO OPEN VALUE A 50 0 SIMATIC PCS7 V7 1 GMP Engineering Manual 72 A5E02795571 01 6 3 6 4 Creating Application Software Note The Import Export Assistant is managed as a separate add on package in SIMATIC PCS 7 It is included on the PCS 7 Toolset DVD and installed as part of the general setup although it does require a separate license See also e Manual PCS 7 Engineering System V7 1 chapter 8 11 7 Creating process tags from process tag types multiproject Creating Process Diagrams See chapter 6 1 3 Automatic generation of block icons to learn how to use templates as a library for graphic typicals Process diagrams must be created in accordance with the definitions contained in the specifications e g URS FS and P amp l Block icons should be assigned using the automatic generation of block icons function i e one block icon is assigned to each instance specific module valve pump closed loop controller etc in the process picture using the IEA file The picture and the block charts must be configured in the same plant hierarchy folder or in plant hierarchy folders with the same name in order for block icons to be generated After the graphics are created they should be submitted to the customer in the form of screen shots for approval See also e Manual PCS 7 Compendium Part A chapter 7 2 Visualization interface
113. ie Product d material ay Output material SEI Parameters Di Transfer parameter By Dependencies Process tags E Change log ESI List _ Date Processedby Action Computer name 1 2008 01 30 16 55 4 Workshop User Creates name Workshop version 1 0 1D AD0S0119MB 2 2008 01 30 16 56 5 Workshop User edited ADOSO119NB 5 SE SE Ka edited KEE EE e Ce SE SE KE EE 5 2008 01 30 17 01 2 Workshop user DE SE E r AALER e A a Menai E TEE CON EE ADOSNL LONE SEMAN ADOSO1 1 9NB 0068 01 30 ze om Stee USEF Description From row 7 Release for production 6 10 2 Electronic signatures on PCS 7 OS See e Notes in the GMP Engineering Manual WinCC V7 0 chapter 6 3 on the topic of Electronic signature e Product Support http support automation siemens com DE view de 24458155 How can you verify a logged on user at runtime when using SIMATIC Logon e Product Support http support automation siemens com DE view de 27780448 Get Signature SIMATIC PCS7 V7 1 GMP Engineering Manual 94 A5E02795571 01 6 10 3 6 11 6 11 1 Creating Application Software Electronic signatures on PCS 7 ES Configuration data in the engineering system is subject to change control and it must be possible to trace any changes made The requirements of 21 CFR Part 11 regarding audit trails and electronic signatures do not usually apply to engineering systems If
114. in the WinCC Explorer and download to the CAS computer are essentially the same as for an OS server Network security The central archive server requires access to the PCS 7 terminal bus to obtain data from the OS servers To this end the CAS features a shared folder with the name ArchivDir to which the completed database segments of the OS servers are temporarily transferred If access from another network segment Internet Intranet is required please refer to the information contained in the manual SIMATIC PCS 7 Security Concept Integration in Lifebeat Monitoring Running the Project Editor also generates standard process control messages for the CAS which can be viewed by all OS clients via the message display The CAS is integrated in Lifebeat Monitoring in the same way as SIMATIC PCS 7 components as described in chapter 6 8 5 Monitoring PCS 7 components An OPC connection to the CAS simply needs to be set up via which lifebeat monitor ing can be performed SIMATIC PCS7 V7 1 GMP Engineering Manual 102 A5E02795571 01 Creating Application Software Visualization of CAS data Audit Trail Archiving 6 12 5 Archived process values can be displayed on OS clients in the form of trends or tables In order to visualize messages the integrated StoragePlus Viewer software package is used to define views of CAS databases The data made available in this way is published using the Internet Information Server and
115. individual items of data or any inputs or changes made in relation to them have a bearing on quality they must only be entered via the operator control level OS and if required assigned an electronic signature at that same location Data Backup Backup copies of the configuration data must be made at regular intervals during the configuration phase This ensures that the configuration data which has been created can be accessed again if defective hardware or a defective hard disk has been used for example It is also advisable to make a backup of the system partition containing the operat ing system SIMATIC PCS 7 process control system software etc Note The backup of the user software and the backup of the system partition with and without SIMATIC PCS 7 should be stored on external media for example MOD CD DVD network backup See also e Chapter 8 1 3 Regular Data Backups for operational phase Backing up the system configuration Hard disk images should be used to back up the operating system and the PCS 7 installation These images allow you to restore the original state of PCs Which images are advisable e Creation of an image of the operating system installation with all drivers and all settings for the network user administration etc without SIMATIC PCS 7 e Creation of an image of the installed PCs with SIMATIC PCS 7 e Creation of an image of the installed PCs with SIMATIC PCS 7 including all project
116. information on operation change control 7 4 3 Write protection for CFC SFC charts and SFC types CFC SFC charts and SFC types can be provided with write protection to ensure safe operation of the plant after commissioning and verification If the write protec tion is enabled the operating and maintenance personnel can only open CFC SFC charts and SFC types and monitor process values online They cannot perform intentional or unintentional changes to charts and types To enable write protection write protection must be selected in the properties of the chart folder for each automation station see figure FJ SIMATIC Manager ENG HAN TEST File Edit Insert PLC Yiew Options Window Help Doe BP teg Sa Po e SS Eil NoFiter gt Jy geen ei G F ENG_MAN_TEST Plant iew E Projekte ENG_MAN_ KS ENG MAM TEST way Unit_002 ES AS02 ER Process_Cell_001 H Globale Deklarationen Ew Process_Cell_001 E E Unit_001 et EMOOT Gay Unit_002 Properties Chart folder Ea General Advanced Version Name Pl ne Project path Process_Cell_001 SASO1MCPU 416 3 DP S7 Programm 1 Technological path De Storage location of project E Projekte 4s01 Author FO Date created 08 28 2009 09 32 44 Last modified 09 09 2009 11 42 20 ed ENG MAN TEST E ES Process_Cell_001 OR Aso GR CPU 416 3 DP Gest 7 Programmf1 Comment TTT Bj Quellen EH Bausteine o i Pl ne E Gei ap Am jj Globale Deklaratione
117. ing of Library moduls User blocks SFC Types l SEN tee teat eveatat tect Shared Declarations Process Taq Types create test Models for Equipment moduk Unit create test 5 3 1 Synchronizing shared declarations Shared declarations are generated in the master data library automatically when the multiproject is created These declarations can be synchronized to make them available in all projects Centralized maintenance in the master data library is strongly recommended in order to ensure consistency throughout the multiproject Gs TUW _MP Plant iew OO TUWY KAS TUW _MP Objectname Type LJ Enumerations E numeration Units Units Equipment Properties Equipment Properties Cut Chr Copy Ctrl i ES Equipment Frog Paste Sty Ce Models GR Process tag types Delete Del Insert New Object Access Protection Shared Declarations Synchronize in Multiproaject Display Full Log EE EE EES SIMATIC BATCH Logs SIMATIC Route Control Rename F2 Object Properties Alt Return SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 49 Project Settings and Definitions 5 3 2 Synchronizing SFC types SFC types must be created and maintained in the master data library in order to achieve data consistency These types can be synchronized to make the current SFC types available in the projects Differences can be evaluated using the Version Cross Manager prior to synchroni zation EZ SIMATIC Manager TUWV7_MP Fi
118. installed without configuration should be treated analogous to category 3 or 1 The configuration part based on installed products libraries function blocks etc then corresponds to category 4 If free code is then programmed as well this corresponds to category 5 and involves significantly more effort for specification and testing SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 113 Support during Verification 7 3 2 Verification of software products During verification of the Standard software products in use checks are made to verify whether or not the installed software meets the requirements of the specifica tions These are usually products that are not specifically designed for a customer and which are freely available on the market for example e Operating system e SIMATIC PCS 7 software packages OS server OS client CAS engineering system BATCH server BATCH client etc SIMATIC IT server e SIMATIC add ons such as SIMATIC BATCH SIMATIC Route Control SIMATIC PDM SFC Visualization etc e Standard libraries e Acrobat Reader MS Office Word Excel etc Operating system and other software packages The installed software can be verified by operating system functions The informa tion can be found in the Control Panel gt Add Remove Programs All installed software components are displayed there Installed SIMATIC software Installed SIMATIC software can be verified using the Inst
119. ith the plant operator Note The projects to be archived must not be opened in the SIMATIC Manager SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 Support during Verification The procedure described below explains how projects are versioned 1 Create archive Link project or library to this archive Name project or library inside of the library Start archiving Versioning and comment Finished versioning incl version number and history Several multiprojects projects and libraries can be assigned to one archive repeat step 2 5 If a new project version is required steps 4 and 5 must be repeated SIMATIC PCS 7 Version Trail can be opened via the Windows Start menu or via the SIMATIC Manager Comparing archived projects The Version Trail interface enables archived projects to be compared with one another or with online versions Version Trail makes use of the Version Cross Manager here by calling it and displaying any deviations see chapter 7 4 2 Version comparison with Version Cross Manager VXM for more on this SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 121 Support during Verification Version History 7 4 2 122 SIMATIC PCS 7 Version Trail manages all actions relating to a versioned project such as creating archiving and deleting versions in the version history The version history can be called up using the Options gt Versi
120. ive and offices if you have any questions about the products described in this manual and do not find the right answers You will find your contact partner at http Awww siemens com automation partne A guide to the technical documentation of the various SIMATIC products and systems is available at http Awww siemens com simatic tech doku porta The online catalog and online ordering system are available at http mall automation siemens com SIMATIC PCS7 V7 1 GMP Engineering Manual 4 A5E02795571 01 Introduction If you have questions on the manual contact IA VMM Pharma at E mail oharma aud siemens com You can find additional information about the products systems and services from Siemens for the pharmaceutical industry at http Awww siemens com pharma Training center We offer various courses for newcomers to SIMATIC PCS 7 Contact your regional Training Center or the central Training Center in D 90327 Nuremberg Germany Internet htto www sitrain com Technical support You can contact the Technical Support for all the IA amp DT products using the Web form for the support request http www siemens de automation support request Additional information about our technical support is available in the Internet at http Awww siemens de automation service Online service amp support In addition to our pool of documentation we offer you a comprehensive online our knowledge base at http
121. kup data can be copied back again using the Restore command Recording and Archiving Data Electronically Several steps have to be performed in order to record and archive data electroni cally e Definition of the data to be archived the archive sizes and the suitable archiv ing strategy e Setup process value archives for the online saving of selected process values e Setup parameters for transferring the archives to the archive server time period or amount of storage space used Determining the data to be archived Various factors must be taken into account when defining the archiving strategy and determining the required storage space for example e Definition of the data to be archived process values messages batch data and batch reports audit trail data log files etc e Definition of the relevant recording cycles e Specification of the period of storage online and offline e Definition of the archiving cycle for transfer to external storage SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 6 12 2 Creating Application Software In PCS 7 this data is saved in various archives e Process value archive Tag Logging fast archiving of process values lt 1 min e Process value archive Tag Logging slow archiving of process values gt 1 min e Message archive Alarm Logging e OS and batch reports In other parts of the system actions are monitored and recorded in log files or databases e Change log
122. l safe input signal If a power failure occurs an additional alarm can be generated to inform the operator of the power failure alarm message By logging it in the message system this power failure can be used for subsequent investiga tions With power failure concepts safe states can also be implemented immediately or after a certain delay for example equipment phase hold establishing a safe plant status even after power has returned etc SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 107 Creating Application Software L1 protection UPS module SEN UPS module 220V ohase failure protection 24 Fail Sate Input OS Server Ethernet CP AS CPU 41x Power supply 24 Digital input module UPS buffering of power supply 6 13 3 108 In addition to phase monitoring the OS server is also buffered by standard UPS 220 V modules This ensures that the server continues to operate even after a power failure UPS buffering informs the operator of the power failure by means of alarm messages for example Safe states can be introduced by the operator or through automated concepts The safe shutdown of the OS server can be indicated by PCS 7 alarm messages and initiated if the power does not return within a specified time This functionality increases the system availability after power restoration MASTERGUARD UPS systems All MASTERGUARD UPS systems belong to the online UPS category
123. le Edit Insert PLC View Options Window Help gt ea Deg Settings for Copying Moving Ka TUWV7_MP Compone Shared Declarations Run Sequence E ES TUMWW Z MP Plant Hierarchy Generate Module Drivers e En TUWY7 Prj Process Glace Ze mie Data lt SIMATIC 400 1 Read back program ES34 _ Process Tags Logs H WinCC Appli Models L os 1 Update Block Types Shared Declarati SIMATIC Route Control TUWV7A i 2 TUWV7_Lib rem Gi Prog_Lib 3 TestMO Process tag types Process tag type Si Quellen G ert Process tag types Process tag type Bausteine VENVEN Models IEA CFC el Plane SFC TIME SFC type CH Shared Declarations z SFC Typ SFC type Process Objects Online 5 3 3 Synchronizing the plant hierarchy Three views are available in SIMATIC PCS 7 for configuration purposes e Component view for configuring hardware e Plant view for structuring the process engineering hierarchy e Process object view for centralized editing of parameters signals messages picture objects archive tags etc It is advisable to structure the plant hierarchy PH in the same way in all projects within a multiproject To do this place the PH in a project recommendation OS project and transfer this structure to all projects of the multiproject The shared declarations of the template project are also transferred to the selected projects as part of this process This forms a connection between the hierarchy folders
124. lease VO7 01 02 00 35 95 00 02 Version 7 1 2 4 Dr cken Sie F1 um die Hilfe aufzurufen SIMATIC PCS7 V7 1 GMP Engineering Manual 116 A5E02795571 01 7 3 3 Support during Verification Verification of the application software During verification of the application software checks are made to verify whether or not the created software meets the requirements of the specifications FS DS You need to consult with the user to agree upon and create the test descriptions for example for FAT SAT These descriptions must take into account the com plexity of the software and the design specifications The aspects listed below are usually tested therefore this list can be used as a reference for qualification e Check the name of the application software e Check the technological hierarchy plant unit equipment modules individual control element etc e Software module test typical test e Check the communication with other nodes third party controllers MES systems etc e Check all inputs and outputs e Check all control modules individual control level e Check all equipment phases and equipment operations technical functions e Check the relationships between operating modes MANUAL AUTOMATIC switchovers interlocks start running stopped aborting completed etc e Check the process tag names e Check the visualization structure P amp I representation e Check the operator control policies access con
125. lection criterion is the priority of the systems Systems with higher priority are e Automation system AS e Archiving server e Operator station OS server e Operator station OS clients e Network components In any case it is important to include the systems for data logging in the buffering procedurte The logging should also record the time of the power failure The use of UPS systems is linked to the installation and configuration of software The following must be taken into account e Configuration of alarms regarding power failure e Determination of the time frame for shutting down the PC e Specification of the time frame of the UPS buffering The process control system must be programmed so that it is brought to a safe state after a specified buffer time in the event of a power failure SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 Creating Application Software 6 13 1 Configuration of a UPS The following table contains an example of the configuration of an uninterruptible power supply for an operator station in a process control system The same basic procedure can be used with automation stations a E Power failure The process control system computers are buffered by lt 10 seconds the UPS An alarm using a digital input in the process control system documents the power failure Power failure The process control system computers are buffered by gt 20 minutes the UPS e g for 20 minutes An
126. lities e Update of the technical documentation e Reassuring availability of up to date data backups e Execute the change in accordance with manufacturer documentation as the plant has been released for it e Document the activities performed e Qualification Perform and document the necessary tests e Creating new data backups may contain new system image In considering possible influences the following may be relevant e Modules typicals instances blocks alarm system in terms of function and display e Interfaces e Effects during download e System performance e Documentation specifications e Qualification tests to be repeated or performed for the first time Note The SIMATIC Customer Support provides support for software updates and project migration at http support automation siemens com SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 131 System Updates and Migration 9 2 132 See also e Product Support http support automation siemens com DE view de 3998093 7 Migrating to PCS 7 Due to growing requirements and upcoming enhancements to existing systems many plants must be modernized or at least expanded in the next few years For this reason the issue of migration which refers to the transition to a new genera tion of products featuring updated technology is becoming more and more important for a number of plant operators particularly in terms of process control engineeri
127. mpendium Part C Configuration can be divided into the following Working in the SIMATIC Manager e Creating and configuring BATCH systems e Creating the plant hierarchy e Compiling OS data SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 Creating Application Software e Generating BATCH types SFC type e Propagating BATCH types e Compiling instances e Transferring data to OS e Loading process cell data Working in the BATCH Control Center BCC and Recipe Editor RP e Reading batch data e Creating master recipes e Creating the recipe structure e Releasing master recipes for production e Creating an order e Releasing a batch e Creating ROP libraries typicals e Exporting importing recipes parameter sets etc 6 6 3 Important settings in SIMATIC BATCH Various project settings can be defined in SIMATIC BATCH These settings are described in detail in the relevant system documentation Online structure changes for recipe structures SIMATIC BATCH allows you to change recipe structures in both hierarchical recipes and flat recipes This applies to control recipes that have the status released planned or started However such online structural changes are intended only to provide additional functionality for master recipes during testing They serve to simplify the optimization of recipes Online structural changes cannot be performed during production master recipe released for production setti
128. must be made members of the SIMATIC user groups which have the appropriate authorization Configuring SIMATIC Logon The basic settings for configuring SIMATIC Logon are made with the Configure SIMATIC Logon dialog The available settings are described in SIMATIC Logon configuration manual Note Events such as successful and failed logons and logoffs password changes etc are stored in the EventLog database of SIMATIC Logon This must be taken into account when backing up data Automatic logoff Auto Logoff To prevent the logged on user from accessing parts of the system for which he is not authorized the Auto Logoff function must be enabled in the SIMATIC Logon configuration for a defined period of time Note The Auto Logoff function must be disabled on the operating system level otherwise the user interface will close down completely A screen saver should also be disabled when SIMATIC Logon is used Default user after user logs off 4 3 5 In the General tab you can define whether a default user should be logged on after a user logs off Unlike all other users the Default User user does not have to be created as a Windows user The Default User is a member of the DefaultGroup and Emer gency_Operator roles The permissions assigned to these groups are specified in the respective PCS 7 OS server client applications How access protection works SIMATIC Logon Service must be installed in order t
129. n E aso The project staff also has the option of enabling or disabling write protection for individual charts or SFC types The check box for Write protection for charts can be shown here in two different ways SIMATIC PCS7 V7 1 GMP Engineering Manual 124 A5E02795571 01 Support during Verification Background white and check mark black With this representation write protection is selected for all charts i Write protection for charts Background hatched and check marks gray With this representation at least one chart or SFC type is read only If the chart of a CFC SFC or SFC type is open you will see the following notice with write protected charts Open Chart 754 61148 x b s The Walei chart iz write protected A L and cannot be changed If the write protection is not enabled for all charts disabling and enabling write protection for the Charts folder once enables write protection for all CFC SFC charts and SFC types of each automation station Note In the process object view changes can then be made even when the chart folders are read only SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 125 Operation Maintenance and Servicing 8 8 1 8 1 1 Operation Maintenance and Servicing Operation and Monitoring Process visualization SIMATIC PCS 7 provides extensive process visualization Individually configured user interfaces can be created for each application for reliable p
130. nd SIP procedures with various flushing paths The use of SIMATIC Route Control becomes economical with as few as 5 parallel material transports The main benefit of this is in engineering The engineering is similar to the configuration of SIMATIC BATCH With the SIMATIC Route Control Center routes and partial routes are easily assembled The easy to understand visualization in SIMATIC Route Control Center makes it easy to allocate production and cleaning paths whereby the amount of validation and qualification is signifi cantly reduced Furthermore the material tracking is ensured by SIMATIC Route Control Route Control Log A Route Control server is needed in order to use SIMATIC Route Control Route Control servers can have a redundant configuration SIMATIC Route Control is configured on the SIMATIC PCS 7 engineering station Alarm Management An alarm system must be able to perform the following basic functions e Warn the operator in the event of problems in the plant e Provide information about the characteristics of the problem e Guide the operator to the most significant problem e Support the operator in evaluating multiple pending problems Specification The specification of an alarm system includes the following e Definition of formats for alarm line and alarm page e Message classes colors and priorities e Acknowledgment concept e g single acknowledgment e Event texts e g too high for a high alarm e Process d
131. nformation such as the version history Versioning the configuration in SIMATIC NET The version identification can be entered in the properties on the bus level system bus PROFIBUS 5 8 2 Versioning OS elements in PCS 7 During software creation all graphics reports C scripts and VB scripts created by the user must be assigned data such as an author date comment and version ID User objects picture typicals for example feature a version field for this purpose Scripts and user FBs SCL can be identified by means of their date of change the version identification and comment must be inserted in the script header in text format Configuration settings must be appropriately documented on the one hand to act as a reference for use in validation qualification and on the other hand to ensure they are available if the system needs to be restored SIMATIC PCS7 V7 1 GMP Engineering Manual 64 A5E02795571 01 Project Settings and Definitions Example for graphics fi Graphics Tesiqner UmtOi Pdl fy fe Edit Ven Tee grange Tools Window Help Det fe ae Ba i qee ev7 asalal eletra x M Malte addition IR held 2007 10 02 a Bu EEN Bir Femme e Ee CR CD SiN Sachs wits R NA BE i rte se te es Sele eS ee SE L E WI P bh vele e z n pk Sisi d a eg kk e hiss S Eat e 0Y EE EE ee Mars Miau e Je E Kall Author Comment Date dl P Meyer new construction 2007 08 21 Upper graphi
132. ng Siemens offers optimized migration solutions for the transition to SIMATIC PCS 7 This means that both users of previous Siemens control systems and of third party control systems can utilize the benefits of Totally Integrated Automation in their processes A customized migration strategy is designed taking into account the necessary qualification measures and based on the relevant general conditions such as the basis which is already installed and on which the migration is to take place defined plant stoppages usually as brief as possible etc SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 Index List A Access Drotechon 16 35 42 104 Alarm management 82 ele e e seats et te wpebieaeduesnes 11 elei 13 Aen lee EE 19 28 96 Asset manadement 85 110 118 126 ffe t TEE 17 18 86 87 PAE CHUN ING EE 103 PFOS EE 89 SIMATIC BATCH EE 90 Slorage PIUSs 22 oie a 104 Automation License Manager sessnenneeeen 115 B BACKUD EE 19 95 96 127 Gei OMA Re ee ao 99 Batch documentation 18 81 Batch Report oerein eseina 81 105 BIOCK ICON EE 69 C KEE 28 100 Category eler ico ice ea i ea 14 el TEEN 14 73 112 CFC oee a 24 60 124 Change Control 86 128 Change procedure ccccseececceeeeeceeeeeeseees 13 Condition monitoring seeessseseeesnneeenneeenenen 127 Configuration management 15 59 Continuous Function Chart 24 60 124 E Electronic recordS EEN 17 96 El
133. ng Started WYr 1 5F1 EOF 01 017 00_07 20 00 02 7 1 1 0 SIMATIC Route Control Server WPT 5P1 k0r 01 01 00_01 20 00 02 K7 1 1 0 SIMATIC Route Control WinCE Options WT SPI K07 01 01 00_01 20 00 02 K7 1 1 0 SIMATIC SFC V TIAHEI EOF 01 00 01_01 05 00 02 7 1 01 SIMATIC SFC Visualization S FY Wo HFT EOF 01 00 01_01 04 00 07 7 1 0 1 SIMATIC WinCC Configuration VFO 5P1 HF4 K007 00 01 04 _01 04 00 05 K7 0 1 4 SIMATIC WinCE Runtime VFO 5P1 HF4 k07 00 01 04_01 04 00 05 E 7 0 1 4 SIMATIC WinCE Smart Tools VFO 5P1 HF4 ED 00 01 04 01 04 00 05 7 0 1 4 SIMATIC WinCC A emote Publisher VFOSPT HF4 KD DUU D 01 04 00 05 7 0 1 4 STEF VDdiGbPhAHEA FS464 47 01 E454 TH W7 1 HEA EOF 01 00 01_01 05 00 07 7 1 01 Version Cross Manager Wiel HF E 07 07 00 07_07 05 00 01 K7 1 0 1 eee eee eee eee Ree eee deeg PPP esscessenaseeeecnaeeeeeenseceeeeeaeeeasseuscnnseeseeasseesseasseessensseues W3 7 5P2 BOS 07 02 00_07 15 00 07 W03 07 02 00 Erint Export SIMATIC software licenses The Automation License Manager SIMATIC tool provides information on the licenses currently installed on the process control PC To view this information open the Automation License Manager and select the PC partition on which the licenses are installed on the left side in the Explorer bar All available system licenses are now shown on the right in the window SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 115 Support during Verification UGE Automation
134. ng alarms e Manual hiding and displaying of alarms e Alarms hidden and shown automatically depending on process states Hiding alarms manually e The alarms are unhidden once a defined period of time has elapsed e Manually hidden alarms are acknowledged automatically e Manual alarm hiding applies to all clients of the relevant OS server e An operator message is triggered if alarms are hidden and shown manually Hiding alarms automatically Automatic alarm hiding must be configured and is always controlled via status blocks in the AS which hide or show state dependent alarms in conjunction with a SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 Creating Application Software hiding matrix Technological messaging blocks are assigned to a status block via the new block group block property EET BEGIE gj mm SE dE E Ee E ox N BOX Ge AN EE d eieiei Zeie OS Ka e CC e alarms ook S bk R e aech F s Eeer eer OR eres G SC di e Ce 7 d BE de xX d oe i bse de Ge de Gen de SE Kee Ge SS GC Se block group Note The main difference between message suppression and alarm hiding is that suppressed blocked messages are not even generated at the respective process tag does not and they are therefore not sent to the OS Neither are they recorded or archived Alarm hiding on the other hand only affects the visualization 6 8 5
135. ng system level This option must be disabled for operator stations in particular Computer properties General Startup Parameters Graphics Funtime Funtime m Language Setting at Runtime r Disable keps Englisch USA VG ChrisAlteDel M Al TAB m Default Language at Runtine gt i Chri Esc SSES 11 acs SEU Elle SE DL tege ara Ir tomaton m PLE clock setting Ce The PLC is is set to coordinated world time UTC preferred setting PLC is set to the local winter time all year WinCE V compatibility mode m Time basis for time display in runtime Local time zone r Central time and date formatting f Configure individual components SO8601 Swap format to all components Abbrechen Hilfe Some graphics cards also offer such settings which should be disabled Devices Color Schemes Hot Keys Rotation OpenGL Information Enable Hot Keys Enable Monitor lt CTAL gt lt ALT gt F1 Invoke Graphics Properties lt CTAL gt lt ALT gt Fl2 Rotate Normal lt CTRL gt lt ALToUp Rotate 180 Degree lt CTRL gt lt ALT gt Down 4 5 2 Configuration setting on SIMATIC PCS 7 OS Access to the operating system during process operation runtime is configured via the OS parameter properties Note It must also be ensured in PCS 7 OS user administration that th
136. ng the CPU load DOCPRO 7 3 4 Asset management can be used to analyze and document CPU utilization CPU Function Block x a STPrg_ AWMI QVAS_TUWT_1 LL dai ident v 0830 0831 0832 f 0833 0834 0835 oB36 SE 0838 m nets X start event lost m grosse gt alarm limit DOCPRO is a tool for creating and managing plant documentation DOCPRO enables the structuring of project data the editing in form of circuit manuals and the printout in a uniform print layout You can find information on this in the system documentation and in GMP Engineering Manual Step 7 chapter 4 4 3 Simulation for test mode SIMATIC PCS 7 enables the input and output variables of various blocks to be simulated The simulation is important for test purposes for example in the context of the FAT because it allows the project engineer to influence digital and analog inputs and outputs in such a way that complex functions e g temperature control can be represented and checked Enabling simulation 118 Simulation for test purposes can be enabled at the channel input or channel output driver blocks Using the example of a valve simulation is enabled at the SIM_ON inputs and the input can be simulated at the SIM_ input SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 Support during Verification DI_OPEN CH DI MODE IL oan 0 DO_CMD UE ol CR bp es 1 VALUE_OC QUALITY 0 SR OR 16 04MODE IC oan
137. ng with StoragePlus StoragePlus see also chapter 6 12 5 Long term archiving with is used for the long term archiving of process values messages batch data and reports from up to four servers The archives managed using StoragePlus can be cataloged and transferred to external media Process values can be read at a maximum rate of 1 000 per second per server If data is read from more than one server at once the maximum rate is 1 600 per second Long term archiving with the Central Archive Server CAS The central archive server CAS is used for the long term archiving of process values messages batch data and reports from up to 11 servers see also chapter 6 12 3 Archiving batch data The archives managed using the CAS process values messages batch data can be cataloged and transferred to external media Process values can be read at a maximum rate of 1 000 per second per server If data is read from more than one server at once the maximum rate is 10 000 per second The CAS server can also have a redundant design if required Application Software Specifications In addition to defining the standard software components used another essential task of the Software Design Specification SDS is to specify the application software This is then used as a basis for subsequent testing of the application software FAT SAT IQ OQ The SDS can be integrated in other specification documents FS DS However part of this spe
138. ngineering Manual 54 A5E02795571 01 Project Settings and Definitions Export functions in SIMATIC PDM In SIMATIC PDM the following field device data can be backed up via an export procedure e Device parameters e Change log changes sorted according to object e Calibration report contains information relating to commissioning and mainte nance as well as test results Note Version information can be saved in the device s comment field This information is then exported together with the device data In addition a version can be identified by the name given to the export file As the export file contains a reference to an appropriate transformation file the content of the export file is displayed in the Web browser in a readable HTML format The corresponding transformation file PDMExportEddl XSL for the device parameters and change log or PDMExportCalibration XSL for the calibration report is copied to the export file location as part of the export procedure Note If the export file is copied to a different directory or computer and the HTML display is to be used the corresponding transformation file must also be copied 9 4 5 FOUNDATION Fieldbus FF As well as facilitating communication via PROFIBUS or HART SIMATIC PCS 7 also offers interfaces for FOUNDATION Fieldbus H1 allowing a wide range of FF instruments and positioners to be integrated into the process control system The FOUNDATION Fieldbus H1 is conne
139. ngs for performing online structure changes e The master recipe has the status Release for testing e The user must have the structural changes permission e The check mark must be set for All online structure modifications in the project settings as shown below SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 19 Creating Application Software Project settings for BATCH_TEST_EM Used Plug in Modules Report Electronic signatures General Warnings Color Font Archive versioning Max number of substructure levels E M Automatically resolve excess substructures M Allow simultaneous ROPs M Allow editing of recipes with Release revoked status M Allow online setpoint change Transfer online setpoint change to active step T Unit selection according to conditions Allow importing of materials T Display indexes chronologically i rchived batches h Active batches must be stopped Default Cancel Help If the option Active batches must be stopped is selected this provides protection by bringing the current batch to a safe state when changes are made to recipe structures Changes are then only possible if the active batch has been stopped Once the change is made the batch must be resumed by the operator thereby guaranteeing a controlled procedure If the option Active batches must be stopped is disabled the change can be made during ongoing operation whic
140. nsnnnnnsnnnsnnnesenrnnsnnrnsnrresrnrenne 6 10 2 Electronic signatures on PCS 7 OD 6 10 3 Electronic signatures on PCS 7 ES a 6 11 Dala et E EE 6 11 1 Backing up the system configuration ccc cceeecceeeceeeeeeceeeeeeeeeeeeeeeeeeeesaeeeesaaeeeeesaaes 6 11 2 Backing up the user scofbware cc cceccccceeeceeceeeeeeseeeeeesaeeeesaeeeeesseeeeeeseaueeesaneessaaaees 6 12 Recording and Archiving Data Electronically ccccccceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeesaaees 6 12 1 Determining the data to be archive ube 6 12 2 Setting up Process value archives ccc cece seececseeeeceeeeecececeeeesseeeessaeeeseeeeseneeesaaees 97 AZS GIVING Re e BEE E A E 99 6 12 4 Long term archiving with the Central Archive Server CAS 6 12 5 Long term archiving with StoragePlus n nnannnnnnnnenennnnnnnnnnnnnnsnnnenrnrnnsnrnennnnnennnnnn 6 13 Uninterruptible Power Supply UP 106 621351 COMNGUPATION ofa UPS EE 6 13 2 UPS configuration via digital INPUTS 00 cscs ee seeessseeeeeeeeeeesassssseeeeaeeeesasessneees 107 6 13 3 MASTERGUARD UPS systems ee ccceecceeceeeeeeeeeeeeeeeseeeeeeeeeeeesaeeeeesaeeeeeesaaeeeeeas H Support during Verification kee KERRKENRRR KEREN EEN RRR ENER EE RRE ERR EEERR EEN RRR EEN RRE ENEE EEN EEN 7 1 Ke cel e 6 e E E SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 H Table of Contents 7 2 Verification Of Hardware 7 3 Verification OF el 7 3 1 Software categorization according to GAMP Guid
141. nt Log Viewer Color Pr D Projekte ColorWColor_Pr SIMAT ie Manager brcecs contra Project opened a nd acces gra antad SIMATIC Manager Access ponbrol Project closed CF Target system Target system loaded Color Prasan CFCiSFC Target system Testi online mode deactivated Color Pr AS400 CFC SFC Target system Value of block parameter changed old value 0 new value 1 Coler_PrjlAs400 Parameber NEI24LOCK NE CFCISFC Target system Valse of Block parameter changed old value 0 new value 1 Color _Prj AS400 Paremeber NEI2SVALVELY CFCISFC Target system Test online mode activated Coker Pr SIMATIC Manager Access control Project opened and access granbed Coke Pr SIMATIC Manager Access control Project opened and access granted Coke Pn SIMATIC Manager Changelogging Change log enabled Color Pr d Comments bo the selected event Change control for AS download 88 In addition to the ES configuration being protected against unauthorized access via the Activate Access Protection project setting a CPU password can also be used to protect against unauthorized downloads being made to the CPU However as with online value changes downloads made to the CPU are not recorded unless the change log file is activated see chapter 6 9 1 PCS 7 ES above regarding ES change control SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 Creating Application Software Note The time at which this access protection should be a
142. nternet at ww siemens com automation ca0 1 A list relating to the compatibility of the various product versions is available at http support automation siemens com DE view en 2334224 Any questions about the compatibility of the add on products for SIMATIC PCS 7 should be addressed directly to the suppliers see Position in the information landscape The system documentation of the SIMATIC PCS 7 V7 1 process control system is an integral part of the SIMATIC PCS 7 system software It is available to every user as online help HTML help or as electronic documentation in PDF format This manual supplements the existing SIMATIC PCS 7 manuals The guidelines are not only useful during configuration they also provide an overview of the requirements for configuration and what is expected of computer systems in a GMP environment Structure of the manual The regulations and guidelines recommendations and mandatory specifications are explained These provide the basis for configuration of computer systems All the necessary functions and requirements for hardware and software compo nents are also described this should make the selection of components easier Based on examples the use of the hardware and software is explained briefly and how they are configured or programmed to meet the requirements More detailed explanations can be found in the standard documentation Additional support Contact your local Siemens representat
143. o tected against unauthorized access Depending on a user s particular field of activity a user can be assigned various rights Access to user administration should only be given to the system owner or to a very limited number of employ ees Unauthorized access to electronically recorded data must also be prevented The use of an automatic logout function is advisable and provides additional access protection This does not however absolve the user from the general responsibility of logging off when leaving the system The automatic logout time should be agreed with the user and defined in the specification Note Only authorized persons must be able to access PCs and the system This can be ensured by using appropriate measures such as mechanical locks and hardware and software for remote access Requirements of user IDs and passwords User ID The user ID for a system must be of a minimum length defined by the customer and be unique within the system Password When defining passwords the minimum number of characters and the expiry period for the password should be defined A password should generally comprise a combination of characters with a minimum length and should also meet at least three of the criteria listed below e Use of uppercase letters e Use of lowercase letters e Use of numerals 0 9 Use of special characters The configuration is described in chapter 4 3 Setting up User SIMATIC PCS7 V7 1 GMP Engin
144. o enable access protection SIMATIC Logon maintains users and user groups by means of the operating system s user administration The rights of the various users user groups to operator actions and the way in which they are logged on to the system are assigned on the operator control level in SIMATIC OS and SIMATIC BATCH and on the engineering level in SIMATIC ES according to the system specification SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 35 System Installation and Configuration 4 4 4 4 1 36 SIMATIC Logon Configuration WINDOWS Operating System User Administration Keep to this sequence of actions e Setup user groups and users under Windows e Configure SIMATIC Logon e Create a project e Configure user rights for the individual SIMATIC components ES OS BATCH Note Access protection needs to be configured in full prior to beginning configuration In addition individual user rights must be contained in the typical description All permission levels of the visualization interface faceplates entry fields buttons etc must be set up in accordance with specifications URS FS DS and tested during the course of the project Administration of User Rights Rights management on the ES Access to projects and libraries can be controlled using SIMATIC Logon When access protection is activated for new or unprotected projects the Windows user who is logged on is automatically defined as th
145. on ES level for Downloading the target system and online parameter changes e SIMATIC Logon database EventLog mdb e Event Viewer under Windows Computer Management logon logoff activities account management permission settings for the file system etc according to the corresponding configuration Note All the files mentioned and others if required must be considered in the archiving concept Setting up process value archives The procedure for configuring a process value archive is broken down into the following steps e Creating the new process value archive and selecting the tags to be stored in the short term archive e Configuring the process value archive by specifying or selecting access permission levels or the storage location for example The process value archive is used to record tag related process values analog and binary values in a database in the form of a short term archive The size of the short term archive is defined in the specifications URS FS DS Note The segments in the short term archive must be created in such a way that they are transferred at regular intervals ensuring that no data can be lost SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 97 Creating Application Software 98 Archive server long term archive Process value and Batch data message archive E and reports short term archive BATCH server redundant OS server redundant In
146. on History menu All actions relating to the archiving of projects and deletion of versions are logged The figure below shows an example version history from the creation of versioned project Sample1 through to the archiving of different versions Version History New versioned project Version 01 30 2008 12 37 54 PM Manuel Versioned project created as Di archivel version New archive Woor Pri 01 30 2008 12 38 12 PM Manuel Project Volo Pri pasted archive version color Dr 01 30 2008 12 39 05 PM Manuel Color Pri Version 1 0 of D VroiektevColorvColor Pr archived New archive olor Pri 2 01 30 2008 12 48 16 PM Manuel Project Color Pri CG pasted Archive version Waler Pri 2 01 30 2008 12 49 43 PM Manuel olor Pri ST Version 1 0 of D VroiektevColorvColor Dr archived Print Print Preview Help ae When using SIMATIC PCS 7 Version Trail for continuous archiving the version history is a good way of documenting different software versions during an automa tion system s life cycle All software versions are listed in chronological order together with their archiving date and version This ensures that the latest software version can be copied back should the application software be lost Version comparison with Version Cross Manager VXM The Version Cross Manager compares the following objects within projects e Hardware configuration e CFC SFC engineering data such as chart
147. or can use this feature to suppress messages which are of no immedi ate use allowing him to focus his full attention on the relevant messages On all levels operators are able to identify objects whose message reaction has been suppressed Filtering messages Message filtering within alarm lists can be adapted on a user specific basis The filter criteria are message properties date time message class message text etc The point of changing filter criteria online is to enable the user to temporarily focus on a particular period event etc when analyzing errors Hiding messages Smart Alarm Hiding 84 This function allows alarms to be hidden on a situation specific basis These messages are not taken into account when generating the collective status i e the collective status of a measurement with a pending hidden alarm does not indicate an alarm status in the process picture is ignored when the collective status display is generated for the diagram and does not output an audible signal alarm horn The currently pending hidden messages can be viewed at any time in the list of hidden messages All messages hidden by the current setting are summarized in the Messages to be hidden list The messages are only hidden in terms of the display Le hidden messages are still archived and taken into account during archive synchronization if a server redundancy failover is performed Smart Alarm Hiding offers two ways of hidi
148. perations to perform the process engineering task can be clearly structured e Separation of Procedures and Formulas Separating the procedure and the parameter sets further increases flexibility by means of recipes which are not specific to a particular unit e SIMATIC BATCH API The SIMATIC BATCH application programming interface API is an open in terface which enables the user to access SIMATIC BATCH data and functions via the plant control level for example e Batch Planning Batch planning and control are supported in a user friendly manner and simpli fied thanks to special displays such as the order category list production order list batch planning list batch status list or batch results list Refer to the system documentation for more information on using and configuring the add on packages SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 2 System Specification 3 4 3 4 1 3 4 2 3 4 3 3 9 28 SIMATIC Additional Software SIMATIC PCS 7 add ons The SIMATIC PCS 7 Add On catalog contains solutions for various areas of application or special branches such as the process industries The addresses of the relevant contacts for these add ons are listed in the catalog Recommendation When implementing functions that go beyond the standard scope of PCS 7 oriority should be given to add ons from the current catalogues https ocs khe siemens com index pcs 7 add ons 6811 htm Long term archivi
149. ple in US FDA 21 CFR Part 11 Electronic signatures are of practical relevance for example when entering data and intervening manually during runtime approving process actions and data reports and changing recipes Each electronic signature must be uniquely assigned to one person and must not be used by any other person Note The FDA regulations including 21 CFR Part 11 relating to electronic signatures must be satisfied in the manufacture of all pharmaceutical products and medical devices that are intended for the US market Conventional electronic signatures If electronic signatures are used that are not based on biometrics they must be created so that persons executing signatures must identify themselves using at least two identifying components This also applies in all cases where a smart card replaces one of the two identification components These identification components can for example be a user ID and a password SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 17 Requirements of Computer Systems in a GMP Environment The identification components must be assigned uniquely and must only be used by the actual owner of the signature Electronic signatures based on biometrics 2 8 2 9 18 An electronic signature based on biometrics must be created in such a way that it can only be used by one person If the person making the signature does so using biometric methods one identification component i
150. pter EE EE these segments must be reconnected to the required time period To achieve this the segments are copied back to the CAS from the external storage medium The example shown in the figure below illustrates possible access options for displaying trends and tables Tag Logging on the OS clients SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 Creating Application Software Long term archive Automatic transfer of data older than the specified period CAS Server 1 Short term archive Process archive values Server 2 Se Short term archive Client 2 veel s KA Messages Server 3 i Sch Short term archive Client 3 Batch reports LA Installation The database storage location usually partition D on the hard disk must be defined when the CAS component is installed Integration in the SIMATIC Manager The CAS is centrally configured on the engineering station as described below A PC station must be created in HW Config and the WinCC CAS Appl HMI application added to it If the CAS is to have a redundant structure a second PC station must be configured with WinCC CAS Appl stby The archiving settings are made in the CAS Properties dialog These settings can either be made collectively for all archive types or separately for each individual type Segment data remains available even after it has been copied to the specified backup location The segment is only delet
151. quest See also e Product Support http support automation siemens com DE view de 2396 7880 How are block parameters labeled specially for read back SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 87 Creating Application Software Change control of the ES configuration and ES project engineering The Version Cross Manager is suitable for controlling the offline configuration in the ES when used in conjunction with a defined change process and an appropri ate strategy for backing up project data This enables different project versions to be compared against one another see chapter 7 4 2 E Merion comparisen wih ersion Cross Manager VXM The current status of the offline online configuration can also be verified by activating test mode in the ES Parameter read back also has to be taken into account here see Note above Project access activities and online changes performed on the ES are recorded with the aid of the SIMATIC Logon change log in a similar way to an audit trail who has changed what and when The following are logged e Events relating to access protection open project access to project denied activate deactivate access protection etc e Target system events AS configuration loaded software application loaded online mode activated deactivated e Events relating to online value changes old value new value e Version changes archiving of versioned projects EE SIMATIC Logon Eve
152. r interventions are made in the system evidence must be provided at all times as to who has performed the change what the change involved and the time the change took place the why is optional The requirements of this task are implemented in various functions and described in the following chapters Note This chapter provides the general requirements for computer systems How to meet these requirements with a specific system is dealt with starting at chapter 3 Categorization of Hardware and Software Hardware categorization According to the GAMP Guide hardware components of a system fall into two categories standard hardware components category 1 and custom built hardware components category 2 Software categorization 2 2 14 According to the GAMP Guide the software components of a system are divided into various software categories These include commercially available and preconfigured standard software products that are simply installed configured software products right through to custom applications programmed software Test Effort Depending on the Categorization The effort involved in validation specification and testing is much greater when using configured and in particular customized products compared to the effort for standard products hardware and or software The overall effort for validation can therefore be significantly reduced by extensive use of standard products SIMATIC PCS7 V7
153. reducing the amount of configuration work required but also and more importantly of creating a clear software structure This helps to simplify the associated documentation and a risk based definition of the testing work involved while also supporting subsequent system maintenance Modules and typicals in PCS 7 A distinction is made in SIMATIC PCS 7 between an SFC type a process tag type and a model Interface to SIMATIC BATCH for operating equipment phases equipment operations for example e Heating e Agitate e Drain Process tag type A CFC chart for example e Valves e Pumps e Motors Combination of several CFC and or SFC charts for example e PID tempering of a tank e Level monitoring including safety shutdown to protect against overflow of tank The mode of operation of the modules must be described in a specification in which the parameter assignments MES relevant archiving block comment unit of measure etc and interconnections are defined More detailed information can be found in chapter 2 4 oftware Creation SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 67 Creating Application Software SFC type Notes Modules are named in accordance with the Functional Specification and the Design Specification The modules typicals must be verified and approved by means of a module test before they are duplicated An up to date record of the software modules used must be kept for eac
154. rocess control and optimization of the entire production sequence Runtime data can be output by the system based on reports Asset management In the context of process engineering asset management aims to use appropriate methods to ensure that a production plant benefits from maximum availability at the lowest possible operating costs The most efficient strategy is without doubt status oriented maintenance which must be based on a status detection procedure that is as continuous as possible Asset management relies on having access to precise information relating to the current plant status which can then be used to deter mine exactly which maintenance activities need to be carried where and at what time Implementation in PCS 7 126 The asset management integrated in SIMATIC PCS 7 is used for plant mainte nance Additional hardware and software tools are not required Plant operators and maintenance engineers use the same SIMATIC PCS 7 tools and user inter faces along with information which has been filtered and prepared according to the field of activity concerned While the plant operators operate and monitor the process on the PCS 7 operator station OS the maintenance engineer uses the maintenance station MS to control the hardware structure of the production facility in order to handle the diagnostics and maintenance requirements The various components of a PCS 7 plant can be monitored with the diagnostic and maintenanc
155. s SFC Visualization add on software An SFC sequential function chart is used for the sequential control also known as a sequencer of processes SFCs consist of a sequence of steps that are separated from one another in each case by step enabling conditions or transi tions Using SFC Visualization the configured SFCs can be displayed on the operator station and operated in manual mode Processes can be clearly displayed by showing their different process actions No additional effort is necessary to configure the SFC visualization Open PCS 7 add on software 26 Open PCS 7 can be used to exchange data with external systems such as the plant management and production control level MES level or ERP level via the OPC interface without knowledge of the PCS 7 project topology being required OPC OLE for Process Control refers to a uniform vendor independent software interface the standard of which was defined by the OPC Foundation The OPC Foundation is an alliance of leading companies in the field of industrial automation Information on OPC can be found on the Internet at htip www opcfoundation org the use of Open PCS 7 is described in more detail in chapter Open PCS 7 SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 System Specification OS Web Client add on software 3 3 5 The PCS7 OS Web option enables the PCS 7 plant to be operator controlled and monitored via the Intranet or Internet
156. s Note An image can only be imported on a PC with identical hardware For this reason the hardware configuration of the PC must be suitably documented Images of individual partitions cannot be exchanged between PCs because various settings differ from PC to PC for example those in the registry SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 95 Creating Application Software 6 11 2 Backing up the user software Backing up user software in the engineering system It is advisable to back up project data at regular intervals during the configuration phase and when changes are made to released user software The SIMATIC Manager Archive Project system function should be used for this purpose or if version specific eck required the Version Trail add on package should 4 1 be used see chapter Versioning Projects with Version Trail Note If data backups are to be created during plant operation consideration must be given to whether and if so which online parameters must be read back prior to generating the backup Parameter changes which are not read back will be lost if the system or project is restored Backing up recipe data in SIMATIC BATCH 6 12 6 12 1 96 The project configuration must be backed up in PCS 7 as must application data in SIMATIC BATCH libraries master recipes materials user rights etc This backup is created from within the SIMATC BATCH Control Center The bac
157. s e Display change log Project administrator e Make project changes e Display change log e Enable and disable the change log e Manage access protection e Disable access protection e Synchronize access protection in the multiproject SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 3 System Installation and Configuration Note In order for a user to be assigned to permission roles he must already be known in Windows user management The following presents three possible scenarios for establishing and using pro tected projects libraries Scenario 1 e SIMATIC Logon installed e User known in Windows e Access permission for the project available When the user has the required permission he can open a project without any further authentication provided it is in the same network as the user This also applies if the project has been taken out of the multiproject Scenario 2 e SIMATIC Logon installed e User known in Windows e Access permission for the project not available lf a user does not have access permission protected projects libraries are dis played in gray Seles E SIMATIC Manager TUWV _MP File Edit Insert PLO View Options Window Help D EH aa me MN E TUWV7_MP Component view D GG TUWV7_MP TUWV_MP 7 MP So a io 25 Sal SE Se CJ ES Project access protected lt Project access protected g TU Lib E lt Project access probected gt joni Proj
158. s types chart folders block folders e Shared declarations e Block sequences e S program e S7 blocks e S symbols SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 Support during Verification The projects to be compared are executed synchronously i e the object trees of the corresponding software structures are compared attribute by attribute Any differences detected by the comparison are highlighted in color in a results tree Le z oF SIMATIC Version Cross Manager TUWV7_Prj D ATUWV7 ES TEMP_ENW Pro_1_ S7Pr_Prj FA File Edit View Options window Help A ioe 7 Value of project A EE Sisi ai lalele az eieiei A TUW Prj D VIUWVZESUTENMD ENG zpro 1 Vezpr Dr B TL Prj Ds TUWN ES TMP2 EMLWGEZ Vu Pr _ Value of project B Eh Bods A UR attribute ai y B ooo y i Ki DP Measuring range H 104 i 10 NM Ji MPL DP Measuring range 104 a ee NM a CP 443 1 Measuring range i i l Eh CF 443 5 Ext ZERO MALUE TRA DEACTIVATED Measuring range ge type EN BR Ca Se IM 153 2 redundant i Eh IM 15 2 eo ED A DeD Interrupt E H DoseDc24y 0 54 A ag ATE 1 Bit Sg ER H ao4x128it ER H Dlt xbC24 Interrupt H g E posypce4yio 5a GLEN Tat Shared Der er Ins Curent color ef i Foreground Also in B wi A Object changed Background oe p Object and lower level objects changed H Lowerlevel objects changed E
159. s adequate Biometric characteristics include fingerprints iris structure etc Audit Trail The audit trail is a control mechanism of the system that allows the tracking of all data entered or modified A secure audit trail is particularly important when GMP relevant electronic records are created modified or deleted Such an audit trail must document all the changes or actions made along with the date and time The typical content of an audit trail describes who changed what and when old value new value as an option it may also include why Reporting Batch Data When producing pharmaceuticals and medical devices batch documentation takes on a special significance For a pharmaceutical manufacturer methodically created batch documentation is often the only documented evidence within the framework of product liability The components of batch documentation are as follows e Manufacturing formula processing instructions and manufacturing log e Packaging instructions and packaging log from a pharmaceutical point of view the packaging of the finished medicinal product is part of the manufacturing process e Test instructions and test log relating to quality checks for example analysis The manufacturing log or packaging log has a central significance here and this is defined below e The manufacturing log is always both product related and batch related e tis always based on the relevant parts of the valid manufac
160. s scanners are used the following settings must be observed e The real time search is one of the most important functions It is sufficient however to restrict the analysis to incoming data traffic e The time controlled search should be deactivated as it significantly limits system performance in process mode e The manual search should not be executed during process mode It can be run at regular intervals e g during maintenance cycles These specifications must be laid down in an SOP SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 29 System Specification 3 6 3 Image amp partition tools Add on software for a disk image and partition enables you to backup the entire contents of hard disks by making an image of the disk as well as to partition disks Backing up system and application software by means of such an image can be used to quickly restore a system Backed up hard drive contents can also be exported to devices with identical construction This simplifies the replacement of computers Siemens provides the software package SIMATIC Image and Partition Creator IPC to perform these tasks This can even be done without separate installation by starting the program directly from CD or USB Flash Drive Note The created images are used to restore the installed system but not to back up online data Administration skills are required for the selection and configuration of this software component
161. t also the complexity of the component to be tested A suitable test environment and time as well as appropriate test documentation can help to ensure that only very few tests need to be repeated or even none at all SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 109 Support during Verification 7 2 The individual tests are planned in detail at the same time as the system specifica tions FS DS are compiled The following are defined e Procedures for the individual tests e Test methods e g structural code review or functional black box test Verification of Hardware Tests are performed to verify whether the installed components and the overall system design meet the requirements of the Design Specification This covers such aspects as component designations firmware product version location server and clients used interfaces etc Note Printouts and screenshots can each be used as evidence A visual inspection of the hardware can also be performed Verification of field devices Field devices are specified and tested by means of the following information for example e Identification of manufacturer and type e Order number e Function installation location e Process tag name measuring range unit of measure e Type of connection e Address number Note SIMATIC PCS 7 Asset Management can offer support here Verification of the automation hardware 110 Automation stations are specified
162. t be guaranteed within a system to be able to assign an unequivocal time stamp for archiving messages alarms etc Time synchronization is especially important for archiving data and analysis of faults UTC Universal Time Coordinated defined in ISO 8601 is recommended as the time base for saving data The time can be displayed in local time with a note regarding daylight saving time and standard time Use of Third Party Components When third party components hardware and software are used their compatibility to other components in use must be confirmed If components specifically tailored customized to individual projects are used a supplier audit should be considered in order to check the supplier and their quality management system See also e GAMP5 Guide Appendix M2 Supplier Assessment SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 3 1 3 1 1 System Specification System Specification During the specification phase for a computer system the system to be built and its functionality are defined in as much detail as is required for setup This also includes the selection of products product versions options and system configura tions Planning Reporting Configuration and or Coding Supporting Processes including Risk Management Specification of the System Hardware Selecting the hardware components Use of hardware components from the PCS 7 catalog ensures the long term availability of
163. the active server fails the station switches to the remaining server automatically so that this server carries out the next read job An uninterrupted read job is repeated on the server which is then active The figure below shows a multiple station system with a client server architecture The Open PCS 7 client station is equipped with two network adapters OPC client PC requests in the office network are transparently forward out of the Open PCS 7 station to the OS server or the central archive server CAS which responds to the request OPC Client in Office Network Client1 Client 2 7 Station as OPC Server SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 19 Creating Application Software 6 5 3 6 6 6 6 1 76 Access to the OPC interface Data type Type of access station OS server Mimic diagram tags Read and write A amp E Alarms and messages Read and Alarm Logging acknowledge HDA Historical measured values Read Tag Logging DA H A amp E Historical alarms and Read messages Alarm Logging C H Historical measured values Read Tag Logging SIMATIC BATCH API OS server OS server OS server AS The SIMATIC BATCH application programming interface API is an open inter face which facilitates access to SIMATIC BATCH data and functions Recipe Control with SIMATIC Batch SIMATIC BATCH is a software package for PCS 7 which structures discontinuous processes known as batch processes
164. the basis of the ANSI ISA 88 01 1995 Batch Control Part 1 Models and Terminology standard One of the recommendations contained in the Technical Report SA 7TR88 0 03 1996 is the use of SFC Sequential Function Charts DIN IEC 1131 as a graphic language for describing recipe procedures Recipes created with the BATCH Recipe Editor follow the structures and functionalities described in this standard SIMATIC PCS 7 software model ISA 88 01 describes various models which can be fully implemented with PCS 7 and SIMATIC BATCH FF SIMATIC Manager Demo ECH j Die a Se ES lale el Sal jo zl Process Cell Las Cae Iesel Recipe m Procedure ssing paren i 2 i Transfer ees welating pam Control f Module e ansfer Weess The process cell model physical model describes the process cell unit equip ment module and control loop level which is mapped using the plant hierarchy in the plant view of the SIMATIC Manager In SIMATIC BATCH the procedural model procedure unit procedure operation phase reflects the plant model from the point of view of the control sequence Description Recipe A recipe procedure runs in a process cell to control a process and to create procedure a batch of a product Recipe unit A recipe unit procedure runs on a unit to control a recipe stage A unit can procedure only be occupied by one batch
165. tions for Blocks e Manual PCS 7 Compendium Part A chapter 5 1 2 Creating user defined technological blocks Interfaces to PCS 7 PCS 7 OS Web Option This option enables PCS 7 system processes to be controlled and monitored via an Internet Intranet connection One PCS 7 OS Web server and at least one PCS 7 Web client is required Within a PCS 7 OS multiple station system the PCS 7 OS Web server is installed as an OS client with PCS 7 OS Web server functionality It should not be used as an operator station OS client This can be ensured by deactivating graphics runtime The WebViewer is installed automatically when the Web client is installed For remote access it is advisable to use this in preference to the Internet Explorer since the WebViewer can be custom configured The Web server itself should be certified so that access to Web server functions is secure authenticated and encrypted keyword https access All pictures and required scripts are stored on the OS Web server so that they can be displayed and run on the Web client All pictures and scripts must be published The Web View Publisher is used for this See also e Manual PCS 7 OS Web Option the topic of using scripts e Manual PCS 7 V7 0 Programming Instructions for Blocks chapter 2 1 10 WebClient differences compared to WinCC e Manual PCS 7 Compendium Part A chapter 7 2 Visualization interface Note If scripts are used preference should
166. tored Backup restore for the SIMATIC BATCH database When a BATCH database is read a start batch ID can be assigned this prevents batch IDs being assigned more than once This dialog box also specified whether or not the associated log is to be imported Restore Suchen ir 9 Demo Doele Ki rk AN Ki 5B6_2 124105692946 sbb Zuletzt verwendete D E Desktop 1 WA Eigene Dateien Arbeitsplatz Dateiname SB6_2 124103692948_demo __2007_0 amp _27 Hetzwerkumgeb Dateityp Backup files 7 sbb sm Abbrechen Start batch ID 1734 Without og SIMATIC PCS7 V7 1 GMP Engineering Manual 130 A5E02795571 01 System Updates and Migration 9 System Updates and Migration 9 1 Updates and Service Packs It is essential that system software updates for a validated plant are agreed with the user An update such as this represents a system change which must be planned and executed in accordance with the applicable change procedure Similar to the description in chapter 8 2 hange Control during Operation this roughly means the following steps e Describe the planned change e Effect on functions plant units documentation inclusion of the system description of the new and modified functions in the readme file release notes e Assess risks e Define the tests which need to be performed to obtain validated status based on the risk assessment e Approve reject the change in accordance with defined responsibi
167. trol group permissions user permissions e Check the archiving concepts short term archives long term archives e Check the message concept e Check the trends curves e Check the time synchronization Note If other blocks are needed in addition to the PCS 7 standard libraries in order to configure specific processes or functions the block libraries FB FC DB of the PCS 7 add on catalog should be used if possible If blocks created by the user are to be employed significantly more work will be required in terms of specification creation and validation this fact should be taken into consideration The process object view can be used for testing revisions for valida tion qualification purposes The software versions can also be modified there see figure SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 117 Support during Verification gq Unit_002 ESENMG MAN TEST Process Object view E Projekte ENG_MAN_ ed ENG MAN TEST E3 of General Blocks Parameters Signals Messages Picture objects Archive tags Hierarchy folder Equipment properties Shared declarati Filter by column Display I lt No filter gt sl geal E ei Hierarchy Name Comment Type Processfag Version Jop Jop 1 Process_Cel_OOT Unit_OOTXEMOO1S Tan ValveD01 DFL re Jumm FR Globales Schriftfeld Process_CelL_OO1 Unit_OO2 EMOO1S f Valvel02 EC Lk 0 0001 fag Analge_001 Analyzi
168. ts which act as control functions in the controller e OS elements which are used for operator control and monitoring Versioning AS elements in PCS 7 The individual configuration levels in PCS 7 provide various options for assigning a version identification and possibly an author and comment to each element Versioning blocks CFC charts and SFC charts 60 For blocks CFC charts and SFC charts as well as for SFC types and models version numbers are managed in the properties of the respective object SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 Project Settings and Definitions 4 SIMATIC Manager BATCHY70 File Edit Insert PLC View Options Window Help De BP ae amp Bae we fo Bel Be EIST E lt Neie Jy 2 S 5 ES BATCH 70 Component view D BATCH Batchy70 BATCHY70 Name Header St EM_TEMPLATES a System data 5 SDB Ss SIMsTIE 490 T 0835 SCL 58 Organization Block P Re 8100 SCL 58 Organization Block 0 0 s mg lore STL 38 Function Block 01 V21BR1 a gess Jeree TIMER_P SCL 702 Function Block 13 TIMER_P fi d ei yan g FB245 fraser ARZI srl 1493 Function Block 7 0 SFC_BZL ayer ea re 70 cro ESM L I Shared Declarations E FB25 z EES F 7 0 UHT PL o ES TIA_PA_Demo_AS 5 FB300 General Part 1 Calls Attributes 70 SFC_ATS g FB1026 0 0 TEST T FCI8 Name Header Mapp Version Header Jo 0 0 TASK Early valve Author Musterma
169. turing formula and processing instructions e Itrecords all measurement and control procedures relevant to the process as actual values e t compares these with the specified target values SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 2 10 2 11 2 12 Requirements of Computer Systems in a GMP Environment Archiving Data Electronic archiving refers to fhe permanent safekeeping of electronic data and records in long term storage The customer is responsible for defining procedures and controls relating to the safekeeping of electronic data Based on predicate rules EU GMP Guidelines 21 CFR Part 210 211 etc the customer must decide how electronic data will be retained and in particular which data will be involved by this procedure This decision must be founded on a sound and documented risk assessment which also takes the relevance of the electronic data over the retention period into account If archived data is migrated or converted the integrity of that data must be safe guarded throughout the entire conversion process Data Backup In contrast to the archiving of electronic data data backups are used to create backup copies that ae the system to be restored in case of original data loss or system breakdown The backup procedure must include the periodic backup of volatile information to avoid total loss of data due to defective system components or inadvertent deletion of data Backup proc
170. ustomized typicals in accordance with design specifications Identifying software modules typicals When software is created the individual software modules must be assigned a unique name a version and a short description of the module Changing software modules typicals Changes to software modules should be appropriately documented Apart from incrementing the version identifier the date and the name of the person performing the change should be recorded when applicable with a reference to the corre sponding change request order SIMATIC PCS7 V7 1 GMP Engineering Manual A5E02795571 01 15 Requirements of Computer Systems in a GMP Environment 2 5 2 5 1 2 5 2 16 Access Protection and User Management To ensure that computer systems in a GMP environment are secure such systems must be equipped with an access control system In addition to physical access control access control systems protect systems against unauthorized logical access Users are assembled into groups which are then used to manage user rights Individual users can be granted access authorization in various ways e A combination of unique user ID and password a description of the confiqura tion can be found in chapter 2 5 2 Requirements of user IDs and passwords e Smart cards together with a password e Evaluation of biometrics Applying access protection to a system In general actions that can be executed on a computer system should be pr
171. ut a safety alert symbol indicates that property damage can result if proper precautions are not taken NOTICE indicates that an unintended result or situation can occur if the corresponding information is not taken into account If more than one degree of danger is present the warning notice representing the highest degree of danger will be used A notice warning of injury to persons with a safety alert symbol may also include a warning relating to property damage Qualified Personnel The product system described in this documentation may be operated only by personnel qualified for the specific task in accordance with the relevant documentation for the specific task in particular its warning notices and safety instructions Qualified personnel are those who based on their training and experience are capable of identifying risks and avoiding potential hazards when working with these products systems Proper use of Siemens products Note the following Siemens products may only be used for the applications described in the catalog and in the relevant technical documentation If products and components from other manufacturers are used these must be recommended or approved by Siemens Proper transport storage installation assembly commissioning operation and maintenance are required to ensure that the products operate safely and without any problems The permissible ambient conditions must be adhered to The information in the rele
172. vant documentation must be observed Trademarks All names identified by are registered trademarks of the Siemens AG The remaining trademarks in this publication may be trademarks whose use by third parties for their own purposes could violate the rights of the owner Disclaimer of Liability We have reviewed the contents of this publication to ensure consistency with the hardware and software described Since variance cannot be precluded entirely we cannot guarantee full consistency However the information in this publication is reviewed regularly and any necessary corrections are included in subsequent editions Siemens AG A5E0279557 1 01 Copyright Siemens AG 2010 Industry Sector 06 2010 Technical data subject to change Industry Automation D 76181 KARLSRUHE GERMANY Introduction Introduction Purpose of this manual This manual describes what is required from the pharmaceutical regulatory viewpoint in Good Manufacturing Practice GMP environment of the computer system the software and the procedure for configuring such as system The relationship between the requirements and implementation is explained with practical examples Target groups This manual is intended for plant operators those responsible for system designs for specific industries project managers and programmers servicing and mainte nance personnel who use the automation and process control technology in the GMP environment Basic knowled
173. y Commissioning and maintenance are also supported by a LifeList program which is able to read field device configura tions online Electronic Device Description EDD EDD forms the basis for device integration It is supplied by the device manufac turer made available via the Internet or included in the device catalogs of EDD applications SIMATIC PDM is fully integrated in PCS 7 All devices integrated in a project using EDD can be parameterized commissioned and maintained from a central engi neering station by means of a single tool Change log The change log in SIMATIC PDM allows you to see at any time which user has made which changes in a project and when This change log function helps to meet the requirements of authorities such as the FDA which demand that changes in the production plant must be appropriately documented so that they can be traced back to their source Access protection in SIMATIC PDM Integrated access protection in SIMATIC PDM manages rights for changing the parameter assignments of field devices In maintenance engineer mode only changes which are required for operation and maintenance may be made in the parameter table Advanced change options are made available in the parameter table for specialists Specialists need to enter a password previously defined in the settings in order to log on User Maintenance engineer Specialist Cancel Bassma Ir DER SIMATIC PCS7 V7 1 GMP E
174. ystem Some settings are always project specific These settings and any changes in response to customer requirements are defined in the specification e The layout of the runtime is configured in the Layout tab This includes the screen formats number of monitors per OS station and the display of the user name or user ID in runtime e Message classes message types message blocks and the PCS 7 standard messages are configured in the Message configuration tab e Messaging response is configured in the Message display tab This includes the display of messages in the message pages and the group display mes sage filters and Smart Alarm Hiding e Under Area the representation of area and server keys for example process cell unit functions etc are configured for the overview area e The number and arrangement of picture windows is configured in the Runtime window tab The pictures graphics and faceplates are opened in the runtime in the picture windows e Inthe Basic data tab you can specify which modified files of the project are to be overwritten by factory state files However you should always ensure when making this configuration change that runtime operation remains consis tent and safe e The General tab contains settings for the OS Project Editor SIMATIC PCS7 V7 1 GMP Engineering Manual 56 A5E02795571 01 Project Settings and Definitions The following screenshot shows the layout of the OS Proje

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