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BioTrends™ User Manual

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1. BioTrends APRIL 2 Create and edit Reports Ar Define Report Results Graphs Microorganisms identification Count T i 7 e LD a SS AD lt a i Kocuria staphilococcus Kokuria Bacillus Microorganisms identification Freq SS Print J Graph on E Data export TI info Lock Time 09 52 E archilex BioTrends ver 2 3 BioTrends reports and statistic amp File Tasks Analysisand Trends View Admin Windows Help E Mail E x r BioTrends a APRIL re Create and edit Reports A A Define Report Results Graphs Microorganisms identification Freq Print A Graph uA 24 06 2009 R 07 10 2009 sms E Data export Z gt Figure 115 Reports and Statistic Histogram and Pie of Microorganism identification Using the graph Toolbar is possible to print the Graph Nome File BioTrends 2 3 User Guide docx 93 104 ferchilex 7 4 Annual report BiolTrends User Guide Environmental Monitoring Software System This function allows the User to print the annual report of selected sampling point The report is made by a description cover and one page with the trend for each sampling point selected In the Trends are showed the alert and action level the number of eventually deviations and the linear regression line To obtain the Annual report select Analysis and Trends gt Annual report from the
2. 38 Figure 44 Insert or Edit Body sampling point 39 Figure 45 Insert or Edit Water Sampling point 39 Figure 46 Insert or Edit Surface Sampling point 39 Figure 47 Insert or Edit Gas Compressed sampling point 40 Figure 48 Insert or Edit Roles of Personnel LL 40 Figure 49 Personnel Data Input i 40 Figure 50 Figure 51 Figure 52 Figure 53 Figure 54 Figure 55 Insert or Edit Raw Material Batch 41 Insert or Edit Product Batch 41 Insert or Edit Culture media batch i 41 Create and Edit Analysis sampling plans 42 Select Type of a new Sampling plan 42 Add elements on a Sampling plan 43 Nome File BioTrends 2 3 User Guide docx BioTrends User Guide Environmental Monitoring Software System Figure 56 Import Maps WINDOW sciscsnsxensscinzexavciavenennesseasremayeesvecatennxeuxeenans 44 Figure 57 Import Maps istructions 44 Figure 58 Import Maps Determine the reference system 45 Figure 59 Area Management renne 46 Figure 60 Area Management Associating an Area i 46 Figure 61 Area Management Save an Area i 46 Figure 62 Area Management Modifying an Area ii 47 Figure 63 Hot Spot Map in Map ie 47 Figure 64 Area Management E
3. Figure 93 Opening List Deviation Reports The list of deviation reports ordered by number will be displayed a 7 Updated 07 02 2012 13 48 01 Samplings Number BiolTrends User Guide Environmental Monitoring Software System Refresh Deviations res Filte e 12 1 8888 10 02 2012 Add Change Print p Expand All Number Opening Date Closing Date Note Status Batch number Area Type Point no Date of control E 14 2011 2011 01 13 Mero 2 Fuori OPEN El 2A11A05 E SRPS1 2 E Superfici E 109 D1 2011 01 05 a 00 00 00 limite superfici El 2A11A05 1 E SRPS1 2 E Superfici E 109 D1 2011 01 05 Species Number Opening Date Closing Date Note Status Batch number Area Type Point no Date of control fi Genus Species m Result t E 17 2011 2011 01 19 2011 01 19 fuori limite sup IMA OPEN E 1A11A10 1 Zanasi E Superfici E MDA7 2011 01 10 fuori limite Micrococcus luteus Number Opening Date Closing Date Note sone Batch number Type Point no Date of control note Genus Species L Result t E 18 2011 2011 01 20 Merol e 2 aria E 1A11A11 E SRPS1 2 E Aria E 109 D1 2011 01 11 00 00 00 109D1 121D103 Classe D E 121 D103 2011 01 11 204AD8 superfici E 204A D8 2011 01 11 109D1 z E Superfici E 109 D1 2011 01 11 E 2A11A11 E SRPS 1 2 E Aria E 109 D1 2011 01 11 Classe D E 121 D103 2011 01 11 E 204A D8 2011 01 11 E Superfici E 109 D1 2011 01 11 muffa genere muffa genere spp
4. rchilex ferchilex Nome File BioTrends 2 3 User Guide docx BioTrends User Guide Environmental Monitoring Software System BioTrends Software Environmental Monitoring Software System BT2 3 Ed 01 Revision 1 February 2012 2 104 Felc N lex BioTrends User Guide Environmental Monitoring Software System No part of this publication may be reproduced or used in any form or by any electrical or mechanical means without permission in writing from Archilex This includes electronic or mechanical means such as photocopying recording or information storage and retrieval systems The material in this manual is subject to change without notice Archilex reserves the right to make changes to any software or product to improve reliability function or design Archilex SA Via al Molino 31 6915 Pambio Noranco Switzerland www biotrends ch Nome File BioTrends 2 3 User Guide docx 3 104 fe rc a OX BioTrends User Guide Environmental Monitoring Software System Revision History Nome File BioTrends 2 3 User Guide docx 4 104 Felc N lex BioTrends User Guide Environmental Monitoring Software System REVISION HISTOR T cm 4 LIST OF FIGURE ciccia 9 I INIRODUC TION cirina E EE E E E Ea EA 11 2 STARIINGIHESOFI NARE iii 12 DM ACCESS TO RE 12 2 1 1 Jr RESHU OCI pito een iena ei eleonora 12 2 1 2 EXP 13 2 1 3 Sace eku i PAsSSWord rien I RO RI NT AI I 13 22 oO e at 14 2 2 1 AUDIO soi TAO I n 14
5. Figure 98 Trend Nome File BioTrends 2 3 User Guide docx 71 104 fe rc a lex BiolTrends User Guide Environmental Monitoring Software System e Zooming an area of the graph Hold down the left mouse button and drag it on the graph to select the area to be zoomed Click on refresh reset to ana go back to the original view e Period of time Set the dates from to and click on refresh reset to to obtain the graph corresponding to the desired period e Scale of values The software determines the scale automatically In order M to customize the display deselect the Automatic check Box and enter the los fd Automatic maximum value for the axis of the unit of measurement J Deviations By default th ftware displ the graph th mb f eviations Dy GeTau e software displays on tne grap e nu ers O the possible deviations Deselect the Show Deviations check Box so as not to display the Deviations Trends Air SRPS 1 Classe C Point 201 C1 When the User click on a sampling point in the graph the box is filled Graph from with the relative information to 05 01 2008 z Max value V Show Deviations refresh reset Points etais Name INCI N 29 08 2007 00 00 00 details Bacteria Mould D a ei a a 25 i i Result 50 i 00 RIE a pay OY 3 ic 4 Q SOG e e LS l ALA gt l gt
6. Figure 8 Quick Access Window Nome File BioTrends 2 3 User Guide docx 15 104 ferchilex 3 2 Menu Options The menu shows as follow File File Logout Exit Tasks Scheduler New gt Sampling Session Deviation Report Tasks Analysts and Trends View Admin Windows Figure 9 Menu options Samplings gt Samplings Media Sampling Sessions Gowning Validation List Deviation Reports Signatures Undo Requests Analysis and Trends Sampling Points Map gt Area Environment gt Department gt Sampling Points Lists gt Environment gt Raw Materials Department gt Finished Products Personnel Gowning Reports and Statistics Annual Report Alarm environmental samplings View Sampling Sessions Admin Audit Trail b Login Changes User Management Lists gt Sampling Plans gt Sampling Plans List Points gt Typology gt Batches gt Air points Body points Water points Surfaces points Compressed gas points Type of Count Type of Method Types of Point Classes of sampling points Type of Raw material Type of Media Type of Device Type of Trend Type of Body points Type of Product Type of Control Type of Area Raw Materials batch Products batch Nome File BioTrends 2 3 User Guide docx Air Surfaces Water Compressed Gas Air Surfaces Water Compressed Gas BiolTrends User Guide Environmental Monitoring Software System Help E Mail 16 104
7. Prior to use the functionality the SMTP setting must be completed by a System Administrator Click on the Settings Tab and fill the information required Figure 129 SMTP Mail Server Nome File BioTrends 2 3 User Guide docx 104 104
8. Culture Media Batch Device Gowning Validation Fa Add Samplings Schedule Go to Today Sampling Session Py Go to Date Change View To gt Statuses Legend gt Add Note In Progress E Completed MI Deleted Approved ml Exit Scheduler Neen eee eT N I EOIQ0 gt M IoeSRNNNNROSDE lt a Tmy gt WYv Weenettt Figure 123 Scheduler functionality Menu 9 1 3 1 Add Sampling Schedule Selecting the Add samplings Schedule option is possible to open a new Sampling Session as a single session or as a recurrency When the option is selected the following window is showed 9 1 3 2 Go to Today This option allows the User to move the selection to today 9 1 3 3 Goto date Clicking on this option is possible to select a specific day and a specific view The following window is displayed for the selection Figure 124 Go To Date selection window Nome File BioTrends 2 3 User Guide docx 102 104 fe rc a lex BiolTrends User Guide Environmental Monitoring Software System 9 1 3 4 Change view To This option allows the User to chang the work area view quickly a Add Samplings Schedule Go to Today bal W Go to Date Ji B Day View ig Add Note E Work Week View F Week View Si Month View O Timeline View Figure 125 Scheduler Change view To gt menu 9 1 3 5 Add Note Using this option it is possible to add a note in the
9. sien Level SAPS 2 Oms C SAPS 3 Omes C GAPS 2 Ome C GAPS I Cisse C Ripa 2 Cisano Ware 3 2 Clee murs i 2 Cime O Tesero Onpersry Caper Capers Cugenang Cugesang Cuposarg da insana Deem perla kame moan varo porene hasie 317 n Box 3 pavimento entrata Box 1 auparfica Silence Gox 3 parete capra la ripr Magazzino SAPS piano senra Nei comeso asc materi Girare 1 marai Graradan 1 Morne Groraian 1 forati Grerudon 1 Morandi Groruderi 1 Morri Greruleri 1 Morar Greruderi 1 Morand Groveton 1 Morand Graralari 1 Maret Gravatar 1 Morri Gravatar i Manuri Gravatar 1 Maret Gracatar 1 Maruri Graala 1 Maret Gratadari 1 Marna reenter 1 Mirari Sampling Points Lists Raw Materials Finished Products Personnel Gowning Reports and Statistics Annual Report Alarms environmental samplings In the list of sampling point showed select one and double click on The Lay out corresponding to the area which the sampling point belong is showed 10 02 2812_1607 DD Number of toms 633 Nome File BioTrends 2 3 User Guide docx D D D Dd p D D d p D D o o p D D d p D D o p D D D p D D D D D D D o p D D Locate Bar tunia mangi Losine Ber Trouble parve Locale Ber Turstier Merete Locale Tia perete vore Locete Get perete sapre Locale Gut perete sopra Locate Get bordo levato Locale Gat pevrrento r Locale Gat pavimento di Locale co
10. Nome File BioTrends 2 3 User Guide docx 100 104 ferchilex 9 1 2 Scheduler Calendar Navigation Allow to move quickly to a specific day It is possible move back and forward by month and year Allow to deselect in the work space view a specific category The legend show the meaning of different color of each sampling session showed in the work space Allow to close and exit the scheduler dk Scheider ps BiolTrends User Guide Environmental Monitoring Software System Calendar Navigation gt m 1 8 15 16 17 18 19 Culture Media Batch Device Gowning Validation Note Sampling Session Statuses Legend MI Not Started In Progress TM Completed MI Deleted Approved Figure 122 Scheduler Calendar Navigation bar Nome File BioTrends 2 3 User Guide docx 101 104 fe rc N lex l BioTrends User Guide Environmental Monitoring Software System 9 1 3 Scheduler Functionality Menu Clicking with the right mouse button on a specific day time cell in the working area the following menu will by showed 2 Scheduler ee ea ighgigh Backward oJ Today a Forward gioco A Zoom Out a Day work weet jwe G3 Month Timeline Group By Type Date None format Hide Show Weekend luned 12 marzo marted 13 marzo mercoled 14 marzo gioved 15 marzo venerd 16 marzo Samplings Types
11. Number Opening Date Closing Date Note Status Batch number Area Type Point no Date of control nee Genus Species esult E 20 2011 2011 01 24 Mero 2 Fuori limite OPEN E 2A11A14 E SRPS 2 Classe C Aria E 311 C1 2011 01 14 Number Opening Date Closing Date Note Status Batch number Area Type Point no Date of control in Note Genus Species esult E 207 2010 2010 11 24 sup A Mero 2 OPEN E 2A10K15 E Linea 2 Classe A E Superfici E 31449 2010 11 15 fuori limite classe A paenibacillus amylolyticus Number Opening Date Closing Date Note Status Batch number Area Type Point no Date of control Note E 208 2010 2010 11 25 aria C mero2 OPEN E 2A10K18 E SRPS 2 Classe C E Aria E 312 C1 2010 11 18 fuori limite 00 00 00 06 30 00 fuori limite Number Opening Date Closing Date Note Status Batch number Area Type Point no Date of control Note E 21 2011 2011 01 27 fuori limite aria OPEN E 1A11A17 E SRPS 1 Classe C E Aria E 203 D1 2011 01 17 fuori limite 00 00 00 classe C E 1A11A19 E Linea 1 Classe A E Aria E 217A144 2011 01 19 fuori limite E 2B11A17 E SRPS 2 Classe C E Aria E 312 C1 2011 01 17 fuori limite Genus Species l Result Genus Species muffa genere spp Kucuria varians 1 Number Opening Date Closing Date Note Status Batch number Area Type Point no Date of control Note Genus Species Result El 212 2010 2010 12 02 aria C D mero 2 OPEN E 2A10K25 E SRP51 2 E Superfici E 114 DI 2010 11 25 fuori limite 00 00 00 Classe D E 300A D2
12. Signatures undo requests to All 0 Fot Area to Calda Andrea I Environment Air i Samplings amp Media s Points to sample last thirty days Media to Read last thirty days ater Compressed Gas Raw Materials Finished Products amp Personnel Gowning Alarms environmental samplings amp 2 Reports and Statistics ee ee ee a Mm 0 9 2 Nome File BioTrends 2 3 User Guide docx 56 104 fe rc a lex BioTrends User Guide Environmental Monitoring Software System 4 In the Sampling Plan list window opened select and double click on the desired sampling plan Acqua purificata P1440 Acqua di rete camosi inversa P1400 RIDOTTO Acqua purificata P1440 RIDOTTO Acqua per inettabil WFI SP4201 Acqua per inettabil WFI Pl420 430 Acqua purificata PI410 campionamento ridotto Acqua puntficata PI410 campionamento completo Vapore puro PI450 Reparto Cispensing ARIA Reparto Effervescent ARIA Raparto Gramulari ARIA Reparto Gramuleri 2 ARIA Reparto IBA ARIA Laboratorio biologico ARIA Laboratoro biologico Meropenem ARIA Locali non classificati ARIA Linea 2 SETUP Linea 2 INIZIO FERETI ERRE eee Linen 2 INIZIO MEDIA FILL Lasa 2 DURANTE MEDIA FILL Linea 2 FINE MEOLA POLL Linea 2 ARIA CONTROLLO COMPLETO Linea 1 Classe C ARIA Linea 1 SETUP MEDIA FILL Lines 1 DURANTE MEDIA FILL Lines 2 Supplementan Anserobi Meda Fil Casse D
13. deselected typology of sampling point will no longer showed on the map Legenda Air Settle Plate Y Air Active Air Sampling B surfaces Surfaces Contact Plate Surfaces Swab O Compressed Gas Water 6 gt S N B Nome File BioTrends 2 3 User Guide docx 74 104 fe rc a lex BioTrends User Guide Environmental Monitoring Software System The view box allows selecting the period and selecting the interactive function View from 11 01 2012 10 02 2012 Er d Tiel Devialioms Detak OF e Trend will display the Trend of the designated sampling point for the selected period e Deviation will show the list of the Deviation occurred in the Area e Detail OFF will highlight the sampling point with alert When Details function is ON is possible to display e The list of the alarm e The report and statistic function applied to a specific Area FT ET Area D ISPErSITIO 7 D EPartm terno LISpersirig 2 r J L d pidhiO fia Gaz oO MeV LZ WITH Area Dispensing gt Department Dispensing gt Map L 2 a piano magazzino Rev 12 wmf Selected point 36b c 1 Atrio v gt 250 ufc m3 gt 500 ufc m3 ion Atrio 1 0 E Legenda Y Air Active Air Sampling surfaces Surfaces Contact Plate 9 Surfaces Swab B Compressed Gas Water ZONA amp ATTESA MAGAZZINO ALTO View from to 1
14. gt 250 ufc gt 500 ufc Aria Conf secondario fine linea BASO dop gt 500 ufc gt 500 ufc Aria Conf secondario fine linea PRX dopo gt 500 ufc gt 500 ufc Aria Blisteratrice 1 entrata vicino bobina P gt 250 ufc gt 500 ufc Aria Blisteratrice 1 pavimento vicino bobin gt 200 ufc gt 300 ufc Superfici Blisteratrice 1 zona recipiente compre gt 250 ufc gt 500 ufc Aria Ricezione merci parte centrale gt 250 ufc gt 500 ufc Aria Nome File BioTrends 2 3 User Guide docx 79 104 ferchilex 7 2 3 Raw Materials Trend Select the option Analysis and Trends gt Raw Materials from the main menu archilex BioTrends ver 2 3 File Tasks Analysis and Trends View Admin Windows Help E Mail E Sampling Points Map Sampling Points Lists In the list of Raw Material showed select one define the period and click on Trends The Trend Biss se Acetilasteina E of the Selected Raw Material will be displayed Acido citrico anidro granulare Acido citrico monoidrato Acido tartarico AcidoDercrocolico acqua deionizzata Acqua per iniettabili WFI Aerosil 200 USP Al idrossido gel secco Amido di patata Antischiuma A F Emulsione Arom limone granuseal 11908 72 arom limone permases 11524 31 Aroma agrumi 585 015 CE Aroma albicocca 11146 Aroma albicocca 11146 7 2 4 Finished
15. 500 ufc m3 94 104 fe rc N OX BioTrends User Guide Environmental Monitoring Software System 7 5 Alarms Environmental Samplings To obtain the Environmental sampling alarm list archilex BioTrends ver 2 3 File Tasks Analysis and Trends View Admin Windows Help E Mail Sampling Points Map 1 Click on the option Tasks gt New gt Deviation Report from the main menu Sampling Points Lists Raw Materials Finished Products Personnel Gowning Reports and Statistics Annual Report Alarms environmental samplings 2 Click on Alarm Environmental samplings from the quick access Toolbar Audit Trail Help Q Info of New Deviation report a Updated 07 02 2012 13 48 01 2 Refresh ff Samplings amp Media i Samplings Number 3 Click on Alarm Environmental samplings or amp sampinssessions ami a2 nia i Signatures undo requests prens sun 339 xceeding Acceptance Limits Exceeding Acceptance Limits in the Quick access mis dar window ETTI 5 ca i _ i Samplings amp Media Points to sample last thirty days 6 i Raw Materials Media to Read last thirty days 6 i Finished Products Ep ERO PRE CSO JR E DE DI 4 Alarms environmental samplings I Egeo ee ie a SS List Deviation reports amp Gowning validation ps E EE SRPS 2 Classe C 2009 02 13 10 30 00 15 ufc 250m2 25 ufo 25cm2 20 02 2009 14 12 02 SRPS 2 Classe
16. N C N C N C N C N C N C N C N C N C N C N C N C N C N C N C N C N C N C Dispensing Dispensing Dispensing Dispensing Dispensing Effervescenti Effervescenti Effervescenti Effervescenti Effervescenti Effervescenti Effervescenti Effervescenti Effervescenti Effervescenti Effervescenti Effervescenti Effervescenti Effervescenti Effervescenti Granulari 1 Monuril Granulari 1 Monuril Granulari 1 Monuril Set the period Default value is the previous year 30dec99 10 10a 10a 11 11 11 12 12 43 43 403 403 403 Figure 116 Annual Report window Obtain the Annual Report gt 250 ufc m3 gt 250 ufc m3 gt 250 ufc m3 gt 250 ufc m3 gt 250 ufc m3 gt 250 ufc m3 gt 250 ufc m3 gt 250 ufc m3 gt 250 ufc m3 gt 250 ufc m3 gt 250 ufc m3 gt 250 ufc m3 gt 250 ufc m3 gt 250 ufc m3 gt 250 ufc m3 gt 250 ufc m3 gt 250 ufc m3 gt 250 ufc m3 gt 500 ufc m3 gt 500 ufc m3 gt 250 ufc m3 gt 250 ufc m3 gt 250 ufc m3 i gt 500 ufc m3 gt 500 ufc m3 gt 500 ufc m3 gt 500 ufc m3 gt 500 ufc m3 gt 500 ufc m3 gt 500 ufc m3 gt 500 ufc m3 gt 500 ufc m3 gt 500 ufc m3 gt 500 ufc m3 gt 500 ufc m3 gt 500 ufc m3 gt 500 ufc m3 gt 500 ufc m3 gt 500 ufc m3 gt 500 ufc m3 gt 500 ufc m3 gt 500 ufc m3 gt 500 ufc m3 gt 500 ufc m3 gt 500 ufc m3 gt
17. The available reports are Complete Report all the information showed are printed result statistics trends and histograms Summary the report is available only if are displayed the Statistics The report shows the histogram of total result and the numeric value If the option Alert Suggested is ON the value of the suggested alert is showed in the Summary report Results frequency Summary the report is available only if are displayed the Values Frequency The report shows the histogram and the table of values Batch Summary to obtain the report in the filter must be added only a product batch number In any case if the criteria are not meted a message box is showed Data Export allows the user to export the selected data in a HTML file Once the report has been selected click on the L key Select the desired printer and click on OK The reports can be printed as a PDF file Nome File BioTrends 2 3 User Guide docx 91 104 ferchilex 7 3 5 Reports and Statistics Microorganism Identification statistics The Report and Statistic gt Microorganism Identification tab is divided in three main parts BiolTrends User Guide Environmental Monitoring Software System archilex BioTrends ver 2 3 BioTrends reports and statistic File Tasks Analysisand Trends View Admin Windows Help E Mail Results 12 Genus of identified microorganisms _ Alicyclobacillus acidoterrestris Bacillus amyloliquefaciens fusifo
18. gt Users Management f 9 Users management Filtra Lista per i User ID Status Email biotrendsadmin Enabled Figure 12 User Management window The system is supplied with a predefined user with administrator privileges user ID biotrendsadmin password biotrendsadmin Access the software with this user ID to define other users Every user will be given a password by the administrator users will be forced to change such password the first time they log on the system Nome File BioTrends 2 3 User Guide docx 21 104 felrchilex 4 1 1 Each type of users has different levels of access The permissions for each level have reported in the followings tables 4 1 2 1 2 3 4 4 1 3 1 2 3 4 BioTrends User Guide Environmental Monitoring Software System Level of User access Administration and Configuration Functions PR Scheduling activity open a sampling session and Approval a sampling session Data entry and closing a sampling session GP E Er TRIPPA The function Admin gt Option Management is available only for BioAdmin Defining a new user Click on the option Add from the Users Management window menu Fig 9 the window to enter the new user data will be displayed Users Data input z Users management User ID Password Confirm password Email Role bioSupervisor oi Password Expiry H un 4 o eT Allowed Passwords no
19. lex BioTrends User Guide Environmental Monitoring Software System 3 4 Quick Selection box The Quick Access windows functionalities can be shows as not a pop up in the Quick selection box by click on the blue arrow in the left side of the Main Window archilex BioTrends ver 2 3 File Tasks Analysis and Trends View Admin Windows Help E Mail BioTrends A archilex BioTrends ver 23 File Tasks Analysis and Trends View Admin Windows Help lastthirty days Signatures undo requests to Al to Calda Andrea i Samplings amp Media Points to sample last thirty days i lastthi oo oo oo oo W2 Personnel Gowning A Alarms environmental F Reports and Statistics List Deviation reports Gowming validation Figure 11 Main window with quick selection The functionalities showed as same as in the Quick Selection Window Nome File BioTrends 2 3 User Guide docx 19 104 le rc N CX BioTrends User Guide Environmental Monitoring Software System 3 5 Status Bar archilex BioTrends ver 2 3 ole 8 File Tasks Analysis and Trends View Admin Windows Help E Mail BioTrends ne Lock Time 59 04 Signatures undo requests 1 O info amp LockTime 59 36 3 Signatures undo requests 1 On the status bar are showed the following information e Info PC Client name User Level SQL Server SQL Catalog e Lock Time is the time left before the automatic Logout O O O e
20. 2 2 2 ENdNO Me WOK SeSS0 lg 14 3 _MAINWINDOW cinia riali 15 dal A QUICKAGCESS WINGOW cinici ina aaa iaia Area cleaner pirata 15 32 Menu Opiions arene 16 43 QUICK ACCESS TOOIDAF saioa a a 18 SA QUICK SCIOCCHON BOX sviene aaa conii laine 19 29 SaS 20 4 GETTING STARTED ADMINISTRATION AND CONTROL FUNCTIONS 21 AT User Management esisin aaa a E Eai 21 4 1 1 Level of User FACCE sre eid ce cena ow bem tasonetoesim TL n 22 4 1 2 EJ STING OW WSOP ira i O E tI Ir 22 4 1 3 ChaAAgng Users DOD O Cee ee eee ae tee ene ee ere eee eee ee ee eee 22 4 1 4 EFS A IAS OO rset rte aes casino skea A E tet neaattgnenstaetedtnaioabaensiutadenattenennauniqdian tea A S 23 4 1 5 AMIN AU 23 4 1 6 DCIS UNG a User lla ni irpini arri 23 4 1 7 FISSWONATESE E RT ROTA AIA DTT LAN a 23 42 BaSe DaD Eep A cai 23 4 2 1 List Window Description cricca aio 24 4 2 1 1 Adding a new element to the list iii 24 4 2 1 2 Changing the attributes of an eleMent iii 24 42 10 PAAA a e a E E ee E E E ET EE AE EE EEE AE E ETETE 24 Nome File BioTrends 2 3 User Guide docx 5 104 Felc N lex BioTrends User Guide Environmental Monitoring Software System 42 44 penali 25 42 9 PKIN CONS WG lara 25 4 2 2 FCS TINS Gl OI rana ot ar I IT Te 26 42AT Unt ormedsure bacon n 27 4 2 2 2 Acceptance Leverano 28 42253 TOO U aeara aera E E A EN EE A E EN E E E A ENA EE A E Gi 28 42 24 Type ol methodes nE E EE E
21. 2010 BASE_20100610151555 wmf A 9 ji T IBA vuote NON USARE piano Predusione ip 2_20080910213930 nef E Monuril Granuani n L 3 a piane Produzione Rev t1 maf L 3 a piano Produzione Rev 11 mmf piano Predunone ip 2_20080910213930 mnt 1 2 a panc magazano Rev 12 wmf is L 3 a pano Sroduzone Rev 11 mf Ti Granieri 2 Vecchio Layout r 2 L 3 a piano Produzione Rev 11 maf o 10 02 2012 1429 Area Dispensing gt Department Dispensing gt Map L 2 a piano magazzino Rev 12 wmf Select an Area The corresponding Lay out will be showed See Map General function Legenda ZONA ATTESA MAGAZZINO ALTO Nome File BioTrends 2 3 User Guide docx 76 104 ferchilex 7 2 1 2 By Environment Select the Environment desired B archilex BioTrends ver 2 3 File Tasks Analysis and Trends View Admin Windows Help E Mail In the list of sampling point showed select one and double click on The Lay out corresponding to the area which the sampling point belong is showed 7 2 1 3 By Department Select the Department desired GB archilex BioTrends ver 2 3 Sampling Points Map Sampling Points Map Sampling Points Lists Raw Materials Finished Products Personnel Gowning Reports and Statistics Annual Report Alarms environmental samplings Surfaces p Biolrends User Guide Environmental Monitoring Software System ints Map
22. 279 SRPS classe DA 279 SRPS classe D A 279 SRPS classe DA 279 SRPS classe DA 279 SRPS classe DA 279 SRPS classe D A 279 SRPS classe DA 279 SRPS classe DA 279 SRPS classe DA 279 SRPS classe DA 279 SRPS classe DA 279 SRPS classe DA 279 SRPS classe D A m 279 SRPS classe D A 279 SRPS classe O A 279 SRPS classe D A SRPS 1 2 Classe D SRPS 1 2 Classe O SRPS 1 2 Classe D gt 70 ufc m3 gt 70 ufc m3 gt 70 ufc m3 m gt 100 ufc m3 gt 100 ufc m3 gt 100 ufc m3 Acceptable Acceptable Results Acceptable 16 07 2009 14 32 00 16 07 2009 14 32 00 16 07 2009 14 32 00 1A09G16 Meropenem 1000 mg 2 1A09G16 Meropenem 1000 mg 2 1A09G16 Meropenem 1000 ma 2 Spogliatoio sotto flusso lami Corridoio tra due porte spog Spoaliatoio sotto flusso lami 9000000000000 000 090 onpoCOaRPRHOhMNOhOmMMOO N occocccoccococaoecoaco ocou THON HHEHHHHHHHHHH YY YH HIO Results Statistics Total Count by Date Point 109 01 107 02 107 05 111 01 8 8 o 02 07 2009 o 08 07 2009 40 16 07 2009 o 23 07 2009 o 29 07 2009 o 26 08 2009 o 02 09 2009 o 08 09 2009 4 17 09 2009 96 24 09 2009 4 30 09 2009 o 07 10 2009 o tfoofoofofosoc0o0 3 Es aofaoococoof ao w x aR aakeooaoana Print complete report Print Summary Print results frequency Summa Print Batch Summary E Totalcount v Print 3 ColX2 Row v
23. 29 89 0 0 50 50 100 50 50 10 Values greater than zero 118 2 2 1 1 0 2 1 9 Values greater than zero 67 82 100 100 50 50 0 50 50 90 Alert Level N A gt 70 ufc m3 gt 70 ufc m3 gt 70 ufc m3 gt 70 ufc m3 gt 70 ufc m3 gt 70 ufc m3 gt 70 ufc m3 gt 70 ufc m3 Alerts no 3 0 0 0 0 0 0 0 0 Alert 1 72 0 0 0 0 0 0 0 0 Action Level N A gt 100 ufc m3 gt 100 ufc m3 gt 100 ufc m3 gt 100 ufc m3 gt 100 ufc m3 gt 100 ufc m3 gt 100 ufc m3 gt 100 ufc m3 Actions no 1 0 0 0 0 0 0 0 0 Action 0 57 0 0 0 0 0 0 0 0 m r Microorganisms dy Alert suggested v Values Frequency amp Prit 3ColX2Row fg CR EEEE ET TI ca Info Q Lock Time 09 58 4 A Figure 110 Report and statistic Statistic of result The first column shows the statistics for all the selected point Using the Statistics toolbar is possible Microorganisms dia Alert suggested Values Frequency Print 3 Col X 2 Row a b C d e a Display the Microorganism found by Date Point Click on Statistics to go back at the statistics view Results Statistics Microorganisms Count by Date Point pate soa D1 202 01 301 03 123 03 111 01 122 01 120 01 309 01 20401 a I YO Cece SE na Sd 26 08 2009 27 08 2009 27 08 2009 28 08 2009 28 08 2009 31 08 2009 31 08 2009 01 09 2009 02 09 2009 muffa genere aspergillus spp 1 muffa genere aspergillus spp 1 02 09 2009 03 09 2009
24. ARIA CONTROLLO COMPLETO Cassa D ARIA CONTROLLO GIORNALIERO Linen 1 INIZIO DI Numberoitems 79 d 5 BioTrends requires to electronically signing the operation by input User ID and Password Then click on User ID biotrendsadmin Password ESET TES Meaning Opening of a sampling session 6 After signing it the data entry card corresponding to the chosen sampling plan will be displayed fill in the fields setting sampling date time designed operator and any information is required at this time 7 Before closing the Sampling session the User may select deselect sampling point in the list by click unclick the check box if knows in advance that the sampling point will not be sampled At M 26b 1 the end close the sampling session by click on ME 252 1 36c close key WW 26b c 1 36b c W 264 1 36d 364 2 36d Figure 77A B C D E F G New Sampling session procedure 5 1 1 2 From the Scheduler See Scheduler chapter Nome File BioTrends 2 3 User Guide docx 57 104 fe rc a lex BioTrends User Guide Environmental Monitoring Software System 5 1 2 List of Sampling sessions in progress and or completed This functionality allows the User to review the list of Sampling sessions according with their status To open the list follows one of the forward methods 5 1 2 1 From the menu ae archilex BioTrends ver 2 3 ia 1 Toviewthe list of the sampling sessions opened in progre
25. Add to Custom Colors ey x Cancel Apply Figure 67 Options window Color Acceptance levels 4 6 2 Data Input lt can be used to specify whether or not to apply the conversion formulas indicated in the list to the sampling measurements the default duration of sampling plate incubation and the default temperatures at which they are incubated It is possible to set the following parameters W Files Folders Expiring periods Customizable Fields Description A Data Input Automatic Log Off Colors of acceptance levels Application Signatures reasons Options F PDA Data Input Password Length min Statistical Conversion Normalize to a cubic meter Length incubation 1 h 48 Length incubation 2 h 72 48 22 24 C de 22 24 C Length incubation 3 h Temperature incubation 1 Temperature incubation 2 Temperature incubation 3 ofthe Soerensen table forthe air samplings Hi Ok Allows to set some parameters used by the software when Sampling Data will be putin such as the statistical use Cancel Appy Edit D Figure 68 Options window Data Input Nome File BioTrends 2 3 User Guide docx 50 104 I ferc a OX BioTrends User Guide Environmental Monitoring Software System 4 6 3 Expiring Periods It is possible to set the following parameters Indicates how many days in advance f
26. Approve the same sampling session The signature is facultative 5 1 5 Changing a sampling session data Changing the data of the sampling results is an operation that can be performed by bioAdmin bioSupervisor and bioMaintainer users see User Management Depending on the sampling session status changing data may be free or may require following the Signature Undo request procedure 5 1 5 1 Changing data in a Sampling session In Progress Open the sampling session which data need to be modified by using one of the methods explained in the section List of Sampling session Click on the specific field change the information or the incorrect data and close the sampling session The change is automatically saved and is reported in the Audit Trail Nome File BioTrends 2 3 User Guide docx 60 104 fe rc N lex BiolTrends User Guide Environmental Monitoring Software System 5 1 5 2 Changing data in a Sampling session Closed or Closed and Approved Open the sampling session which data need to be modified by using one of the methods explained in the section List of Sampling session Click on the specific field The following message will be showed If click on Yes the Signature Undo request procedure will be applied to the sampling session if click on No the message will close and the datum will not be d Analysis session is closed
27. BioTrends 2 3 User Guide docx 54 104 fe rc a OX BioTrends User Guide Environmental Monitoring Software System 5 Tasks Environmental monitoring activities may be assigned to single operator and programmed in advance Operators can get updated information about the tasks they have been assigned by checking the lists from the Tasks menu E archilex BioTrends ver 2 3 File Analysis and Trends View Admin Windows Help E Mai Scheduler New gt Samplings g Gowning validation List Deviation reports Signatures undo requests Figure 76 Tasks menu By checking these same lists analysts will know when the sampling plates have to be read and in which incubator they are The term Sampling session that is used in this release indicates the activities that are generated when it is decided to start the sampling and analysis procedures in a sampling plan A sampling session will be considered to be completed when a manager affixes his signature to Close Session The data from a completed session will thus become official and will appear in the trends and reports Nome File BioTrends 2 3 User Guide docx 55 104 fe rc N OX BioTrends User Guide Environmental Monitoring Software System 5 1 Sampling The laboratory manager may plan the sampling work by programming the corresponding activities through the Sampling sessions The Sampling Sessions may be done as a daily activity or scheduled as weekly or monthly a
28. C 2009 02 13 10 30 00 15 ufc 250m2 25 ufa 25cm2 20 02 2009 14 12 02 SRPS 1 2 Clas 2009 02 12 13 00 00 30 ufe 25en2 50 ufe 25em2 24 02 2009 14 03 19 SRPS 1 2 Clas 2005 02 12 13 00 00 30 ufc 250m2 50 ufc 25cm2 24 02 2009 14 03 19 2009 02 09 21 50 00 1 ufc guanto 1 ufc guanto 24 02 2009 11 30 01 Linea 2 Classe A 2009 02 09 20 40 00 1 ufc 250m2 2 ufa 25cm2 20 02 2009 14 00 55 SRPS 1 Classe C 2009 02 09 10 45 00 15 ufe 25en2 25 ufe 25cm2 20 02 2009 13 57 50 2009 02 09 08 00 00 3 ufc 250m2 5 ufc 2Scm2 24 02 2009 11 20 39 2009 02 09 08 00 00 3 ufc 250m2 5 ufo 25cm2 24 02 2009 11 20 39 Zanasi 2009 02 09 00 00 00 1 ufc 250m2 2 ufa 25cm2 24 02 2009 09 41 38 Acqua 440 2009 02 05 13 00 00 50 ufe mi 100 ufe mi 02 03 2009 14 51 41 SRPS 1 2 Clas 2009 02 03 13 00 00 30 ufc 250m2 50 ufc 25cm2 10 02 2009 15 46 41 SRPS 1 2 Clas 2009 02 03 13 00 00 30 ufc 250m2 50 ufo 25cm2 10 02 2009 15 46 41 SRPS 1 2 Clas 2009 02 03 13 00 00 30 ufc 250m2 50 ufa 25cm2 10 02 2009 15 46 41 SRPS 1 2 Clas 2009 02 03 13 00 00 30 ufc 250m2 50 ufe 25cem2 10 02 2009 15 46 41 IMA 2009 02 03 08 14 00 1 ufc m3 2 ufc m3 11 02 2009 15 26 14 2009 01 30 00 00 00 3 ufc 250m2 5 ufo 25cm2 09 03 2009 11 13 47 SRPS i 2 Clas 2009 01 29 14 19 00 30 ufc 250m2 50 ufe 25cm2 06 02 2009 09 30 29 SRPS 1 2 Clas 2009 01 29 14 19 00 30 ufc 250m2 50 ufe 25cm2 06 02 2009 09 30 29 2009 01 28 11 85 00 3 ufc 2San2 ufc 2Scm2 06 02 2009 17 03 24 2009 01 28 09 05 00 3 ufc 250m2 5 ufo 25cm
29. Contr ind Controllo indumenti Lines 2 282 Contr ind Controllo indumenti Linea 2 282 Contr ind Controllo indumenti Lines 2 282 Contr ind Controllo indumenti Linea 2 42 Contr nd Controllo indumenti Lines 1 42 Contr ind Controllo indumenti Linea 1 42 Contr ind Controllo indumenti Lines 1 126 Laboratorio biologico LS ARIA 42 Contr nd Controllo indumenti Lines 1 42 Contr ind Controllo indumenti Lines 1 42 Contr ind Controllo indumenti Linea 1 42 Contr nd Controllo indumenti Lines 1 282 Contr ind Controllo indumenti Linea 2 202 Contr ind Controllo indumenti Lines 2 126 Laboratorio biologico LS ARIA 148 Granulan 2 148 Granulari 2 148 Granulen 2 144 Controlla acqua punficata P 400 Settimanale 144 Controlla acqua punficata PI 400 Settimanale 144 Controlla scqus punficata Pf 400 Settimanale 144 Controlla acqua punficata PI 400 Settimanale 144 Controlla acqua punficata PI 400 Settimanale 144 Controlla acqua purificata PI 400 Setti 146 Controllo scqua punficata PI 440 Settimanale 146 Controllo acqua purificata PI 440 Settimanale 144 Controlla acqua punficata PI 400 Settimanale 146 Controllo acqua punficata Pf 440 Settimanale 146 Controllo acqua punficata PI 440 Settimanale 146 Controllo acqua punficata PI 440 Settimanale 146 Controllo acqua punficata PI 440 Settimanale 144 Controlla scqua punficata PT 400 Settimanale 144 Controlla
30. E E DE EEE E E E E 29 4225 POE OF PON aa E E E EE E E E AEE E 29 4 2 2 6 Classes of sampling PON 30 ALL U E E E E O E A E OTENE A E O EE E A eee O eee 30 4 2 2 8 Type of Raw Material iii 30 422 IPER inni rai 31 4 2 2 10 Type Of DEVICES 31 A2211 Typeol Body DNS 31 422 12 Type Ol PTOdUGIS inca 32 4225 T OU COOL olo la I E A R 32 Aa a TEO Alli 33 42219 DeparnmeniS sereen ene i 33 EO Pci E S E tit 34 220 Rana 35 42 2 0 SPEC BIG 35 422 19 Additonal iiO ieri 36 42 22 Desa ee E E E E E E eee ee 36 97004744 A CERRI 37 42 222 INS la 37 42 2 23 Standard VOIUME EXDOSUNE TIME eee 38 asa A 11 1g 6 L019 DON oe ee nee ee ene ee eee 38 42 225 Rol s ofthe Personnel in 40 4 2 2 26 Personnel Management ii 40 4 2 2 27 Raw Material Batches iii 41 4 2 2 28 Finished Product Batches iii 41 42229 UIP media DA sssini r Aexqansesienctandes gaceneee R EA E EER eR ea 41 42250 ON O a ara 42 4 3 Company maps OF Layouts a E EE AE 44 4 3 1 IMPONG NAV OUNS oriali sla 44 4 3 2 PEEN N E EM E E E A OEN 46 4 3 2 1 Associating an Area for the first tiMe ii 46 4 22 NOIA GGOA piro e eroe 47 4 35 23 HotSpot MAPPE 47 4 3 24 Entering the Sampling Ppomis s ieri 48 AA Signature REDON csrsissinnr aiai aE Eaa aiai 48 4 5 Deviation Reports Management sanare 49 4 6 Options configurable parametes sscccccsssssccccssssscccccssssce
31. Figure 111 Reports and Statistic Trends of sampling results 88 Figure 112 Reports and Statistic Histogram of Statistic 89 Figure 113 Reports and Statistic Histogram and Pie of Values frequency CERERE 90 Figure 114 Microorganism Identification WINDOW s es 92 Figure 115 Reports and Statistic Histogram and Pie of Microorganism identica RR SRO RR TRATTA 93 Figure 116 Annual Report WindoW iii 94 Figure 117 Alarm Environmental Samplings LiSt 95 Figure 118 List Windows with Print Barcode function active 96 Figure 119 Print Barcode functionality 96 Figure 120 Scheduler main WindoW iii 98 Figure 121 Scheduler TOO Dalai aan 99 Figure 122 Scheduler Calendar Navigation bar 101 Figure 123 Scheduler functionality MENU 102 Figure 124 Go To Date selection WwWINdOW sssssssssrsrsrsssrsrsrrrererrsrrersens 102 Figure 125 Scheduler Change view To gt MENU 103 Figure 126 Scheduler Add Note WINdOW LL eee eee eine 103 Figure 127 Scheduler reminder WINdoW LLL iii 103 Figure 128 EMail 104 Figure 129 SMTP Mail Server i 104 Nome File BioTrends 2 3 User Guide docx 10 104 Felc N lex BioTrends User Guide Environmental Monitoring Software System 1 Introduction BioTrends is a software system developed for managing microbiological data and laboratory activ
32. H Graph S Print K Graph info Lock Time 09 52 Figure 114 Microorganism Identification window The part A is a list of all microorganism found The total number of microorganism is indicated in the right top corner a It is also possible filter the list using the drop down menu Filter result by b Clicking on one of any column head the drop down list will be willed with the information present in the column Use the key refresh to clear the effect of the filter The part B is the list of Genus with the total count the frequency of isolation and relative percentages By clicking on one of any column head it is possible to list the result in crescent or reverse order Selecting a specific Genus the box C is filled with the Detail of Species As for the box B is possible to order the result Using the toolbar in the box B and C it is possible Print Graph a Print the list b Obtain a Graph Nome File BioTrends 2 3 User Guide docx 92 104 ferc a lex BioTrends User Guide Environmental Monitoring Software System 7 3 5 1 GRAPH from Statistic of Microorganisms investigation In the microorganism identification window result click on to obtain the graphs of count and frequency of identification E archilex BioTrends ver 2 3 BioTrends reports and statistic amp File Tasks Analysisand Trends View Admin Windows Help E Mail oI x
33. Monitoring Software System 4 5 Deviation Reports Management The Deviation report can be used to display the list of all the deviation opened in BioTrends Select the option Admin gt Deviation report from the main menu archilex BioTrends ver 23 pe 22 File Tasks Analysis and Trends View Admin Windows Help E Mail Audit Trail BioTrenAmee gt Lists ii Factory Maps amp Deviation reports Signatures Report Options The list of all the Deviations will be displayed See Deviation Report 4 6 Options configurable parameters In BioTrends some parameters can be configured by users with bioAdmin authorization level See User Management To access to the Options window click on the menu Admin gt Options archilex BioTrends ver 23 File Tasks Analysis and Trends View BioTrenPf The Option window will be showed Options amp Automatic Log Off Customizable Fields Description W Files Folders Application A PDA Colors of acceptance levels E Data Input Expiring periods Signatures reasons Colors of acceptance levels Edit Alert Level 16711680 Action Level 255 Values greater than zero 65280 Show a message the value exceeds the acceptanc True PT Allow to set the displayed colors in the sampling values which exceeding acceptance criteria ki Ok EPCancel Apply Figure 66 Options window Select the type of
34. Motivation of data change the change write the motivation and To finish the starting of the Signature undo request procedure an explanation must be inputted in the relative box showed after the above actions and then click on Save The recipients of the request are informed about it by means of a visual notice e Atthe bottom right corner of the status bar oo io Lock Time 59 59 24 Signatures undo requests 1 0 im uamea D ayete regse t inizia Win a Updated 07 02 2012 11 49 20 2 Refresh i 4 New Sampling session i Samplings Number New Deviation report 2012 off Samplings amp Media 2011 82 339 amp Exceeding Acceptance Limits Alert last thirty days 8 Action last thirty days I Sampling sessions Signatures undo requests A Trends i IJ Sampling Points Ei Area 3 fe Signatures undo requests to All 1 to Calda Andrea 1 i Samplings amp Media Paints to sample last thirty days 6 Media to Read last thirty days 6 i i Compressed Gas i Raw Materials i Finished Products i Personnel Gowning amp Alarms environmental samplings E Reports and Statistics WP sriimiciodi du Figure 83A B C D E Signature Undo request procedure Nome File BioTrends 2 3 User Guide docx 62 104 ferc a lex l BioTrends User Guide Environmental Monitoring Software System 5 2 1 Signature Undo Requests List To open the Signature Undo request list follo
35. SRPS 1 2 Classe D gt 70 ufc m3 gt 70 ufe m3 gt 70 ufc m3 gt 70 ufc m3 gt 70 ufc m3 gt 70 ufe m3 gt 70 ufc m3 gt 70 ufc m3 gt 70 ufc m3 gt 70 ufc m3 gt 70 ufc m3 gt 70 ufc m3 gt 70 ufe m3 gt 100 ufc m3 gt 100 ufe m3 gt 100 ufc m3 gt 100 ufa m3 gt 100 ufc m3 gt 100 ufe m3 gt 100 ufc m3 gt 100 ufc m3 gt 100 ufc m3 gt 100 ufc m3 gt 100 ufc m3 gt 100 ufc m3 gt 100 ufe m3 on o efoseasnce Acceptable Acceptable Acceptable Acceptable Acceptable Acceptable Acceptable Acceptable Exceedin Acceptable Exceedin Acceptable Acceptable Results Results Results Results Results Results Results Results Results 25 06 2009 14 20 00 25 06 2009 14 20 00 25 06 2009 14 20 00 02 07 2009 15 00 00 02 07 2009 15 00 00 02 07 2009 15 00 00 02 07 2009 15 00 00 02 07 2009 15 00 00 08 07 2009 13 57 00 08 07 2009 13 57 00 08 07 2009 13 57 00 08 07 2009 13 57 00 08 07 2009 13 57 00 2A09F25 Meropenem 1000 mg 1A 2A09F25 Meropenem 1000 mg 1A 2A09F25 Meropenem 1000 mg 1A 2A09G02 Meropenem 1000 mg 1 2A09G02 Meropenem 1000 mg 1 2A09G02 Meropenem 1000 mg 1 2A09G02 Meropenem 1000 mg 1 2A09G02 Meropenem 1000 mg 1 1A09G08 Meropenem 1000 mg 2 1A09G08 Meropenem 1000 mg 2 1A09G08 Meropenem 1000 mg 2 1A09G08 Meropenem 1000 mg 2 1A09G08 Meropenem 1000 mg 2
36. Signature undo request n the message appear only if the user logged has a Signature Undo request See Signature Undo Nome File BioTrends 2 3 User Guide docx 20 104 fe rc N OX BioTrends User Guide Environmental Monitoring Software System 4 Getting Started Administration and Control Functions In order to start using BioTrends it is necessary to get it ready by loading basic information such as sampling points acceptance levels the types of culture media used etc Configure the User and the related access level Some difficulties may arise during this initial phase in which information will be loaded in the database A precise order must be followed otherwise the preparation work might experience delays In BioTrends many types of data are made up of a label and a series of attributes Some attributes cannot be freely specified they must be chosen from predefined lists in order to avoid typing errors and the data unserviceability for searches in the database In case of entering a datum that requires a specific attribute from a predefined list and the necessary desired value is not present in the list it will not be possible to save the datum it will be first necessary to close the regular data entry window in order to open the predefined list and record the necessary element The most important data type in BioTrends is the Sampling Point It may be erroneously thought that the first thing to be done is saving the
37. a given period for a given Area Class etc or to obtain the Bioburden of the entire Company or part of it To display the Create and Edit Reports window select the option Analysis and Trends gt Reports and Statistics from the main menu The display of Trend graphs is limited to 64 elements ag archilex BioTrends ver 2 3 File Tasks Analysis and Trends View Admin Windows Help E Mail i Sampling Points Map Sampling Points Lists Raw Materials Finished Products Personnel Gowning Reports and Statistics Annual Report Alarms environmental samplings Reports and Investigations by Environment o mi RITI Y Departments Ge Cheer x i Y Microorganisms e e dx ad Re a No mems found Try to chang ur 27 01 2012 Fg 10 02 2012 v Statistics of sampling results Figure 108 Reports and Trends window Nome File BioTrends 2 3 User Guide docx 82 104 fe rc a lex BioTrends User Guide Environmental Monitoring Software System 7 3 1 Report and Statistics Define a Report To obtain a specific report it is necessary to follow some further steps Select the type of report Reports and Investigations by Environment or Reports and Investigations by Personnel The List at the bottom will show the corresponding sampling points and either all the environmental sampling points air surface water compressed gases or the points of the body Narrow the field of the investigation to limit
38. acqua purificata PI 400 Settimanale 146 Controllo scqus punficata PI 440 Settimanale 10 02 2012 1226 Nome File BioTrends 2 3 User Guide docx 24 02 2010 11 25 00 24 02 2010 13 00 00 24 02 2010 14 45 23 24 02 2010 18 40 00 04 01 2010 22 00 58 20 03 2010 14 26 38 15 02 2010 01 20 42 15 03 2010 16 20 40 15 03 2010 16 28 18 18 03 2010 14 19 09 19 02 2010 10 34 09 39 03 2010 13 35 12 19 03 2010 13 22 06 Apertura sessione di campionamento Apertura sessione di campionamento Apertura sessione di campionamento Apertura sessione di campionamento Apertura sessione di camgiionamento Apertura sessione di camquonamento Chiusura Sessione di campionamenti Apertura sessione di camguonamento Chiusura Sessione di campionamenti Agprovazione Sessione di campionamenti 19 03 2010 19 30 36 20 03 2010 09 06 33 24 03 2010 11 32 22 25 03 2010 08 35 17 25 03 2010 08 41 15 25 03 2010 08 43 39 25 03 2010 08 45 33 25 03 2010 14 56 13 25 03 2010 15 03 45 23 03 2010 15 06 32 25 03 2010 15 07 50 23 01 2010 15 33 15 25 03 2010 15 36 25 25 03 2010 15 38 11 25 03 2010 15 40 33 25 03 2010 15 41 56 25 03 2010 15 43 28 25 03 2010 16 23 37 23 03 2010 16 25 55 26 03 2010 10 55 20 26 03 2010 10 36 31 26 03 2010 10 56 54 26 03 2010 11 04 17 Approvazione Sessione di campionamenti Apertura sessione di campionamento 23 Number ot ams 31388 Figure 65 Signature report list 48 104 fe rc a lex BioTrends User Guide Environmental
39. and the types of media that should be used the sampling plan will always be available for the system users who will call it up every time it is necessary to start a new sampling session and it will be displayed as it is shown in the figure below A sampling plan can be kept as a Draft until it is enabled or may become obsolete and therefore disabled Sampling plans can be sorted into the following groups e Air Surfaces Water Compressed gases Environmental controls will involve a series of points belonging to the same group i e it will not be possible to specify Air and Surface points simultaneously in the same environmental sampling plan e Checks on Personnel will involve a series of points of the body or clothing such as forearms gloves etc and they may be further divided into checks on the sterilization of clothing checks on operators and Gowning validations e Checks on Raw materials according to the type of substance will also include specific bacteria and their acceptance levels e Checks on Finished products according to the type of product will also include specific bacteria and their acceptance levels To enter a new sampling plan click on the option Add from the window menu the screen to enter the sampling plan data will be displayed Lal Analysis sampling plans Create and Edit Analysis sampling plans Basie data I Type Department Number S O P Schedule Title Richiedi firma operatore Cibi F
40. as well as the time Li Ok EPCancel Apply di Figure 71 Options window Automatic Log Off 4 6 6 Customizable field description It is possible to specify the description of the following fields Colors of acceptance levels E Data Input Automatic Log Off Customizable Fields Description Options Expiring periods Signatures reasons A PDA I FilesFolders Application Customizable Fields Description Additional Information sampling pages Devices such Air Samplers incubators etc Description to use for the Fungi fields es Molds and Yeasts Additional description in Campaign Schedule Devices Fungi and Yeast Allows to specify the labels of some database field used as a general information Es You may rename the field ka Ok Cancel Apply Edit D Figure 72 Options window Customizable field description Nome File BioTrends 2 3 User Guide docx 52 104 fe rc a lex BioTrends User Guide Environmental Monitoring Software System 4 6 7 Files Folder It is possible to specify the path of the temporary folder where BioTrends may save the temporary files The folder must be accessible in Read Write and Modify Options Colors of acceptance levels E Data Input Expiring periods Signatures reasons amp AutomaticLog Off Customizable Fields Description Files Folders Application PDA Files Folder
41. di i gt SSE 5 A 5 lA 5Z gt 5 SESS SS i nk mene es e i i j i x 3 ov e F LT Te na BEER dl EE EEE i i EA LL LL EE EE Ee Se ee a ni a ni Ba at OOO OOO OGG OGG OSIO COSO O OGG OOO ORO CAIO OO A A N A 5 e i O O arene ee ee ee eae i f gt F Nome File BioTrends 2 3 User Guide docx Figure 33 Department Area Room hierarchies n a ne i er n fees net teen eni i ren tei nea ai er reni tan n di a a i a vene en ne a a n na mn nr a a a T 33 104 fe rc a lex BioTrends User Guide Environmental Monitoring Software System To create the list of departments insert just the name The description may be alphanumeric Departments LA Departments Field Description E o O 27 01 2012 15 44 Number ofitems 0 4 Figure 34 Insert or Edit Department 4 2 2 16 Areas These are the areas which the departments are divided in Type and department are attributes of the Area The description may be alphanumeric E Departments FIG n Input of data a n 2 gt Area s Field Description ri INI 27 01 2012 15 48 E Number ofitems 0 4 Figure 35 Input or Edit Areas Nome File BioTrends 2 3 User Guide docx 34 104 fe rc a lex BioTrends User Guide Environmental Monitoring Software System 4 2 2 17 Rooms These are the room included in each area The description may be alphanumeric Departments GIE Print xport Rooms Specific Bacte
42. equal to zero the number of samplings bigger than zero but less than alert level the number of samplings greater than Alert level but less than Action level and the number of samplings greater of Alert level TETTE archilex BioTrends ver 2 3 BioTrends reports and statistic E File Tasks Analysisand Trends View Admin Windows Help E Mail x BioTrends APRIL x Und 7 L Define Report Results Graphs Create and edit Reports m 211 C1 Results equal to Values greater A Results equal to Values greater lerts no zero than zero zero than zero no Results equal to Values greater zer than zero E 212 C1 5 63 Results equalto Values greater Alta an Results equal to Values greater E ____G Results equal to Values greater Gamnlina nn Averane Print 3 Col X2 Row v 6 Info Q Lock Time 09 41 Figure 112 Reports and Statistic Histogram of Statistic The first histogram show the total results of all sampling points the others are one for each sampling point Using the Graphs toolbar is possible i Print 2 3 Col X2 Row a b a Print the Graph b Change the type and the number of graph showed The number of Histogram viewed is the same as the number of histogram printer for each A4 page Nome File BioTrends 2 3 User Guide docx 89 104 ferc a lex BioTrends User Guide Environmental Monitoring Software Sy
43. levels By filling in the list of limits in advance and giving an evident description to each limit it will not be necessary to enter the limit values for every single sampling point it will be enough to select the desired type of limit from the list pai Insert or Edit Limits Input of data Limits Description Rate Class Units Decimal digits Alert Level gt Action Level gt Data entrata in vigore 25 01 2012 11 41 15 Figure 20 Insert or Edit Acceptance levels 4 2 2 3 Type of count The type of count e g by filtration on plate is used as detailed information when entering the data related to a sampling session for finished products or for raw materials amp Insert or Edit Types of Count Input of data A Types of Count Field Description Figure 21 Insert or Edit Type of count Nome File BioTrends 2 3 User Guide docx 28 104 fe rc a lex BioTrends User Guide Environmental Monitoring Software System 4 2 2 4 Type of method This list defines the type of sampling methods for the sampling points The records identified by a padlock are system records and are locked The records are not modifiable E Types of Count Types of Method gt Status Active C Insert or Edit Types of Method Add Change _Print___Export Input of data Types of Count EZE Types of Point Classes of sampli NE Type Active Air Sampling Aria amp Settle Plate Aria amp
44. on Given that Maps are interactive it is possible view the Deviation in the Area in the selected period highlight the sampling points with result out of alarm levels and view the trend of a specific sampling point Area Dispensing gt Department Dispensing gt Map 1 2 a piano magazzino Rev 12 wmf ILE Selected point 36d 2 Box 3 vicino alla bilancia Show Personnel List Point info Air 36d N C gt 250 ufc m3 gt 500 ufc m3 Box 3 vicino alla bilancia fon Legenda Bair ns Air Settle Plate Y Air Active Air Sampling DI surfaces Surfaces Contact Plate q Surfaces Swab T Compressed Gas ZONA amp ATTESA MAGAZZINO ALTO Figure 100 Map To select a sampling point just click on the relative icon on the lay EEE out or select it in the combo box The sampling point selected is 36d 2 Box 3 vicino alla bilancia 36c 2 Box 2 superficie bilancia ni 36c 3 Box 2 parete sopra la ripresa 36d 1 Box 3 entrata 36d 1 Box 3 pavimento entrata 36d 2 Box 3 superficie bilancia 36d 2 Box 3 vicino alla bilancia 36d 3 Box 3 parete sopra la ripresa 36dA Pistola aria compressa 57 F SU ute highlighted on the map Action Level gt 500 ufc m3 Description Box 3 vicino alla bilancia Alerts no 0 It is also possible to deselect a type of sampling point The 4 ya ara Department Dispensing gt Map L 2 a piano magazzino Rev 12 wmf
45. scheduler If the reminder box is checked an alarm will be showed x Untitled Appointment 07 02 2012 07 00 00 07 02 2012 07 30 00 Reminder 15 minutes Figure 126 Scheduler Add Note window 9 1 4 Reminder A reminder window will be showed when the expiration of an item will be coming The period of notice for each type of items is settable in the BioTrends Option menu E H 2 Reminders 9 test321 TSA Start time 29 01 2012 00 00 00 2 test123456 TSA d55 F test321 TSA Click Snooze to be reminded again in 5 minutes Figure 127 Scheduler reminder window It is possible to set the snooze period Nome File BioTrends 2 3 User Guide docx 103 104 fe rc a lex Biolrends User Guide Environmental Monitoring Software System 10 E mail function Selecting the menu E Mail is possible to send an e mail message Depending on the option selected for sending e mail standard e mailing program or SMTP server clicking on the menu a new me mail message will be showed E archilex BioTrends ver 2 3 a File Tasks Analysis and Trends View Admin Windows He E Mail li Biotrends Follow Up _ High Importance e Zoom Fitz info Lock Time 60 00 Figure 128 E Mail function 10 1 SMTP Mail Server If the SMPT mail server option is selected True see Option the email window will be as the follow
46. the Results and Statistic section is possible to obtain the Graph Tab Report and statistic GRAPH from Results 7 3 3 1 key to obtain the Trends of sampling points showing the Alert Level in 3 Col X 2 Row In the Results tab click on blue the Action Level in red default color and the linear regression line i O 4 5 5 a a 3 3 x Create and edit Reports View Admin Windows Help E Mail BioTrends Define Report Results Graphs E File Tasks Analysis and Trends 205 1 0 2009 11 50 21 08 2009 00 00 10 08 2009 00 00 Total count Point Aria 311 C1 C Spogliatoio uscita centro del locale SRPS 2 Classe C O 30 092009 00 00 v 1 5109 2008 08 50 10 09 2009 07 20 07 092009 00 00 p2m0972009 10 00 28 08 2009 00 00 F 21108 2009 00 00 Ul 10 08 2009 00 00 i 930 07 2009 06 30 Total count Point Aria 211 C1 C 26 07 2009 00 00 05 10 2009 11 50 30 09 2009 00 00 25 09 2009 06 15 20 09 2009 00 00 15 09 2009 06 50 10 09 2009 07 20 07 09 2009 00 00 02 09 2009 10 00 MEDIA 28 08 2009 00 00 21 08 2009 00 00 10 08 2009 00 00 30 07 2009 06 30 Total count Point 26 07 2009 00 00 22 07 2009 00 00 17 07 2009 00 00 11 07 2009 08 40 07 07 2009 10 30 02707 2009 15 00 O 28 06 2009 00 00 8 24 06 2009 00 00 Total count Point Aria 200 C2 C Total co
47. the application In addition it will not be possible to define a new user with the same user ID Password reset Select the desired user Click on the option Change from the User Management window menu Fig 9 the window to change the selected user data will be displayed Click on the Reset password key Enter the new password Reenter the new password to confirm it Enter the reason and press save 4 2 Basic Data Input In order for BioTrends to achieve its goal it is necessary to enter all the necessary data for saving the sampling results and for analyzing such results Example In order to save a surface sampling result it will first be necessary to define in BioTrends the sampling point the production department the department area and the room within the area in which it is located its class acceptance levels etc The sampling will be performed by a person operator the result will be read by an Analyst and Approved by a manager Therefore it will be necessary to introduce in BioTrends the list of operating personnel archilex BioTrends ver2 3 File Tasks Analysisand Trends View Admin Windows Help E Mail Nome File BioTrends 2 3 User Guide docx Figure 14 Data Lists 23 104 fe rc a lex BiolTrends User Guide Environmental Monitoring Software System 4 2 1 List Window Description The Lists window shows all the data lists presents in the software including Gowning vali
48. the number of points to be included in the study it is necessary to apply filters The available filters for Reports and Investigations by Environment are the following Reports and Investigations by Environment X Filters Enwironment Add Filter Add Filter JESSE Add Filter Add Filter Add Filter a Add Filter Add Filter AEE AL Add Filter Add Filter Departments Add Filter Sampling Plans Add Filter Type of Control Add Filter pria Add Filter Add Filter x x Product Batch Results type Add Filter T Filters summary ice T Environment T T Class Select a filter from the list box and click on the T key The Y Departments item will be added in the Filter summary box CY ai Nome File BioTrends 2 3 User Guide docx 83 104 BioTrends User Guide Environmental Monitoring Software System ferchilex To manage the filter using the toolbar B H Q x Q a H Delete an Item New Filter Clear the filter summary Open a saved Filter Save the Filter Copy as New filter ae dan ea Delete the saved filter For saving a filter is required to insert a title in the Title box Define Report TT Select the time interval by means of two date controls and select the type of results Statistic of sampling results or Microorganisms identification wom 2 01 2012 10 02 2012 D i ALL to ta Statistics of samplin
49. would be possible to click on the title of the Genus column so that the comboBox is filled with all the Genus that are present on the List chose one element to obtain the list of microorganism that belong to the chosen Genus raie Bolens ve 23 BioTrends Baia lt sfoe e le Figure 18 Filter by To go back to the full list click on Refresh l Nome File BioTrends 2 3 User Guide docx i 25 104 ferchilex 4 2 2 Predefined order Data Description Units of measurement e g EU g cfu 100mL cfu g etc Acceptance levels Type of Count e g for filtration on plate etc Type of Method e g Contact Plate Swab etc Type of Point e g flat surface irregular surface etc Classes of sampling points e g A B C D ISO xxx etc Suppliers Used as attribute for batches of raw materials and for culture media batches Type of Raw Material e g Flavors Ethanol Fructose etc acceptance levels Type of Media e g BSA MCA TSA etc Type of Devices SAS Incubator etc Type of Body Point e g Gloves Footwear etc Type of Products Code Drug Name acceptance levels Type of Control e g Beginning of production during production end of production media fill etc Type of Area e g Sterile Non Sterile etc Departments Lists of Production departments Areas Company areas into which Departments are subdivided Rooms Company rooms into
50. 0 02 2012 z F Trend Deviations Details ON ZI a H 4 Reports and Statistics Alarms List Figure 101 Lay out with alarm showed Nome File BioTrends 2 3 User Guide docx 75 104 fe rc a OX BioTrends User Guide Environmental Monitoring Software System 7 2 1 Environmental Trend from a Map Select the option Analysis and Trends gt Sampling Points Map from the main menu then select one of the following option GB archilex BioTrends ver 2 3 File Tasks Analysis and Trends View Admin Windows Help E Mail Sampling Points Map Sampling Points Lists Raw Materials Finished Products Personnel Gowning Reports and Statistics Annual Report Alarms environmental samplings Figure 102 Environmental Trend from a Map menu 7 2 1 1 By Area Select Area A window with the list of the Area associated to a map is showed we aap List of areas associated with a map ws a ES ma f NON STERILE NON STERILE ACQUA 0S 1467 02 01 GE mmf STERILE MEROPENEM 2010 BASE_20100510151555 wm NON STERILE FI 410_pw_rev19 umt NON STERILE PI 420_nf _rev iG NON STERILE Fi 445 Rav 10 cewft_2008001 1202800 amf NON STERILE P 490_rev B 0enf 1 450_vaporepuro_revS mmf MEROPENEM 2010 BASE_20100610151555 wm MEROPENEM 2010 BASE_20100610151555 um MEROPENEM 2010 BASE_20100610151553 amt MEROPENEM 2010 GASE_2010061015155S umt ANH L AK MEROPENEM 2010 BASE_20100610151555 mmf MEROPENEM
51. 0 ufc m3 gt 70 ufc m3 gt 70 ufc m3 gt 30 ufc m3 gt 30 ufc m3 gt 70 ufc m3 gt 30 ufc m3 gt 70 ufc m3 gt 70 ufc m3 gt 70 ufc m3 TN fanim gt 100 ufc m3 gt 100 ufc m3 gt 100 ufc m3 gt 100 ufc m3 gt 100 ufc m3 gt 100 ufc m3 gt 100 ufc m3 gt 100 ufc m3 gt 100 ufc m3 gt 100 ufc m3 gt 100 ufc m3 gt 100 ufc m3 gt 50 ufc m3 gt 50 ufc m3 gt 100 ufc m3 gt 50 ufc m3 gt 100 ufc m3 gt 100 ufc m3 gt 100 ufc m3 INN sballo Statistics of samplin Pa 2 08 2009 E o7 09 2009 Select the necessary elements and click on i display the requested results in different reports elected Nome File BioTrends 2 3 User Guide docx Number of items 47 ways according to the type of BioTrends User Guide Environmental Monitoring Software System ferchilex 7 3 2 Report and statistic Sampling results statistics The Report and Statistic gt Statistic of sampling result tab is divided in two main parts Des Al centro del locale Al centro del locale Al centro del locale Al centro del locale Al centro del locale Vicino tavolo materiali Loc vials decont tra la Spogliatoio sotto flusso Locale Spare Parts dav Davanti alla porta di en Davanti alla porta del In mezzo alle due due Davanti alle porte dei Davanti alla porta di en Corridoio tra due porte In fondo al c
52. 03 09 2009 04 09 2009 A 04 09 2009 05 09 2009 III III lt m Statistics Values Frequency Print A 3 ColX2 Row v fom 24 08 2009 M 07 09 2009 v statistics of sampling results AE Data export T gt Ean info Lock Time 09 57 m b Show the Suggested new Alert based on one of the listed formulas 2 std dev media Results Statistics from 24 08 2009 r Total Statistics Count by Date Point 3 std dev media Lino awpoms soani 20201 30103 6 std dev media Sampling no 110 2 2 2 2 Average 11 54 28 4 6 2 Dev standard 18 306102 22 627417 0 8 485281 2 828427 Max value 123 44 4 12 4 Min value 0 12 4 0 0 Results equal to zero 35 0 0 1 1 Results equal to zero 31 82 0 0 50 50 Values greater than zero 74 2 2 1 1 Values greater than zero 67 27 100 100 50 50 Alert Level gt 70 ufc m3 gt 70 ufc m3 gt 70 ufc m3 gt 70 ufc m3 gt 70 ufc m3 Alerts no 0 0 0 0 0 Alert 0 0 0 0 0 Action Level gt 100 ufc m3 gt 100 ufc m3 gt 100 ufc m3 gt 100 ufc m3 gt 100 ufc m3 Actions no 1 0 0 0 0 a lele elmel lei o o o o Alert suggested 3 std dev me 66 458306 oS S Microorganisms amp 3 std dev media v Values Frequency Print tom 24 08 2009 v SA 07 09 2009 v Statistics of sampling results dA El Data export bd Nome File BioTrends 2 3 User Guide docx 86 104 ferc
53. 07 to 05 01 2008 Type of Control N A Alert Level Action Level 3 gt Ni pa 3 paia ha Seed 07 a ieee Uta ord ila la pe q gt a Om war 08 05 2007 kan R CELE a P Q 19 11 2007 de 5A IC as L 04 12 2007 17 i T aini fa non eg 23 04 2007 g 23 05 2007 22 06 2007 07 07 2007 22 07 2007 06 08 2007 21 08 2007 19 05 09 2007 05 10 2007 20 10 2007 47242 9 04 11 2007 19 12 2007 03 01 2008 Total Count 201 C1 Batteri 201 C1 Fungi and Yeast 201 C1 Date Value Deviations 22 03 2007 5 23 03 2007 115 2007 26 03 2007 27 03 2007 28 03 2007 29 03 2007 30 03 2007 DADOSO 0 000000 Figure 99 Exported Graph Different types of approaches are possible for environmental trends related to the air surfaces water and compressed air sampling points It is possible by deselecting a type of control view some or all sample in the period Inizio produzione lesse A Class A Port 31448 D1 2008 ts 10 02 2008 Type of Contro Inao produnone Fine produzone Mecs fil Attut Fine produzione Media fill Attivit di SETUP Nome File BioTrends 2 3 User Guide docx 73 104 ferc a lex BioTrends User Guide Environmental Monitoring Software System 7 2 Map general functions Thanks to the Map function it is possible to display the layout of a specific Area with the sampling points showed
54. 166 tejden gt e 1000 cs Rhee gt e 100 ey Themed gt 300 hey Tee gt e 100 Mel 202 100 zsm gt e 200 ufc 250m2 gt 100 ufe 2Scm2 gt e 200 fim gt e 100 Sethe gt e 100 fedima gt gt 100 aiioa gt 160 Sef Themed gt e 100 uama 200 Sel TS gt e 25 uoo gt 25 uS gt e 25 uao gt gt 25 ua isara gt 25 uia ihona e 39 demone gt e he Tere gt 200 uor gt e 300 uao gt e 200 aior gt gt 200 uta ifema gt e 2000 azor gt e 330 dy mera ze 339 Amora gt 300 uao gt 300 uor Duoerare Daserarg Cacmrers Capea um Gresser 3 purar Gresser 3 Morerd Gresser 3 Porerd Gregan 1 Piorurd Greeven 1 Prorurt Grensen 1 Morerd Grenier 1 Qorurd Groesen Oorurt Granate Morert Gresser Gorurt gt gt 200 unor G gt e 330 Amor gt e 330 dymor 20 239 heen z 339 deters Grosser 3 Orari Grener 3 Pirani 77 104 ferchilex BioTrends User Guide Environmental Monitoring Software System 7 2 2 Environmental Trend from a List Select the option Analysis and Trends gt Sampling Points List from the main menu then select one of the following option 7 2 2 1 By Environment Select the Environment desired archilex BioTrends ver 2 3 File Tasks Analysis and Trends View Admin Windows Help E Mail fis Sampling Points Map ag archilex BioTrends ver 2 3 Figure 104 Environmental Trend from a List menu Sampling Poin
55. 2 06 02 2009 16 40 04 2009 01 28 08 00 00 3 ufc 250m2 5 ufe 25cm2 09 02 2009 14 23 22 Linea 2 Classe A 2009 01 27 07 15 00 1 ufc m3 2 ufe m3 06 02 2009 16 26 02 SRPS 2 Classe C 2009 01 27 06 40 00 30 ufc m3 50 ufc m3 06 02 2009 13 47 47 2009 01 27 00 00 00 3 ufc 250m2 5 ufo 25cm2 06 02 2009 14 26 55 2009 01 22 17 10 00 1 ufe guanto 1 ufe guanto 09 02 2009 13 18 18 SRPS 1 Classe C 2009 01 20 10 30 00 30 ufc m3 50 ufe m3 26 01 2009 14 56 41 SRPS 1 Classe C 2009 01 20 10 15 00 15 ufc 25cm2 25 ufc 2Scm2 2009 01 20 09 35 00 3 ufc 250m2 5 ufc 25cm2 Linea 2 Classe A 2009 01 20 08 49 00 1 ufo m3 2 ufe m3 Linea 2 Classe A 2009 01 19 20 01 00 1 ufo m3 2 ufe m3 2009 01 16 15 40 00 1 ufc guanto 1 ufc guanto 2009 01 16 11 55 00 1 ufc guanto 1 ufc guanto 2009 01 15 21 30 00 3 ufc 250m2 5 ufe 25cm2 314 A17 Lines 2 Classe A 2009 01 14 20 05 00 1 ufc m3 2 ufe m3 pad w weu ean Sgun RSH uw vw dd o a ee ee ee 28 01 2009 11 37 08 27 01 2009 10 11 59 06 02 2009 16 33 09 06 02 2009 16 02 26 22 01 2009 11 02 01 22 01 2009 11 01 16 22 01 2009 10 05 53 21 01 2009 10 23 15 22 13 02 2012 08 48 T Number of tems 37 Figure 117 Alarm Environmental Samplings List The opened window shows the list of sampling point with a result greater than acceptance levels The default period is the last month It is possible to filter the result by just Action or just Alert By double click on a sampling point the relative sampling session is showed Nome File Bi
56. 2010 11 25 fuori limite E 2A10K25 1 E SRPS1 2 E Superfici E 114 D1 2010 11 25 fuori limite Classe D E 300A D2 2010 11 25 fuori limite E 2A10K26 E SRPS1 2 E Aria E 204A D6 2010 11 26 fuori limite E SRPS 2 Classe C E Superfici E 305 C1 2010 11 26 fuori limite Number Opening Date Closing Date Note Status Batch number Area Type Point no Date of control Note Genus Species L Result t E 216 2010 2010 12 10 fuori limite aria OPEN E 2A10L01 E Linea 2 Classe A E Aria E 314 A1 2010 12 01 fuori limite Number Opening Date Closing Date Note zone Batch number Area Type Point no Date of control Note E 22 2011 2011 01 27 fuori limite aria El 1A11A19 E SRPS 1 Classe C E Aria E 203 D1 2011 01 19 fuori limite 00 00 00 classe A E 1A11A19 1 E SRPS 1 Classe C Aria E 203 D1 2011 01 19 fuori limite Staphylococcus none Genus Speci L Result t Number Opening Date Closing Date Note Tone Batch number Area Type Point no Date of control Note Genus Species l esult E 221 2010 2011 01 14 fuori limite E Linea 1 Classe A E Superfici E 217A119 2010 12 07 fuori limite 00 00 00 sup classe A E 217A129 2010 12 09 fuori limite a i LESS O o n lars ra n la IS ln 0 le e p les lt P 10 02 2012 12 43 Figure 94 List of Deviation report window a Environment b Personnel c Raw materials d Finished products Nome File BioTrends 2 3 User Guide docx Staphylococcus haemolyticus Staphylococcus hominis i Number of items 24
57. 3 Gowning Validation acciai 64 0 3 1 Starting a new Gowning Validation CYyCle iii 64 5 3 2 Closing a Gowning Validation CYCle iii 65 5 3 3 GowNnng Valdation Listessi neea EERE EN N NEEESE ERTA EEO NEEE inni 66 5 4 Deviation Report sssesseseesossescssesscseescssescssescosesccsessossescssescosessoseescesercssesccseecoseescssesccsesecseseossesccsesccseseoseescssesceseeeessee 67 5 4 1 CHEATING a deviation Tenor preoa E E O TO E E TE erste 67 5 4 2 LISFOFDEVIGIOA REport acse aio 68 6 VIEW HISTORICAL DATA USING THE SAMPLING SESSION PAGE sssssssssssussnnnnnsnnnnrnnnnrnnnnns 70 7 ANALYSIS AND TRENDS OF DATA ccccsssssssessesssessescesseeseesseessessesseeseeseeseeseesseesoesesessessesseeseesesens 71 TA Trend GEMM al MUMCE ONS irisaren rn rai RI i rire si 71 TZ Mapigeneral TUNCLONS ssssixtacesrsvisaivervuonterewssunensbennmeneniesivnebenudehuvesstunrsinnboueveunbehaheayhebavonsdeuseuutviubenabenvisetubeenbenes caus 74 7 2 1 Environmental Trend from a Map iii 76 fer as BYA ee ee E E Po re ee eee eee ee renee 76 2 12 BENINO laica 77 tizio BIEN nari 77 1 2 2 Environmental Trend from a LISt iii 78 2 2 By ENVINOMPIUCING scccectssseacaseces acyauny snes E ae 78 Nome File BioTrends 2 3 User Guide docx 7 104 Felc N lex BioTrends User Guide Environmental Monitoring Software System 222 BYDE 1 aan 79 7 2 3 Raw Materials Feanor 80 1 2 4 FIDISNE
58. 4 Choose from the Filter list in order to have the possibility of displaying the following deviation reports 68 104 fe rc a lex BioTrends User Guide Environmental Monitoring Software System To add a new deviation report in the system click on the option Add from the window menu See Creating a Deviation Report To modify the general information about a deviation report select the box corresponding to its number and click on the option Change from the window menu the screen to modify data will be displayed Input of data Deviation reports nl Opening Date 11 11 2011 11 11 2011 Closing Date 11 11 2012 11 11 2012 Description test test Signature of Res Calda Andrea Calda Andrea Status OPEN OPEN Figure 95 Edit Deviation Report Change the desired fields enter the reason for the changes and click on the Save key To display the Sampling Session page related to the sampling operations mentioned in the report double click on the Control date box corresponding to the desired sampling Nome File BioTrends 2 3 User Guide docx 69 104 fe rc a lex BioTrends User Guide Environmental Monitoring Software System 6 View historical Data using the Sampling Session page To open the list of Sampling Session for viewing historical data click on View gt Sampling Session in the Main menu g archilex BioTrends ver 2 3 File Tasks Analysis and Trends BioT re e PIV Figure 96 View men
59. 9 1 1 SCAEUUIer TOOD iii 99 9 1 2 Sched ler Calendar Navigation ct eroi 101 9 1 3 Scheduler Functionality MENU i 102 9 1 3 1 Add Sampling SCNEAUEC c na 102 FES GOT FOY earn ee ee A OE OANE A OES 102 tl GOO OTE e A I E E A E 102 Hi E WN T O eaa A E E E eee E E ee eee 103 Tar AGNO 103 9 1 4 EEE AE E EEE TE E EA E EAE E E E AAEE E A A E E E EAE T 103 10 E MAILFUNCIION iii 104 10 1 SMEP Mal Severa iaia 104 Nome File BioTrends 2 3 User Guide docx 8 104 ferchilex List of Figure Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Figure 6 Figure 7 Figure 8 Figure 9 Figure 10 Figure 11 Figure 12 Figure 13 Figure 14 Figure 15 Figure 16 Figure 17 Figure 18 Figure 19 Figure 20 Figure 21 Figure 22 Figure 23 Figure 24 Figure 25 Figure 26 Figure 27 Figure 28 Figure 29 Figure 30 Figure 31 Figure 32 Figure 33 Figure 34 Figure 35 Figure 36 PRIMARIE 11 BIO MOOS 1601 catania nana 12 Log IMTWINCO RN snai rada 12 Success Log IN WING Writer i 12 Changing Password WiINdOW iii 13 FIOR 14 Main WINGOW RR TA 15 Quick Access WINDOW arno 15 127 GWE 904001 penne aren amen e RR SEO 16 Quick access Toolbar 18 Main window with quick selection 19 User Management WINdoW iii 21 User Data INPUEWINAOW snirria nici 22 Data lisina annie 23 L IN 24 Insert or Edit WINDOW irniliiriirnia 24 Exporti
60. Contact Plate Superfi A Swab Superfi a Filtration Acqua Types of Method Field Description Type Type of Environment Status 2 27 01 2012 12 23 G Number ofitems 5 7 Figure 22 Insert or Edit Types of Method 4 2 2 5 Types of Point This attribute is related to the Surface sampling points This parameter can be used to differentiate the surfaces like floor wall ceiling or irregular flat E Types of Count Types of Point gt Filter Cilkar racultc ani jyji0iua Insert or Edit Types of Point Add Change Print Export Types of Count Types of Meth Types of Point Classes of sampling In put of data Type gt Types of Point 9 27 01 2012 12 32 Number ofitems 0 4 Figure 23 Insert or Edit Type of Point Nome File BioTrends 2 3 User Guide docx 29 104 fe rc a lex BioTrends User Guide Environmental Monitoring Software System 4 2 2 6 Classes of sampling points They constitute one of the Sampling point attributes When a sampling point is added to the database the class to which such point belongs must be specified choosing the correct value of the attribute from the predefined list of Classes connected to sampling points i Insert or Edit Classes of sampling points Cet Input of data Classes of sampling points Field Description value Z Figure 24 Insert or Edit Class of sampling points 4 2 2 7 Sup
61. Gd PEOGUCIS LISNO Sii 80 7 2 5 Personnel Gowning Fedra 81 7 3 Reports and Statistics general functions ssssssssssesessssseeccosssssssssssesssseeccocsssssssssesesssseeecoccssssssssseessseeeeeeeseese 82 7 3 1 Report and Statistics Define a Report iii 83 1 3 2 Report and statistic Sampling results statiStiCS i 85 7 2 1 Result Tab eaU siae 85 7 3 2 2 Statistics Tab Features ii 86 7 3 3 Report and statistic GRAPH of sampling results statiStiCS i 88 1 3 3 1 GRAPAIFOMIRESUNS earn 88 RAZOR e I EI 89 0 0 0 GRAPH from Vales FFEQUENcyY scraac an 90 1 3 4 Report for Sampling results statistics uii 91 1 3 Reports and Statistics Microorganism Identification statistics i 92 7 3 5 1 GRAPH from Statistic of Microorganisms investigation 93 LA ANNUALreport arianna 94 7 5 Alarms Environmental Samplings sssccccssssseccccssssscccccssssecccccsseeccccessseeccccenseeccccesseeeecenasseeccecaseesessuesseees 95 8 BARCODEMOPBULE ia 96 8 1 New Labels Print template nooeesoseesoesesoosesscssescssesccssesccseseoseescssesccseseoseeeossescesesccsescosessossesccsescoseseossescssesesseseesese 97 9 SCHEDULERMODBDULE ici 98 91 Scheduler RO AUG iii cis resine iaia ccctuaseusananucnassnaciwaisnceconctuadeacaususanassuncenstsactcoesseessunsareteaasinas 99
62. Gowning Validation Cycle ui 64 Figure 87 Gowning Validation Test Number bOX essssssesssssssesesssssesessessee 65 Figure 88A B C D Closing a Gowning Validation Cycle 65 Figure 89A B Gowning validation ii 66 Figure 90 Insert or Edit Gowning Validation Expiring Date 66 Figure 91 New Deviation Report 67 Figure 92 Insert New Deviation Report Window 67 Figure 93 Opening List Deviation ReportS 68 Figure 94 List of Deviation report WINdOW esssssssssssssssseseeeeeeereeeeeeeeseeeee 68 Figure 95 Edit Deviation Report ela 69 Figure 96 VIEW MENU eroe 70 Figure 97 Analysis and trends MENU 71 Figure 98 Trend cca 71 Figure 99 Exported GE aria 73 Fig r 100 M pagane raro 74 Figure 101 Figure 102 Figure 103 Environmental Trend from a Map MeNnu sssseceeeeeeeees 76 List of Area associated to a Map 76 Figure 104 Environmental Trend from a List MENU 78 Figure 105 Figure 106 Figure 107 Figure 108 Figure 109 Raw material TPG dna 80 FinishedPro duelli 80 Personnel Gowning Trend iii 81 Reports and Trends WINdoW ii 82 Statistic of Sampling result WINdOW L 85 Figure 110 Report and statistic Statistic Of result 86 Felc N lex BioTrends User Guide Environmental Monitoring Software System
63. Login attempts Figure 13 User Data Input window Fill in all the fields present in the window and click on the option Save the new user will appear on the list The password minimum pre set length can be configured The minimum admissible value is 4 and the maximum one is 20 See Options management To Cancel the operation click on Close without saving first Changing user s properties Select the desired user Click on the option Change from the User Management window menu Fig 9 the window to change the selected user data will be displayed Change the desired fields and click on the option Save To Cancel the operation click on Close without saving first x Nome File BioTrends 2 3 User Guide docx 22 104 ferchilex 4 1 4 1 2 4 1 5 1 2 4 1 6 BiolTrends User Guide Environmental Monitoring Software System Disabling a user Select the desired user Click on the option Disable from the User Management window menu Fig 9 the user will be disabled and will no longer be able to access the application Enabling a user Select the desired user Click on the option Enable from the User Management window menu Fig 9 the user will be reinstated and will be able to access the application again Deleting a user Select the desired user Click on the option Delete from the User Management window menu Fig 9 the user will be deleted and will no longer be able to access
64. Options to be modified and the desired element click on the Edit key next to it and enter or select the value Click on the Apply key to save the new value and continue Click on OK to save the new value and close the window Nome File BioTrends 2 3 User Guide docx 49 104 ferchilex 4 6 1 Colors of Acceptance levels BiolTrends User Guide Environmental Monitoring Software System lt can be used to set the display colors of the sampling values that exceed the limits set by the acceptance criteria as well as the colors of the lines that will indicate such values on graphs It is also possible enable a message showed when the value inputted is greater than acceptance levels Sa Options amp Automatic Log Off Customizable Fields Description W Files Folders Application g7 Signatures reasons Options F PDA Colors of acceptance levels E Data Input Expiring periods LI Colors of acceptance levels Color Value Basic colors Alert Level 16711680 iT Ml Sew Action Level 255 Values greater than zero 65280 a x E E A E g m Show a message the value exceeds the acceptanc True fissi El E E hai A E a BREE EEE BEEBE EEE amp BEEBE Custom colors FREE ea Define Custom Colors del Allow to setthe displayed colors in the sampling values which exceeumga ka Ok 3 Hue 160 Red 0 Sat 240 Green 0 ColoriSolid Lum 120 Blue 255
65. Products Trends Select the option Analysis and Trends gt Finished Product from the main menu archilex BioTrends ver 2 3 i Sampling Points Map Sampling Points Lists Raw Materials Finished Products Personnel Gowning Reports and Statistics Annual Report Alarms environmental samplings In the list of Finished Product showed select one same me define the period and click on Trends The Trend Duvium 1000 30 bet Fluimucil JR 100 MG 20 cpre A x a Fluimucil JR 1000 MG 20 cpre of the Selected Raw Material will be displayed Saas Fluimucil 100 20 cpre Fluimucil 100 SOcpre Fluimucil 100 100cpre Fluimucil JR 100 MG 50 cpre Fluimucil 18cpre 200mg Fluimucil 200 20cpre Fluimucil 200 Bruis 20cpre Fluimucil 200MG 20cpre Fluimucil Akut 200MG 20cpre Fluicil 20cpre 200mg Fluicil 20cpre 200mg Lysomucil 200 30cpre Fluimucil 30 cpre 200 MG Exomuc 30cpre 200MG Exomuc 30cpre 200 MG Fluimucil 200 20 cpre Nome File BioTrends 2 3 User Guide docx BioTrends User Guide Environmental Monitoring Software System 2a i 001 20 0 02 2012 I dl geni 11 01 2012 M 10 02 2012 gt INR 80 104 ferchilex 7 2 5 Personnel Gowning Trend Select the option Analysis and Trends gt Personnel Gowning from the main menu Select the period desired the name of the Person which type of sampling plan use and click on Trends The Trend of the selected person for the specific sampling plan will b
66. To make any changes You must request modified See Signature Undo request section to apply the procedure undo of close approval signatures Do you want to do it now Biotrends Ver 2 3 0001 When the sampling session has been unlocked click on the specific field and change the information or the incorrect data Confirm or not the change in the message box And if the change has been confirmed input an explanation for the change Motivation of data change To save the change write the motivation and press Ok Figure 82A B C Changing datum Nome File BioTrends 2 3 User Guide docx 61 104 ferc a lex BioTrends User Guide Environmental Monitoring Software System 5 2 Signature Undo Request When a sampling session has been signed it can only be modified if an undo request is previously sent to signatories and they actually undo their signatures Biotrends Ver 2 3 0001 To Start the Signature Undo request procedure the User may click on Yes in Analysis session is closed To make any changes You must request the message box showed when tried to modify a datum in a closed or undo of close approval signatures Do you want to do it now approved sampling session jw Signature reason Jate Closina Samplina session 07 02 2012 11 33 25 Or click on the specific key showed in a closed or approved sampling session Approval Sampling session Date E under the signature fields
67. a lex BioTrends User Guide Environmental Monitoring Software System c Display the Frequency of the Value result Results i Statistics Results frequency SAMPLINGS 110 2 2 2 2 2 74 2 1 1 2 2 5 0 35 2 0 1 1 2 2 1 1 0 1 1 3 1 2 0 0 0 0 0 0 0 0 0 0 0 1 2 7 0 0 o 0 0 0 0 0 0 0 0 0 3 4 0 0 0 0 0 0 0 0 0 0 0 0 E 4 11 0 1 0 0 0 0 0 0 0 1 1 0 5 2 0 0 0 0 0 0 0 0 0 0 0 0 6 2 0 0 0 0 0 0 0 0 0 0 0 0 2 0 0 0 0 0 0 0 0 0 0 0 0 LA 8 6 0 0 0 0 0 0 0 0 1 0 0 0 9 2 0 0 0 0 0 0 0 0 0 0 0 0 10 1 0 0 0 0 0 0 0 0 0 0 0 0 12 7 0 0 1 0 0 0 0 0 0 0 0 0 13 1 0 0 0 0 0 0 0 0 0 0 0 0 16 1 0 0 0 0 0 0 1 0 0 0 0 0 17 1 0 0 0 0 0 0 0 0 0 0 0 0 19 1 0 0 0 0 0 0 0 0 0 0 0 o E an e n n n 1 n n n n n n n n lt tn Statistics Microorganisms Prit A 1ColX1Row r _R SSS ROTTO ces 0 Info Q Lock Time 09 07 J 4 d Printthe showed statistical results e Display the Histogram of the Statistic result It is possible to select the lay out of the view Columns 3D Clustered Pies 3D Pies 3D Exploded Columns Clustered Pies Pies Exploded 1 Col X1 Row 2 Col X1 Row 3 Col X1 Row 2 Col X 2 Row 3 Col X 2 Row 4 Col X 2 Row 3 Col X 3 Row 4 Col X 3 Row 3 Col X 2 Row Nome File BioTrends 2 3 User Guide docx 87 104 BioTrends User Guide Environmental Monitoring Software System ferchilex 7 3 3 GRAPH of sampling results statistics From
68. a al 5 k lt Plant de a Da i Department RO Department x i od x E aos ee i DI io ira nnt a D aa CE I ni n i i ee Ce re ne pare aA 14 a TESTE Ul te sia Rea cd si I l F i i a p i Area Sterile Room R Area non Sterile l Room ti i i p7 n ne i i i p See ek ee l i i LE fT i E M i i it 5a Point i l MO Room i Samp point NL TI Room LI mp 1 if I i E 5a I i x i i I i mp Point Tn 1 i SE ore Samp point pa Samp Point iniiai 1 li Samp Pont LI on I i Room n 1 ts I x i Fe ot Samp Point il 1 gd i i U T m ee ee F I I i i I i I i De B o CONO GU CHI N AE A I N N ee se ee A ee ee ee Si ee ee i a M _ i I I i Samp Point i i l A ea IA I a Samp Point Ji i i O za Sin aii yl i i 5 rile a e e ia 7 i i gt Claas oases I i a Area i ri Li 4 I I SG 2S S 2S SSS SSE SSSESSSESSBESE SESE SESE SE SS FS I P non ster Room id 1g a a ee ete ee ete eee i rl i id ij y SSS I a 7 I ti Area Sterile hs i i E R 4 1 Samp Pont ii ij F Room a I oom il ei ii i l ii Di DI samp Point Tae 4 atest ii i 14 Samp Point bi ng i I Samp Point dI i i 4 Samp Pont i oa Ii ony i Room T calata i i i il Samp Point ih 2 Pa yt cf i l 7 i Point i I 4 Samp Point i af tot i i i samp Point da Uda i ow E ee cee N t i an Samp Point HI at i EE E AORERE F f j i a ty O r ai li i L A
69. ading result of specific bacteria analysis Analysis Approval signature 1 Analysis Approval signature 2 Opening deviation report Closing deviation report Signature Undo Allows to specify the reason ofthe signatures bioMaintainer Opening of a sampling session Sampling Sampling End Incubation 1 Incubation 2 Incubation 3 Read Result of sampling Read Result of LAL Read Result of identifications Reading result of specific bacteria analysis Closing Sampling session Approval Sampling session Opening deviation report Closing deviation report Signature Undo el Ok Cancel Apply Figure 70 Options window signature Reasons Nome File BioTrends 2 3 User Guide docx 51 104 ferchilex 4 6 5 Automatic Log Off BioTrends User Guide Environmental Monitoring Software System It can be used to set the inactivity time that has to lapse before the software automatic Log Off due to safety reasons See Automatic Log Off Colors of acceptance levels E Data Input Automatic Log Of Customizable Fields Description Options Expiring periods Signatures reasons I FilesFolders Application fi PDA Automatic Log Off Automatic Log Off time in case of no Activity Sec User s Log Off checking time out mSec outto check the user s logon Allows to set the idle time length no activity reported before an automatic Log Off is performed
70. cated in the menu on each specific window and select the folder in which the HTML file will be saved HE Desktop Organizza v Nuova cartella Sk Preferiti Raccolte BE Desktop artella di d Download D Ris ent 4 Compu artel Ga Raccolte en PRESENTAZIONI fee Immagini P Musica E video 18 Computer amp Disco locale C cy RECOVERY D Ge Dar Nome file IMERESE ICR Salva come html Files Nascondi cartelle Figure 17 Exporting a list Once the export has been completed the File will be displayed in the predefined Browser The html File is formatted in tables and can be displayed and or imported in all the software applications that can display and manage Html files e g MS Word MS Excel etc 4 2 1 5 Filtering contents In the Lists window there are two types of filters e Primary Filter which is available only for certain types of lists choose an element from the corresponding ComboBox to obtain a coherent list with the selected filter e Universal Filter Filter results by which can be used in any type of List To load data in the Filter results by Click on the title of the attribute column columns of the list corresponding to the filter to be applied thus the comboBox will be filled with all the elements of that column that are present on the list select one of those elements to obtain the list filtered according to the chosen criterion For example for Microorganism it
71. ccccssssecccccsssecccccsseeccccassseeecoussseesceeaseeseesaseeessoss 49 4 6 1 Colors of Acceptance levels eee eee eee ee eee eee ee 50 4 6 2 Bie ic alg 6 0 arene E ee er ene eee eee ee eee ee ee ee ee eee 50 Nome File BioTrends 2 3 User Guide docx 6 104 Felc N lex BioTrends User Guide Environmental Monitoring Software System 4 6 3 EX Poio0iS a aa 51 4 6 4 Sonare CIS 51 LOS AUM U LO O e E ta 52 4 6 6 CG stomizable feld CSS CTO GIN cn 52 4 6 7 FISSO er A E A E E E A E E EE E EAE E E N E E 53 FAGAN a aE EEA A A E EE A A EE A EAEE EA 53 4 6 9 PP POE A E A E EA E E E E A A E E A T E EE 54 SS rts nee acs eevee taser o 55 Sl SRP 56 5 1 1 Creating a new Sampling session iii 56 olii From Me Menu 56 old Froni CMO OOM a AEEA EAA E E AER 57 5 1 2 List of Sampling sessions in progress and or completed 58 ll FONICO ere tiri 58 5 1 2 2 View Sampling sessions in progress and or completed from the scheduler 59 5 1 3 SAMPING PONS and alessia 59 5 1 4 Closing a Sampling SESSION iii 60 5 1 5 Changing a sampling session data iii 60 5 1 5 1 Changing data in a Sampling session IN ProgreSss iii 60 5 1 5 2 Changing data in a Sampling session Closed or Closed and Approved i 61 5 2 Signature Undo REQGUES assassine TT 62 5 2 1 Signature Undo IRCQUESIS LIST 63 5
72. ch number all the information must be filled No empty field is accepted 4 2 2 28 Finished Product Batches This is the list of Product Batches number Insert or Edit Products batch Cel Input of data Products batch Field Description Value o Batch number Product Quantity Order no Figure 51 Insert or Edit Product Batch To save a new batch number all the information must be filled No empty field is accepted 4 2 2 29 Culture media batch This is the list of Culture media batch used for the environmental activity Insert or Edit Culture media batch 83 Input of data gt Culture media batch Field Description vale I Batch number Type Supplier Expiring date Quantity Status Figure 52 Insert or Edit Culture media batch To save a new batch number all the information must be filled No empty field is accepted Nome File BioTrends 2 3 User Guide docx 41 104 fe rc a lex BiolTrends User Guide Environmental Monitoring Software System 4 2 2 30 Sampling Plans Sampling data are collected in a structured way by means of the sampling plans defined by bioAdmin and or bioSupervisor users see User Management which will contain homogenous elements sorted into groups according to the type of Control Air Surfaces Personnel etc After defining all its elements such as Type production department the relevant area within the department title the points to be sampled
73. ctive waiting for responsible signature es oe c Active at least one signature ese d All active in progress canceled RES e Canceled w 28 02 2013 12 02 29 28 02 2011 11 33 45 20 02 2013 12 0719 Camponamento aperstori eseguo da LS LINEA 2 05 0 rode oz Gi n 2021 13045100 ren 2a 02 2011 1210491 Autocampunamento spersten LIMBA 1 05 009 roe 2021 13 3 ra 28 02 2013 11 96 00 Linea 2 SUPERFICI FINE PRODUZIONE pos Dls 5 13 90 24 02 2013 10 33 31 Lee DOGATRICE IMA CONTROLLO COMPLETO oS Porm G z 0 SUPERFICI FINE PRODUZIONE Lines 1 DOSATRICE ZANASI FINE CAMPAGNA MR ALtocarmponamento cpersisn LINGA 3 Important The sampling data entered in a sampling S ce _ ET session that has not been declared to be complete will not be displayed in the trends See Closing a sampling session Nome File BioTrends 2 3 User Guide docx 58 104 fe rc a lex BioTrends User Guide Environmental Monitoring Software System 5 1 2 2 View Sampling sessions in progress and or completed from the scheduler See Scheduler chapter 5 1 3 Sampling points and plates This list and its filters enable operators to know the sampling operations they have been assigned analysts to know when to read plates and managers to control the progress of activities archilex BioTrends ver 2 3 File Analysis and Trends View Admin Windows Help E Mail 1 To open the list click on the option Tasks gt Samplings g
74. ctivity using the scheduler interface if installed To do so the laboratory manager or a User with an appropriate security level should create new work sessions from existing models Sampling plans set the date and time of sampling starts assign the sampling activity to an operator and if necessary fill in the screen with all the information he she has such as the batches that will be in production while sampling is being performed whether the controls will take place at the beginning of production during production or at the end of production etc 5 1 1 Creating a new Sampling session To open a new sampling session follows one of the forward methods 5 1 1 1 From the Menu 68 archilex BioTrends ver 2 3 1 Click on the option Tasks gt New gt Sampling session from the main menu in order to have access to the lists of sampling plans j Sampling session Samplings Li i Deviation report Ga Gowning validation amp List Deviation reports 2 Click on the icon in the quick access toolbar lick N i h dl TES m l a Updated 13 01 2012 11 56 56 Z Refresh 4 New Sampling session i Samplings Number 3 Click on New Sampling Session in the Quic ETa h San n p Samplings amp Media 2011 330 access window Sampling sessions amp Exceeding Acceptance Limits I Signatures undo requests Alert last thirty days 7 H Trends Action last thirty days 3 I Sampling Points
75. d to manage environmental monitoring without using paper With a state of the art solution we can support the barcode technology to track all the activity in your monitoring programs Samplings incubations readings and identifications are totally in your hands Responsible Create new Samples Sessions Assign Tasks Activate Tasks Operators Analysts Tasks List Sampling media incubation results reading di di Results reading Sampling media incubation Approval Figure 1 Planning and Entry Nome File BioTrends 2 3 User Guide docx 11 104 fe rc N OX BioTrends User Guide Environmental Monitoring Software System 2 Starting the software To Open BioTrends located the following icon on the desktop and double click on it Figure 2 BioTrends Icon 2 1 Access to Software When the software is started users must identify themselves by entering their name and password see figure 3 The program verifies the data that have been entered and if they are correct checks that the same user is not already connected from another computer In case of finding another session with the same user it is possible either to abandon or to disable the other session If it is disabled the other session will no longer have access to the database The system is supplied with a predefined user with administrator privileges user ID biotrendsadmin password biotrendsadmin Access the software with th
76. dations deviation reports alarms The main functions of this window are Filtering contents adding and changing elements printing exporting data CI Departments E Departments e 2 Print Rooms Name 2 24 01 2012 12 47 E Numberofitems 0 Z Figure 15 List window 4 2 1 1 Adding a new element to the list To input a new parameter click on the Add option located in the menu on each specific window An insert window is displayed Pa Insert or Edit Air 8 Input of data Air Number Room Class Area Description Standard vol Exposu Limits Department Method Figure 16 Insert or Edit window 4 2 1 2 Changing theattributes of an element To edit a record select an element from the list and click on Change option located in the menu on each specific window to display the screen for changing the attributes of the selected element To save the change an explanation in the Notes field must be inputted Some attributes of specific record cannot be modified 4 2 1 3 Printing alist To print the list of records click on Print option located in the menu on each specific window Nome File BioTrends 2 3 User Guide docx 24 104 fe rc a OX BioTrends User Guide Environmental Monitoring Software System 4 2 1 4 Exporting a list It is possible to export and save the list of records in a file with extension html To perform the export click on Export option lo
77. e authentication has been completed a user wants to change the password proceed as follows Li Enter user Name 2 Enter Password 3 Click on the log in key if the data have been correctly entered the change password and the Enter key will be shown 4 Click on the change password key see Nome File BioTrends 2 3 User Guide docx 13 104 fe rc a OX BioTrends User Guide Environmental Monitoring Software System Expired Password 2 2 LogOutfrom the Software To log off voluntarily from the software the User may select the option File gt Logout from the menu _ te archilex BioTrends ver 2 3 z File Tasks Analysis and Trends View Admin Windows Help E Mail Figure 6 File option 2 2 1 Automatic If the user does not perform any operation for x minutes see Configurable parameters BioTrends for safety reasons will disconnect the user who will be able to continue using the program only after having entered the corresponding user ID and password again see User registration 2 2 2 Ending the work session To end the BioTrends work session select the option File gt Exit from the menu Fig 6 Nome File BioTrends 2 3 User Guide docx 14 104 fe rc a lex BiolTrends User Guide Environmental Monitoring Software System 3 Main window After the Log in has been done successfully the software display the main window File Tasks Analysisand Trends View Admin Windows He
78. e displayed Nome File BioTrends 2 3 User Guide docx g archilex BioTrends ver 2 3 Analysis and Trends E Sampling Points Map Sampling Points Lists Alarms environmental samplings View Admin Windows Help E M a Figure 107 Personnel Gowning Trend BioTrends User Guide Environmental Monitoring Software System Gowning sampling amp Colombo Giorgio amp Corrado Raffaele amp Fadda Patrizia a Autocampionamento operatori LINEA 1 Autocampionamento operatori LINEA 2 Controllo indumenti Linea 1 Controllo indumenti Linea 2 Controllo indumenti personale LINEA 1 Controllo indumenti personale LINEA 2 Convalida di vestizione linea 1 Convalida di vestizione LINEA 1 Convalida di vestizione Linea 2 Convalida di vestizione LINEA 2 Ta AC a AC Campionamento operatori eseguito da LB LI a AC Campionamento operatori eseguito da LB LI w AC a NO fj NO f NO fi NO fi NO w AC fj no AC 81 104 fe rc a lex BioTrends User Guide Environmental Monitoring Software System 7 3 Reports and Statistics general functions Through the reports and statistics window it is possible to carry out studies and print complete reports on everything that is related to environmental and personnel microbiological controls For example it is possible to display and print the graphs and Trends of all the sampling operations performed during
79. e of display users are given the possibility of creating groups called Type of points of the body For example we can create the Gloves category in which we will include the right glove and the left glove or the Lower limbs category in which we will include the right knee the left knee the right shoe and the left shoe and so forth In addition it is possible to assign the same acceptance level to a given category and therefore to all the points included in such category Nome File BioTrends 2 3 User Guide docx 31 104 fe rc a lex BioTrends User Guide Environmental Monitoring Software System All in all in order to save the points of the body and or the accessories to be monitored in BioTrends it is first necessary to be sure about the categories into which they will be subdivided and which the acceptance levels for such categories are going to be Insert or Edit Types of Body points at Input of data gt Types of Body points Field Description Figure 29 Insert or Edit Type of Body points 4 2 2 12 Type of Products Products are identified by their Name Company code the country to which they are exported and their acceptance levels The types of product are defined only once and will make up the list of the products launched by the company As the products are being manufactured the Batches that will identify a given parcel of the specific product shall be saved The description may be alpha
80. ext gt gt key Notes i la Import Maps 43 Zoom90 v Move Set the coordinate system for the current map Map C Biotrends WMF TEST wmf 6 Print Select a segment on the map which you know the real length in meters Instructions Move the mouse pointer to the starting point and click to setit Then move the mouse pointer to draw the segment Click the mouse left button to finish lt lt Previous Next gt gt PIANTA PIANO TECNICO A QUOTA 4 0 m Figure 58 Import Maps Determine the reference system Confirm the import operation The procedure is fully assisted by the software To enlarge the image use the zoom key or the scroll wheel To mark the segment that will be used to determine the reference system it is advisable to enlarge the layout as much as it is necessary Once the segment has been marked and the measurement in meters has been entered remember to print the layout using the Print key Before moving on to the following step The print must be preserved and cataloged given that if it has to be updated with a new layout in the future it will be essential to mark an identical reference segment Nome File BioTrends 2 3 User Guide docx 45 104 fe rc N lex l Biolrends User Guide Environmental Monitoring Software System 4 3 2 Area Management Area management is used to associate an area defined in BioTrends at the descriptive level with the
81. fc Corridoio pavimento entrata gt 200 ufc gt 300 ufc Superfici sd Corridoio davanti a loc 12 gt 250 ufc gt 500ufc Aria 1 i 1 Le i Corridoio pavimento davanti a loc 12 gt 200 ufc gt 300 ufc Superfici n th e Ist of sa m p l ng po l nt 3 LE i A sx della comprimitrice gt 250 ufc gt 500 ufc Aria A Kali i Pavimento a sx della comprimitrice gt 200 ufc gt 300 ufc Superfici showed select one define the i c Ack della AE gt 250 ufe gt 500 ufc Aria Le i Pavimento a dx della comprimitrice gt 200 ufc gt 300 ufc Superfici period and click on Trends The P K ed i Granulazione Tra Aeromatic e Azo gt 250 ufc gt 500 ufc Aria LE i Granulazione pav tra Azo e Aeromatic gt 200 ufc gt 300 ufc Superfici i i i Granulazione Zona setacciatura gt 250 ufc gt 500 ufc Aria Tren d of th e selected sam p I ng LG i Granulazione pav zona setacciatura gt 200 ufc gt 300 ufc Superfici z C i Granulazione zona aspirazione gt 250 ufc gt 500 ufc Aria poi nt Wi be d isp ayed i Le i Granulazione pav zona aspirazione e gt 200 ufc gt 300 ufc Superfici Blisteratrice 2 entrata vicino alla bobi gt 250 ufc gt 500 ufc Aria Blisteratrice 2 pav vicino bobina PVC gt 200 ufc gt 300 ufc Superfici Blisteratrice 2 zona recipiente compre
82. fc m3 gt 500 ufc m3 B 12 2 Blisteratrice 2 zona recipiente compresse N C Effervescenti 12 gt 250 ufc m3 gt 500 ufc m3 44 1 Blisteratrice 1 entrata vicino bobina PVC N C Effervescenti 44 gt 250 ufc m3 gt 500 ufc m3 B 44 2 Blisteratrice 1 zona recipiente compresse N C Effervescenti 44 gt 250 ufc m3 gt 500 ufc m3 B 43 1 Conf secondario fine linea BA50 dopo loc 44 N C Effervescenti 43 gt 500 ufc m3 gt 500 ufc m3 43 2 Conf secondario fine linea PRX dopo loc 12 N C Effervescenti 43 gt 500 ufc m3 gt 500 ufc m3 403 1 Corridoio inizio davanti a locale 412 N C Granulari 1 Monuril 403 gt 250 ufc m3 gt 500 ufc m3 Corridoio met davanti a locali 410 e 408 Corridoio fine davanti a locale 405 Granulari 1 Monuril 403 gt 250 ufc m3 gt 500 ufc m3 Granulari 1 Monuril gt 250 ufc m3 gt 500 ufc m3 Nome File BioTrends 2 3 User Guide docx 78 104 fe rc a OX BioTrends User Guide Environmental Monitoring Software System 7 2 2 2 By Department Select the Department desired ag archilex BioTrends ver 2 3 File Tasks Analysis and Trends View Admin Windows Help E Mail E Sampling Points Map Sampling Points Lists aT ae Granulari 1 Monuril p eG Granulari 2 Reports and Statistics Annual Report Alarms environmental samplings Trends Points Effervescenti Action Level Corridoio entrata gt 250 ufc gt 500u
83. ferchilex Culture media batch Basic gt Departments Area Rooms Specific Bacteria Additional Info Devices Temperatures Hours of Incubation Limits Supplier Standard vol Exposure time Measure units Exporting Countries Microorganisms Personnel gt Personnel management Personnel roles Factory Maps gt Areas Management Import Maps Deviations reports Signatures report Option Windows Arrange Help Scelte rapide Index About Biotrends Online Support E Mail Nome File BioTrends 2 3 User Guide docx BiolTrends User Guide Environmental Monitoring Software System 17 104 Felc N lex BiolTrends User Guide Environmental Monitoring Software System 3 3 Quick Access Toolbar In the Quick Access Toolbar are showed icons to open the main application functions de a f Sa t FM BioTrends A SETE Figure 10 Quick access Toolbar Icon Function Quick Access windows Open the Quick access window pop up New Sampling Sessions Allows to open a new Sampling Session List of Samples and Media Shows the list of the activities Reports and Statistics Open the Report and statistic window Alarms Environmental Samplings Shows the list of out of spec result in the last month Sampling Session Shows the list of opened Sampling Sessions Scheduler Opens the Scheduler Module Nome File BioTrends 2 3 User Guide docx 18 104 IC a
84. g 2B09H26 Meropenem 500 mg 2B09H26 Meropenem 500 mg 279 SRPS classe 279 SRPS classe 279 SRPS classe 279 SRPS classe 279 SRPS classe 279 SRPS classe 279 SRPS classe 279 SRPS classe 279 SRPS classe 279 SRPS classe 279 SRPS classe 279 SRPS classe 279 SRPS classe 279 SRPS classe 279 SRPS classe 279 SRPS classe SO OO OO O TO OOO ODO SRPS 1 2 Class gt 70ufc gt 100 ufc enne 1 4 Olaann z 7N ofnl INN fa 26 08 2009 06 0 ne fnofmnnn ne n Spogliatoio sotto flusso remmbi alla narta di an 2B09H26 Meropenem 500 mg 279 SRPS classe NIN CNDC la 26 08 2009 27 08 2009 28 08 2009 31 08 2009 01 09 2009 02 09 2009 03 09 2009 04 09 2009 05 09 2009 07 09 2009 lt m 25 Total count v E Print W 3 Col X 2 Row v aie 24 08 2009 M 07 09 2009 v Statistics of sampling results del fe Data export x gt Figure 109 Statistic of sampling result window The part A is a list of all samplings found The total number of samplings is indicated in the right top corner a It is also possible filter the list using the drop down menu Filter result by b Clicking on one of any column head the drop down list will be willed with the information present in the column Use the key refresh to clear the effect of the filter The part B is made by two
85. g results 7 fe Create and edit Reports Define Report ac EE I a OO Filters summary Reports and Investigations by Environment GSS ______ gt Spogliatoio sotto flusso la Corridoio tra due porte sp Corridoio tra due porte sp Spogliatoio sotto flusso la Spogliatoio sotto flusso la Spogliatoio sotto flusso la AI centro del locale Visual inspection davanti p In mezzo alle due due ma Locale Spare Parts davanti Loc vials decont tra la visi Piano interno macchina ghi Lato destro tunnel di depir Centro del locale Vicino tavolo materiali puliti Centro del locale Davanti alla porta del loc 1 Davanti alle porte dei loc Davanti alla porta del loc 2 Tr fanda al aneridanin 20 bel belie late tel tel hel tel tel Te fells tel de te tele aT Environment om Air i iP Microorganisms Y Product Batch SRPS 1 2 Classe D SRPS 1 2 Classe D SRPS 1 2 Classe D SRPS 1 2 Classe D SRPS 1 2 Classe D SRPS 1 2 Classe D SRPS 1 2 Classe D SRPS 1 2 Classe D SRPS 1 2 Classe D SRPS 1 2 Classe D SRPS 1 2 Classe D SRPS 1 2 Classe D SRPS 1 Classe C SRPS 1 Classe C SRPS 1 2 Classe D SRPS 1 Classe C SRPS 1 2 Classe D SRPS 1 2 Classe D SRPS 1 2 Classe D enne 11 9 Osann n gt 70 ufc m3 gt 70 ufc m3 gt 70 ufc m3 gt 70 ufc m3 gt 70 ufc m3 gt 70 ufc m3 gt 70 ufc m3 gt 70 ufc m3 gt 70 ufc m3 gt 7
86. gt People Oo ON EEE WO WOOO r r r r r r r n r r n r r r r n r n r o O O O O O O O O O O o O o O O O O O O O O O N N N N N N N N N N N N N N N N N N N N N N N N N N N N FS FS FSF FSF F F F F FC SF F F F F F SG Ss a 3 WA A 3 o o o _ Lai _ kad _ Lai heal kad kad Li o S a g F F s 3 SF wf a br f a F 3 a BS N o o _ N n o _ N N o _ _ N _ N o N o _ N o o _ N N o view ana 5 a Clicking on View analysis session key the relative Sampling Session will be showed E p Baste KR Gud Chie Add sampling point trend line on the graph oO Ea Print the graph V V V i Q i Export the graph Show legend ce eS Nome File BioTrends 2 3 User Guide docx 72 104 fe rc a lex l BioTrends User Guide Environmental Monitoring Software System Nn O J E CAUsers Andrea Calda Desktop Trends Air SRPS 1 Classe C Class C Point 20 O GX Trends Ain SRPS1 Gae Gii na File Edit View Favorites Tools Help x amp X W SY Google Fy Google Traduttore Suggested Sites Web Slice Gallery v Web Slice Gallery Suggested Sites v A ia v mp v Pagev Safetyy Toolsv v gt gt Trends Air SRPS 1 Classe C Class C Point 201 C1 from 21 03 20
87. hanks to the Trends function it is possible to display the graphs related to all types of sampling Given that graphs are interactive it is possible from a point displayed on the graph to go back to the sampling detail to display the sampling session or the sampling plan that generated such graph to display the line representing the linear regression to display any potential number of deviations to compare on the same graph two or more points belonging to the same type and area to export the graph with all its details in HTML format iiei iii IL Trends Air Types of Control Areas SRPS 1 Classe C Class C Point 201 C1 N A Trends Air SRPS 1 Classe C Class C Point 201 C1 from 21 03 2007 to 05 01 2008 Type of Control N A to 05 01 2008 z Max value refresh reset Points mn CEF oO k yO oO Zg at Lo Ca f amp e e ORO A asa O Eg I a on C b Lg A les DA dh lt 6 17 11 2007 We 03 2007 04 2007 9 2007 9 2007 Lu 23 06 2007 so 14 04 2007 05 05 2007 12 05 2007 19 05 2007 26 05 2007 02 06 2007 HS 09 06 2007 I 16 06 2007 30 06 2007 07 07 2007 14 07 2007 21 07 2007 28 07 2007 04 08 2007 11 08 2007 18 08 2007 25 08 2007 9 06 10 2007 20 10 2007 L 27 10 2007 LO 03 11 2007 10 11 2007 24 11 2007 gt 01 12 2007 4 08 12 2007 Le 15 12 2007 22 12 2007 29 12 2007 08 0 15 0 22 0 31 21 F a
88. ide Environmental Monitoring Software System 9 Scheduler Module The scheduler module allows scheduling the microbiological monitoring activity easily viewing the alarms for expired o Gowning validation o Instruments calibration o Media batches To open the scheduler window follow one of the methods below 1 Click on the option Tasks gt Scheduler from the main menu 2 Click on the icon in the quick access toolbar i B ii Bi Rio _ oOo N oy Ug gt WwW N i Figure 120 Scheduler main window Nome File BioTrends 2 3 User Guide docx 98 104 fe rc a OX BioTrends User Guide Environmental Monitoring Software System 9 1 Scheduler feature 9 1 1 Scheduler Toolbar Backward Co Today a Forward balabab A Aglalal UU Zoom Out a Day Werk Week jwe 23 Month A Timeline Group By Type Date None View Settings Hide Show Westend Figure 121 Scheduler Toolbar Function Key Description Move the view backward to the previous selected period N Zoom In Move the selection to Today Move the view Forward to the next selected period Increase the Vertical division ss Zoom Out Reduce the vertical division Change the work space in a full day view Change the work space in a week view Change the work space in a week view Change the work space ina month view Nome File BioTrends 2 3 User G
89. igure 53 Create and Edit Analysis sampling plans By choosing Air Surfaces Finished Products etc in the Type drop down list the screen will show all the necessary boxes to define the sampling plan Create and Edit Analysis sampling plans Air Surfaces Finished products Raw materials Water Richiedi firma operatore Compressed gases Cibi tot Personnel Figure 54 Select Type of a new Sampling plan Nome File BioTrends 2 3 User Guide docx 42 104 fe rc a lex BiolTrends User Guide Environmental Monitoring Software System Lal Analysis sampling plans Create and Edit Analysis sampling plans Basic data Type Department Number S O P Schedule Title Richiedi firma operatore Cibi Recording date 1 type Description Recording date Points Area Alert Level Points Area Alert Level BE i B BE em Figure 55 Add elements on a sampling plan e To add one or more elements from the lists select them by clicking on the black box and then click on the key e To remove an element select it and click on the gt key e To remove all the elements in a box click on the Cancel key e Tosave a sampling plan make sure the desired status Active or Draft has been specified and click on the Save key e To modify the general information of an existing sampling plan select an element from the list Fig 12 and click on the option Change from the window menu the screen to modify data wil
90. is user ID to define other users See Defining a new user Every user will be given a password by the administrator users will be forced to change such password the first time they log on the system See Expired Password 2 1 1 3 Nome File BioTrends 2 3 User Guide docx 82 archilex BioTrends ver 2 3 e SQL andreacalda pc 1433 DB biotrends_archilex_eng log in gt gt Figure 3 Log in window User Registration Log In 82 archilex BioTrends ver 2 3 bictre C sofmiere Mia Enter user Name Enter Password Click on the log in key if the data have been correctly entered the change password key and the Enter key will be shown A Click on the Enter key to access BioTrends DB biotrends_archilex_eng IN change password Figure 4 Success Log In window 12 1040 fe rc N OX BioTrends User Guide Environmental Monitoring Software System 2 1 2 Expired Password If once the authentication has been completed a user is given the expired password message proceed as follows 82 archilex BioTrends ver 2 3 alii biotred 1 Enterthe new password Confirm the new password SQL andreacalda pc 1433 DB biotrends_archilex_en 3 Click the change password key you will be 2 chi requested to reenter the password to access the login gt gt in gt gt program N annulla change Figure 5 Changing Password window 2 1 3 Changing the Password If once th
91. ities of the environmental monitoring programs personnel raw materials and finished products in compliance with FDA 21 CFR part 11 The software is primarily but not exclusively aimed at Pharmaceutical Companies The routine tests carried out by the microbiology laboratory in order to detect the possible presence of mildew yeast and bacteria generate a considerable volume of data that can be easily and accurately managed thanks to BioTrends It will make the operators data entry task easier while the laboratory and quality managers will have a powerful tool that they can use in order to plan work carry out their data analyses generate complete reports and export data Sampling data are collected in a structured way by means of the sampling plans defined by the managers in charge which will contain homogeneous elements sorted into groups according to the type of Control Work can be planned then the sampling and analysis activities can be assigned to single operators and programmed in advance During data entry the system will signal possible discrepancies and it will indicate when the acceptance levels are exceeded keeping track of each operation in the audit trail Reports can be automatically created in PDF and XPS and readable electronic reports can be generated through the virtual printer The reports can be easily filed and classified but cannot be modified Thanks to the management of electronic signatures on records BioTrends can be use
92. l be displayed change the desired fields and click on the Save key The modification of a sampling plan data is limited to the plan status Draft gt Active Active gt Obsolete to some descriptive data and to the order of sampling points To modify the order of sampling points select a point from the list and while holding down the right mouse button drag it to the desired position Nome File BioTrends 2 3 User Guide docx 43 104 fe rc a OX BioTrends User Guide Environmental Monitoring Software System 4 3 Company maps or Layout With BioTrends it is possible to manage the specific areas inside the company and the sampling points to be associated with such areas in a visual way through the layout management module In general each pharmaceutical company has the plant layouts in electronic format Before their conversion into standard WMF windows meta file format the files containing the company layouts can be imported and managed in BioTrends BioAdmin and bioSupervisor users see User Management can define the physical areas within a layout and associate them with the areas defined in a descriptive way in the basic data Once the physical areas have been defined it is possible to place the sampling points in their real positions If a Layout is modified e g a wall is moved it is enough to import the new file overwriting the old one 4 3 1 Importing layouts The company layouts may be impo
93. ler 1 Click on the option Tasks gt Gowning validation from the main menu New Samplings Gowning validation List Deviation reports Signatures undo requests i Mic fj New Deviation report Updated 07 02 2012 13 48 01 2 Refresh p Samplings amp Media i Samplings Number 2 Click on Gowning Validation in the Quick access E samping sessions ante 82 i i Signatures undo requests 2011 339 WI ndow EN Trends Exceeding Acceptance Limits i P Sampling Points Alert last thirty days 8 i iL Area Action last thirty days 3 i i Esiconmeni Signatures undo requests i i Air to All 1 to Calda Andrea 1 J x Dei _ i Samplings amp Media a E J Points to sample last thirty days 6 Compressed Gas Media to Read last thirty days 6 i Raw Materials i Finished Products Personnel Gowning amp Alarms environmental samplings amp Reports and Statistics rr mee watiomnonasts mam Le Gowning validation 4 Figure 89A B Gowning validation The list of the Gowning validations falling due ordered by production department will be displayed Choose from the FILTER list in order to have the possibility of displaying Active personnel Expiring a positive value in the column Remaining days until expiry indicates that there are x days left until the validation expires A negative value indicates that the validation expired
94. ling Date aniis ee ee se 07 02 2012 12 10 SJ Number ofitems 1 4 Figure 84A B C D Signature Undo request list Nome File BioTrends 2 3 User Guide docx 63 104 fe rc N lex l BioTrends User Guide Environmental Monitoring Software System The sampling session window related to the Signature Undo request will be showed Click on the key close to the signature to unlock the sampling session Electronic signature Signature UndoSignature Undo Signature Undo Signature reason Closino Samoling session CENE Calda Andrea Password Approval Sampling session jate ite Signature Undo 07 02 2012 12 11 28_ Figure 85 Signature Undo Input User ID and Password and click on Lz The Sampling session is now Unlocked and the datum can be modified 5 3 Gowning Validation BioTrends system is able to manage the Gowning validation expiring for the personnel involved To use this function is necessary to previously create the sampling session template relatives to the gowning validation see Basic Data input Sampling Plans 5 3 1 Starting anew Gowning Validation cycle To active a new Gowning Validation cycle open a new Gowning validation sampling session See Creating new Sampling Session When the sampling session has been opened the list of active personnel window is showed Select the person by click on the name Department N A 5S 0 P No QAS 00 79 fm mh m 1 Somotion wim ties 602 Cont
95. list of all the sampling points identified in a given plant However a sampling point is not identified exclusively by its Name Code and by its description such point is physically located in certain premises a room which in turn are within an Area which in turn is part of a production department In addition each sampling point is associated with the class to which it belongs its acceptance levels etc When a new sampling point is created the data entry window will allow choosing some of these additional attributes from lists that have been previously filled in However if such lists are empty or if they do not contain the desired value for the attribute it will not be possible to save the new point In practice there have to be some pre existing data in order to be able to enter other data For this reason it is very important respect the order in which the necessary information to be used is loaded in the database In order to simplify such data entry it is necessary to fill in the data lists following the predefined order indicated in this document For example before defining a sampling point it is necessary to define its Areas classes acceptance levels etc i e all those data that will make up the attributes of that point 4 1 User Management In BioTrends there are four types of users organized in a pyramid hierarchy bioUser bioMaintainer bioSupervisor bioAdmin To access user management console select the menu Admin
96. lp BioTrends Updated 20 10 i Samplings Number cs cs cos co Points to sample last thirty days Media to Rand last ttarty days info amp Lock Time 59 52 Figure 7 Main Windows In the main window there are several functionalities like main menus quick access toolbar state bar and quick access window which will be described in the following chapters 3 1 Quick Access Window In the Quick Access windows are included shortcuts to the main application functions and some statistical data related to environmental sampling operations Number of analyses performed during the current year and during the whole previous year Number of alert and action levels exceeded over the last thirty days Tasks Updated 13 01 2012 11 5858 Z Refresh Signature cancellation requests complete list of NewSsmelnoseesion i aaron 35 LE i i 2011 330 the requests addressed to the current user ansie ina Da i Alert last thirty d Numbers of point to sampling in the last a Alicia dors 3 thirteenth days xi Pant Points K Signatures undo requests EF MD Environment to Calda Andrea 0 Cll Ar i Samplings amp Media i B eee Points to sample last thirty days 29 Quick access window can be open in a pop up window gw Water Modat Rese sleet nity eye after the access ete Finished Products od Personnel Gowning amp Alarms environmental samplings amp 2 Reports and Statistics b
97. lved in the environmental monitor activities The person that needs to have electronic signature in BioTrends must have the corresponding User configured When a person is 3 A BioTrends USER see 4 1 C List of Default Personnel roles see 4 2 2 25 linked with a specific User is no more possible to change the matching Personnel data input D Personnel Name and z Surname Roles of the Personnel BioTrends B Assigned Roles each person can be assigned one or more roles connected with the tasks they have been assigned by selecting such roles from the default roles C and clicking on List of Default Area Associated Areas Default Areas the key to remove a role select it from the assigned roles and click on the gt key Associated Areas each person can be assigned one or more areas connected with their operations by selecting such area from the predefined Nome File BioTrends 2 3 User Guide docx 40 104 fe rc a lex BioTrends User Guide Environmental Monitoring Software System 4 2 2 27 Raw Material Batches This is the list of Raw material Batches number Wey as gp A RI EAE Input of data Raw Materials batch Field Description value O Batch number Material Order no Supplier Supplier batch Quantity Measure units Status Figure 50 Insert or Edit Raw Material Batch To save a new bat
98. main menu archilex BioTrends ver 2 3 File Tasks View Admin Windows Help E Mail Bi re Sampling Points Map lt Sampling Points Lists gt Raw Materials Finished Products Personnel Gowning Reports and Statistics Annual Report 2 amp OG Alarms environmental samplings The opened window shows the list of sampling point by category ints Fintshed Products Raw Materials Personnel Box 1 Parte centrale Da 360 1 Box 2 Parte centrale 36b c 1 Atrio 364 1 Box 3 entrata 364 2 Box 3 vicino alla bilancia B o i Ricezione merci parte centrale B 92 2 Area lavaggio parte centrale B 10 1 Corridoio entrata ME 10 2 Corridoio davanti a loc 12 102 1 A sx della comprimitrice B 102 2 A dx della comprimitrice B 11 1 Granulazione Tra Aeromatic e Azo 11 2 Granulazione Zona setacciatura B 11 3 Granulazione zona aspirazione B 12 2 Blisteratrice 2 zona recipiente compresse 44 1 Blisteratrice 1 entrata vicino bobina PVC B 44 2 Blisteratrice 1 zona recipiente compresse 403 1 Corridoio inizio davanti a locale 412 403 3 ve Corridoio fine davanti a locale 405 Nome File BioTrends 2 3 User Guide docx B 12 1 Blisteratrice 2 entrata vicino alla bobina PVC 43 1 Conf secondario fine linea BASO dopo loc 44 B 43 2 Conf secondario fine linea PRX dopo loc 12 403 2 Corridoio meta davanti a locali 410 e 408 N C N C
99. ned to a previously associated area Display the desired area by clicking on Load area Ei Maps management Piantine e Aree Show map fave Area Load area Figure 62 Area Management Modifying an Area In the List of areas associated with a map window select and display the area by double clicking on it Holding down the left mouse button while dragging it select the desired area Measure the window in order to optimize the visualization Save the map section that has just been redefined and associate it with the same area that had been previously saved or with a different one 4 3 2 3 Hot Spots Map in map In a map it is possible to create hot spots with which a detailed image can be associated Important The detailed image must have been previously imported and associated with an area See Associating an Area for the first time ES Maps management 1 Display the desired area by clicking on Load area wate Ue Ts 2 Start the procedure by clicking on Add Map 3 Holding down the left mouse button while dragging it select the hot spot 4 Select the area to be associated with the hot spot that has just been defined Piantine e Aree Show map Save Area Load area Mappa nella mappa Add map Delete Map within Map Figure 63 Hot Spot Map in Map Nome File BioTrends 2 3 User Guide docx 47 104 ferchilex 4 3 2 4 Entering the Sampling points In a map it is possible to associate the sampling p
100. nfarioramerts T Locale lauagga pamimant se Sup Sup deb Sap dep us ue te Ser der Sen Sun Ser Sop EEE EELS we piana piana para me Cerritos tra du perte spogliata nord Crerdioio tre dus porte spogluto nord Cameo tre due perte spogiuto ssd Cernooo tre due perte spoyiate sul Aoagiatza cotto Musso innare Spaghatzio sotto fiuzzo laminare Spaghatzio perte aporca Sooghattro parte sporca Sosgiatze cotto Nuno banere Spaglatzio cotto Musso lannere Spaghatio parte sporza Speghater parte sporca Sosghatem sotto Musso lane Soagiatzio cotto Musso laminare Spaghateio perte sporca Spegheters perte sporce Locale storage al contro del locale Locaia torage al camzro Gel pavimento Al camro cel locale Ai centro del sevmerto Tra spertlatrice ax e parete pav fianco spertatrice sx Lita corrida est Tra le fue spertatno Sup perience rx lato comets est Porta pase thetugh ghe Msuni mapecben davanti porte off 124 Visual mapecton daverti porta sft 124 Maro alla porra macctins speriatre Moro elle porre macchme perisos In mezze ale fue due macchine sperlatrio In mazzo ale Gum due macchine spartano Locais Spare Parts davarn alla porta Locate Ssere Parts davero ala perta gt e 15 elder gt 15 ufe 2Scm2 gt e 15 eed gt gt 16 ether gt e 16 edhom se 100 we 230m2 gt 100 ufr 25cm2 gt 100 uty 2Sem2 gt 300 ufe 2Scmi gt e 100 tey dicm gt e
101. ng ibra 25 Ieri 25 Insert or Edit Units of measurement 27 Insert or Edit Acceptance levels 28 Insert or Edit Type of COUN raiscciasenxensaxmnyeamamsmnreanceixe 28 Insert or Edit Types of Method i 29 Insert or Edit Type of Point ii 29 Insert or Edit Class of sampling pointS 30 Insert OF EGIESUPPIE inni 30 Insert or Edit Type of Raw Material n 30 Insert or Edit Type of Media 31 Insert or Edit Type of DEVvices in 31 Insert or Edit Type of Body points 32 Insert or Edit Type of Product ii 32 Insert and Edit Type of Control 32 Insert or Edit Type of Area i 33 Department Area Room hierarchies 33 Insert or Edit Department sisi tirata 34 Input or Edit Areas ariani 34 Insert or Edit ROOMS iii 35 Figure 37 Insert or Edit Specific Bacteria irene 35 Figure 38 Insert or Edit Additional Info iii 36 Figure 39 Insert or Edit Device ii 36 Figure 40 Insert or Edit Temperatures iii 37 Figure 41 Insert or Edit Hours of Incubation ssssssssssrsssrsrsrrrsrrrrssrsrsee 37 Figure 42 Insert or Edit Standard Volume Exposure Time 38 Figure 43 Insert or Edit Air Sampling point
102. ntering the Sampling Points 48 Figure 65 Signature report list 48 Figure 66 Options WINdOW assiali 49 Figure 67 Options window Color Acceptance levels 50 Figure 68 Options window Data INput i 50 Figure 69 Options window Expiring periodS 51 Figure 70 Options window signature ReasonS 51 Figure 71 Options window Automatic Log Off n 52 Figure 72 Options window Customizable field description 52 Figure 73 Options window FileS Folders eessssssssssssssssssesseeeeeeeeeeeeeeseeeeee 53 Figure 74 Options window ApplicatioN i 53 Figure 75 Options window PDA 54 Figure 76 Tasks MENU ara 55 Figure 77A B C D E F G New Sampling session procedure 57 Figure 78A B C List of sampling session procedure 58 Figure 79A B C Sampling points and Plate procedure 59 Figure 80 List of Sampling point and Plate 59 Figure 81A B Closing a Sampling SEssion i 60 Figure 82A B C Changing datum iii 61 Figure 83A B C D E Signature Undo request procedure 62 Figure 84A B C D Signature Undo request list n 63 Figure 85 Signature Undo ii 64 Figure 86 New
103. numeric Peter Eee Type or Product AEJ Input of data A Types of Product Field Description vale o Name Company code Export country Bacteria limit Fungi Limits Figure 30 Insert or Edit Type of Product 4 2 2 13 Type of Control The Type of control list is used to define the other production steps In this way when the data related to a sampling session are entered it will be possible to specify the time at which sampling has been carried out The description may be alphanumeric amp Insert or Edit Types of Control 8 Input of data A Types of Control Field Description Figure 31 Insert and Edit Type of Control Nome File BioTrends 2 3 User Guide docx 32 104 ferchilex 4 2 2 14 Type of Area BioTrends User Guide Environmental Monitoring Software System These are the types of area Some types are prefilled It is possible to use or modify the information The description may be alphanumeric E Types of Control Types of Area Filter results on amp Insert or Edit Types of Area Add Change Print Expc Types of Count Types of Method E Type AN NON STERILE STERILE Types of Area 5 27 01 2012 15 10 4 2 2 15 Departments Input of data Figure 32 Insert or Edit Type of Area In BioTrends the plant is ideally divided according to hierarchies Plant gt Departments gt Areas gt Rooms gt Sampling points E Number ofitems 2 4 m a
104. o the relevant sampling session Nome File BioTrends 2 3 User Guide docx 59 104 Environmental Monitoring Software System fe rc a OX BioTrends User Guide 5 1 4 Closing a Sampling Session At the end of the Sampling activity is necessary to close each sampling session to make data available in the statistics and report function To close the sampling session the electronic signature must be applied on the specific box The User level needed to close a sampling session is defined in the Options Signature Reasons Electronic signature Closing Sampling sessionClosing Sampling session gt Closing Sampling session 4 A biotrendsadmin Z Password Closing Sampling session Meaning Closing Sampling session Date Ei 07 02 2012 11 16 07_ Figure 81A B Closing a Sampling session Approval Sampling session Clicking on the key the electronic signature window is showed Enter User ID and Password then click on As soon as the signature for Closing Sampling session is applied the data will be available for trending statistic and reporting function A second electronic signature may be applied for Approval Sampling session The user level must be BioSupervisor or BioAdmin The signature to Approve the sampling session can be applied only if the first signature Closing Sampling Session has been done and must be different The same User can t Close and
105. oTrends 2 3 User Guide docx 95 104 fe rc a lex BioTrends User Guide Environmental Monitoring Software System 8 Bar Code Module Barcode module if installed allows the BioTrends mobile software installed on the PDA See BioTrends Mobile User Manual connecting to the system and exchange data allows the BioTrends printing the labels with a data matrix of a definite value The Barcode print function is active in some list and can be identified by the key Print Barcodes archilex BioTrends ver 23 File Tasks Analysis and Trends View Admin Windows Help E Mail Bio Trends ASS ee FRY Print barcodes Culture media batch Actives Culture media batch 2 Raw Materials batch Products batch Batch No loTr 31 12 2013 00 00 00 test321 29 01 2013 00 00 00 test123456 Te 05 01 2013 00 00 00 10 02 2012 08 42 Number of items 3 info amp Lock Time 59 54 Figure 118 List Windows with Print Barcode function active When the user click on the specific key a window showing the list of the labels template is displayed st rie i arCode Labels 83 Click on the key Title TEST 1 The Template Setup esta zool soo ao ao e oe M OEeEeESElllmm lt information will be showed h_ 8 Preview Cs je ss File View Background Hila e a CF M A m Mali d PZA Depending on the list is showed clicking on Click on this key to modif
106. oints that have been previously defined see Data lists Sampling points Type Add point Refresh points Move point Delete point oi BiolTrends User Guide Environmental Monitoring Software System Sampling points Type D Air analysis BB Surfaces D Water D Compressed Gas Delete point Figure 64 Area Management Entering the Sampling Points In the Maps and Areas section from the general menu select and display the desired area by clicking on Load area In the Sampling points section from the general menu select the Type of point from the drop down menu Click on add point and select the desired point from the list that will be shown Position the point on the area It is possible also to Move a point previously added on the map in a new position or delete a point These actions are tracked in the Audit Trail and will be required to input an explanation 4 4 Signature Report The signature report can be used to display the list of all the electronic signatures affixed in BioTrends Select the option Admin gt Signature Report from the main menu archilex BioTrends ver 2 3 Bio Trenf The list of all the signatures will be displayed Signatures Report e N hi LA x a a a LA a a a a a a u a a a a a s a a a a a a a a a a a a a a a a a 282 Contr ind Controllo indumenti Linea 2 282 Contr ind Controllo indumenti Linea 2 282
107. orridoio da O SRPS 1 2 Class SRPS 1 2 Class SRPS 1 2 Class SRPS 1 2 Class SRPS 1 2 Class SRPS 1 2 Class SRPS 1 2 Class SRPS 1 2 Class SRPS 1 2 Class SRPS 1 2 Class SRPS 1 2 Class SRPS 1 2 Class SRPS 1 2 Class SRPS 1 2 Class SRPS 1 2 Class SRPS 1 2 Class gt 70 ufc gt 70 ufc gt 70 ufc gt 70 ufc gt 70 ufc gt 70 ufc gt 70 ufc gt 70 ufc gt 70 ufc gt 70 ufc gt 70 ufc gt 70 ufc gt 70 ufc gt 70 ufc gt 70 ufc gt 70 ufc gt 100 ufc gt 100 ufc gt 100 ufc gt 100 ufc gt 100 ufc gt 100 ufc gt 100 ufc 26 08 2009 06 0 26 08 2009 06 0 26 08 2009 06 0 26 08 2009 06 0 26 08 2009 06 0 26 08 2009 06 0 26 08 2009 06 0 26 08 2009 06 0 26 08 2009 06 0 26 08 2009 06 0 26 08 2009 06 0 26 08 2009 06 0 26 08 2009 06 0 26 08 2009 06 0 26 08 2009 06 0 26 08 2009 06 0 2B09H26 Meropenem 500 mg 2B09H26 Meropenem 500 mg 2B09H26 Meropenem 500 mg 2B09H26 Meropenem 500 mg 2B09H26 Meropenem 500 mg 2B09H26 Meropenem 500 mg 2B09H26 Meropenem 500 mg 2B09H26 Meropenem 500 mg 2B09H26 Meropenem 500 mg 2B09H26 Meropenem 500 mg 2B09H26 Meropenem 500 mg 2B09H26 Meropenem 500 mg 2B09H26 Meropenem 500 mg 2B09H26 Meropenem 500 m
108. pliers This is the list of materials suppliers like culture media and raw materials For each supplier is required to select also the barcode type The Barcode types are system information and it is not possible edit or adds them If the supplier doesn t use barcode technology select BioTrends Culture media as Barcode type Insert or Edit Supplier EJES Input of data Supplier Field Description vale O Name Barcode Type Biomerieux 1 Heipha 1 BioTrends Culture Media Carewell Lab Figure 25 Insert or Edit Supplier 4 2 2 8 Type of Raw Material They are used to define the types of Raw Materials used by the plant This information is used to enter the corresponding batches that will be analyzed To define the Type of Raw material is request to input also the microbiological limits for Bacteria and Fungi me Insert or Edit Types of Raw material AEJ Input of data A Types of Raw material Field Description Type Bacteria limit Fungi Limits Figure 26 Insert or Edit Type of Raw Material Nome File BioTrends 2 3 User Guide docx 30 104 fe rc a lex BiolTrends User Guide Environmental Monitoring Software System 4 2 2 9 Type of media The types of media information are the different classes of growth media that are used for microbiological analyses The types of media are entered only once and they will be used when defining sampling plans in order to indicate which cult
109. possible to close it specifying the Closed status A Deviation that has been opened by mistake or due to any other reason can be declared to be OBSOLETE by setting the corresponding STATUS field The data of a deviation report can be modified by calling up the report from the list of Deviation Reports 5 4 1 Creating a deviation report 1 Click on the option Tasks gt New gt Deviation 2 Report from the main menu 2 Click on the option Admin Deviation Report from the main menu archilex BioTrends ver 2 3 File Tasks Analysis and Trends View Admin Windows Help E Mail archilex BioTrends ver 23 File Tasks Analysis and Trends View Admin Windows Help E Mail BioTrenAs Users management New Deviation report I a Updated 07 02 2012 13 48 01 2 Refresh J 5 r E ar pesi lesi Das i Samplings Number 3 Click on New Deviation Report in the Quick aa Sampling sessions 2012 82 i i Signatures undo requests 2011 n 339 access WIN d OW A Trends amp Exceeding Acceptance Limits i Sampling Points Alert last thirty days 8 TE ET Area Action last thirty days 3 i LD Environment Signatures undo requests i i Air to All 1 a PRETE to Calda Andrea 1 Water _ i Samplings amp Media pi F Points to sample last thirty days 6 i a R sat Pina as Media to Read last thirty days 6 ca aw Materials i Finished Products ud Personnel Go
110. real area in a layout To access to Area management click on the menu Admin gt Factory Maps gt Area Management Mappa nella mappa Add map Delete Map within Map Gal PIANTA PIANO TECNICO A QUOTA 4 0 m Window size Width 1443 Height 893 Coordinate X 19729 Y 12386 Figure 59 Area Management 4 3 2 1 Associating an Area for the first time Et Maps management Select from the drop down menu the layout among the ones that are available by clicking on the Show map option To display the layout double click on it Piantine e Aree Show map Save Area Load area Figure 60 Area Management Associating an Area Holding down the left mouse button and select the desired area r r Ol CENTRALINE TERMOSTATAIONE sr E a si Note holding down the left mouse button and dragging it on the map a Sg the layout will be displayed again with its original dimensions Resize the window in order to optimize the visualization Click on Save area to save the map section that has just been defined and associate it with an area previously defined at the descriptive level mo pelts Figure 61 Area Management Save an Area Nome File BioTrends 2 3 User Guide docx 46 104 fe rc a lex BioTrends User Guide Environmental Monitoring Software System 4 3 2 2 Modifying an Area This function allows modifying a layout area assig
111. ria Additional info Devices S Insert or Edit Rooms Input of data A Rooms Field Description ve si a i Area 27 01 2012 15 5 Figure 36 Insert or Edit Rooms 4 2 2 18 Specific Bacteria These are the specific microorganism found with a selective media in the water analysis or in the product analysis E Departments GITE Speafic Bacteria Filter Refresh Print Export Cancel Ok Departments Areas Rooms ESEE additional info Devices Temperatures Hours of Incubation Limits Supplier Standard vol Exposure time Measure units Exporting Countries Microorganisms N Ca om 2 Insert or Edit Specific Bacteria Input of data A Specific Bacteria Field Description C _ __ _____ _ _ 9 27 01 2012 17 53 Figure 37 Insert or Edit Specific Bacteria Nome File BioTrends 2 3 User Guide docx 35 104 fe rc a lex BioTrends User Guide Environmental Monitoring Software System 4 2 2 19 Additional Info This additional information is an attribute used in the product analysis session For example if should be recorded an intermediate reading or a different dilution analysis etc Additional info Input of data Additional info Field Description vale __ 5 27 01 2012 17 57 Figure 38 Insert or Edit Additional Info 4 2 2 20 Device These are the instrument used in the environmental monitoring activity like active air
112. rmis thuringiensis kristinae kristinae kristinae kristinae varians varians varians varians varians varians varians varians varians varians 08 09 2009 17 09 00 31 08 2009 07 47 00 07 10 2009 07 15 00 22 09 2009 08 15 00 30 07 2009 09 45 00 25 06 2009 06 40 00 02 07 2009 06 39 00 24 06 2009 06 24 00 23 09 2009 07 00 00 14 07 2009 21 35 00 14 07 2009 21 35 00 14 07 2009 21 35 00 18 07 2009 07 15 00 20 07 2009 21 45 00 05 10 2009 20 35 00 06 10 2009 20 40 00 03 09 2009 00 00 00 22 07 2009 06 41 00 Linea 2 Classe B Linea 1 Classe B Linea 1 Classe A Linea 2 Classe B IMA Linea 1 Classe B Linea 1 Classe B Linea 2 Classe B Linea 1 Classe A Linea 1 Classe B Linea 1 Classe B Linea 1 Classe B Linea 1 Classe B Linea 1 Classe B Linea 1 Classe B Linea 1 Classe B Linea 1 Classe B Linea 2 Classe B TSE ax Create and edit Reports m elegge dg gg Filter results by PNR RP RP RP RP PN WON PN RE BPR RR wy ovom oov om rovor orog Kucuria varians 27 07 2009 08 48 00 Linea 1 Classe B Results Results by genus Detail of species muffa genere aspergillus xylosus Staphylococcus warneri Micrococcus sciuri Muffa gen penicillinum fi saprofiticus staphilococcus lugdunensis Kokuria kloosi Bacillus haemolyticus Kocuria epidermidis cohnii cohnii cohni cohni Alicyclobacillus 3 z caprae Paenibacillus 1 z capitis Sor WHR NW onuwuat Pure n ps eN NANG S Print
113. rolled Operator Sa li lan Title G ni Validati Li Lieg Lera paba su Calda Andrea 07 02 201214 25 li _ IC en GG GG SS SSS SS Se z Sampling Date SS e Failed In progress Figure 86 New Gowning Validation Cycle Automatically the Sampling session assign a number of the test The column result is filled automatically It is showed Failed until all the result are inputted and if one of the result is bigger than acceptance levels Nome File BioTrends 2 3 User Guide docx 64 104 fe rc N lex l BioTrends User Guide Environmental Monitoring Software System Sampling Date When all the criteria are met the value become Passed automatically It is 07 02 2012 14 25 19 possible now to close the sampling session see closing a sampling session Depending on the company procedure is possible now close the Gowning validation Cycle See close Gowning Validation Cycle or perform another test If the cycle is not closed when the sampling session for Gowning validation is opened and is assigned to the same person the system automatically assigns a progressive test number Schedule Samplings starting Appointed Operator Controlled Operator 07 02 2012 14 44 0 _ Calda Andrea Personnel gowning validation Sampling Date 07 02 2012 14 38 24 Passed Active 2 07 02 2012 14 44 09 Failed In progress Figure 87 Gowning Validation Test Number box Repeat the steps until the number of the Tests in yo
114. rom the effective expiration date BioTrends shell indicate the expiring of an item coloring the items itself on red Options Application PDA g7 Signatures reasons M Files Folders Expiring periods amp AutomaticLog Of Colors of acceptance levels Expiring periods Customizable Fields Description A Data Input Gowning validation Culture media batch Devices Allows to specify until items or devices having an expiration date calibration date is possible to use di kl Ok Cancel Bappy Figure 69 Options window Expiring periods 4 6 4 Signature reasons lt can be used to specify the qualifications of the personnel that will sign the reports generated with BioTrends for their approval or control and the default meanings for the different types of signatures that can be affixed in BioTrends It is possible also to set the minimum User level allowed signing a sampling session Options Customizable Fields Description W Files Folders Application A PDA SJ Datalnput Expiring periods a Signatures reasons amp Automatic Log Off Colors of acceptance levels Signatures reasons User minimum level allowed to sign Opening of a sampling session Sampling start Sampling end Incubation 1 Incubation 2 Incubation 3 Reading result of sampling Reading result of LAL Test Reading result of identifications Re
115. rted by click on the menu Admin gt Factory Maps gt Import Maps The window to perform the import will be shown ta Import Maps Zoom 200 v Move GF Print Select map 1 Select Import new map to insertin BioTrends a new file Select Replace an existing map to update a picture of anewsting map C Importnew map X 12 Y 300 Figure 56 Import Maps window The information box shows the instructions to import a new layout i e a layout that has never been imported before or to update a layout that is already present in BioTrends The import will consist in following a short guided procedure A Open the file to be imported by select Import new map then click on Next gt gt key Biotrends ss Te Select a segment on the map which you know the real length in meters Instructions Move the mouse pointer to the starting point and click to set it OK Figure 57 Import Maps istructions Nome File BioTrends 2 3 User Guide docx 44 104 fe rc N lex BiolTrends User Guide Environmental Monitoring Software System Determine the reference system by designing a segment on the layout and indicating which the corresponding real measurement is Important The segment origin will be used as origin and its length will be used to determine the unit of measurement of the coordinate system corresponding to the imported layout move forward by click on N
116. s Edit Directory path for Temporary files Mapplication server TMP Directory path for Maps Temporary files etc Li Ok EPCancel Apply Figure 73 Options window Files Folders 4 6 8 Application It is possible to set the following parameters Options Colors of acceptance levels E Data Input Expiring periods Signatures reasons amp AutomaticLog Off Customizable Fields Description Files Folders Application A PDA Application Edit Language Reports columns per page Use SMTP for sending E Mail D bi Ok Cancel Appy Figure 74 Options window Application Nome File BioTrends 2 3 User Guide docx 53 104 ferc a l OX BioTrends User Guide Environmental Monitoring Software System 4 6 9 PDA It is possible to set the following parameters Options SY Signatures reasons 4 Data Input Expiring periods fd PDA Colors of acceptance levels MW FilesFolders Application amp Automatic Log Off Customizable Fields Description PDA iame______ __ _ _ a o e e um e o0a aOo am Leer h Edit BioTrends BioTrends Culture Media Default media Request signature for each samplings group Synchronize the last xx days Synchronize the next xx days Show data from the last xx days QD kl Ok amp Cancel Apply Figure 75 Options window PDA Nome File
117. s 2 3 User Guide docx 37 104 fe rc a lex BioTrends User Guide Environmental Monitoring Software System 4 2 2 23 Standard Volume Exposure Time Standard volumes constitute an attribute of Active Air sampling points and represent the air volume expressed in liters or cm3 to be sucked for sampling through MAS or SAS Exposure time constitute an attribute of Static Air sampling points and represent the hours of exposure Standard vol Exposure time Refresh Change Print Export Cancel Ok Departments Areas Rooms Specific Bacteria Additional info Devices Temperatures Hours of Incubation Limits Supplier RELEEGNQORE STATA Measure units Exporting Countries Microorganisms S Insert or Edit Standard vol Exposure time Input of data AN gt Standard vol Exposure time Field Description Ra OE P E EE E E 9 27 01 2012 17 47 Figure 42 Insert or Edit Standard Volume Exposure Time 4 2 2 24 Sampling points These are the lists of the sampling point used in the environmental monitoring activity The sampling points are dived in different categories e Air points e Body points e Water points e Surfaces points e Compressed gas points For each of these categories is request to insert all the information It is not possible to leave any field empty The Number of each sampling point shell be unique and will be used to identify the specific sampling point in the reports Insert or Edi
118. sampler or incubator or filtration ramp etc BioTrends can also manage the calibration expiring E Departments Devices Change P xport Departments Areas ific Bacteria Additional info Model r Insert or Edit Devices Input of data gt Devices Field Description vet Serial number Calibration Type Status 27 01 2012 18 04 Figure 39 Insert or Edit Device Nome File BioTrends 2 3 User Guide docx 36 104 fe rc a lex BioTrends User Guide Environmental Monitoring Software System 4 2 2 21 Temperatures These are the degrees range of the incubation temperatures Temperatures Microorgan ancel O isms x Input of data A Temperatures Field Description vale ______________ E Degrees range Measure units 27 01 2012 16 41 Figure 40 Insert or Edit Temperatures 4 2 2 22 Hours of Incubation These are the length of incubation express in hours Hours of Incubation rint Export Cancel Ok Change P Export ance Departments Areas Rooms Specific Bacteria Additional info Devices Temperatures Etec cea Limits Supplier Standard vol Exposure time Measure units Exporting Countries Microorganisms Hours n eccesina data Z Insert or Edit Hours of Incubation Input of data gt Cancel ll Save Close Hours of Incubation Hours of Incubation J oy 27 01 2012 17 17 Figure 41 Insert or Edit Hours of Incubation Nome File BioTrend
119. ss and or completed click on the option Tasks gt Sampling gt Sampling Sessions from Mew 29 Scheduler the main menu Samplings Samplings Media Gowning validation E Sampling sessions List Deviation reports Signatures undo requests 2 Click on the icon in the quick access toolbar 3 Click on Sampling Sessions in the Quick access ps a Updated 13 01 2012 11 56 56 Z Refresh DE 4 New Sampling session i Samplings Number WI ndow New Deviation report 2012 35 gw ame Ra Saia tian 2011 330 i Sampling sessions I Exceeding Acceptance Limits PUSS eee ts Alert last thirty days 7 Al Trends Action last thirty days 3 i Sampling Points Signatures undo requests i E pre to All 0 i ii Ar a to Calda Andrea 0 nvironment i z ll Ar 1 Samplings amp Media 5 Points to sample last thirty days 29 os Surfaces Media to Read last thirty days 2 Water i Compressed Gas Raw Materials Sal Finished Products ud Personnel Gowning Alarms environmental samplings rr Sat Etos Solen ie Figure 78A B C List of sampling session procedure The Sampling sessions List window will be displayed Choose from the FILTER list in order to have the possibility of displaying a In Progress the sampling sessions that are totally or partially filled in by operators and analysts but which have not been declared to be complete 194 18 03 2011 14 30 00 b A
120. stem 7 3 3 3 GRAPH from Values Frequency A 1ColX1 Row In the value Frequency view click on key to obtain the graphs showing the frequency of values X archilex BioTrends ver 2 3 BioTrends reports and statistic ole amp File Tasks Analysisand Trends View Admin Windows Help E Mail BioTrends a a P p JA C VE Create and edit Reports O d Define Report Results Graphs Statistics of sampling results Results frequency 104 01 B 107 02 o 107 05 m 109 01 E 111 01 info Lock Time 09 54 archilex BioTrends ver 2 3 BioTrends reports and statistic Lo e File Tasks Analysisand Trends View Admin Windows Help E Mail BioTrends a e x Create and edit Reports 2 Define Report Results Graphs Statistics of sampling results Results frequency Print AJ1 Col X1 Row from So 10 2009 Statistics of sampling results z Data export ot gt info B Lock Time 09 55 Figure 113 Reports and Statistic Histogram and Pie of Values frequency Using the graph Toolbar is possible Print the Graph or change the type of histogram viewed Nome File BioTrends 2 3 User Guide docx 90 104 BioTrends User Guide Environmental Monitoring Software System ferchilex 7 34 Report for Sampling results statistics Depending on the section showed is possible to obtain different printable report Using the drop dawn men
121. t Air JEJ Input of data Air Number Room Class Area Description Standard vol Exposu Limits Department Method Figure 43 Insert or Edit Air Sampling point Nome File BioTrends 2 3 User Guide docx 38 104 fe rc a lex BioTrends User Guide Environmental Monitoring Software System OTT ge ys Ce ss Input of data A Body points Figure 44 Insert or Edit Body sampling point ety ia Input of data Water Field Description a SOS Figure 45 Insert or Edit Water sampling point Me Insert or Edit Surfaces Cet Input of data A Surfaces Figure 46 Insert or Edit Surface sampling point Nome File BioTrends 2 3 User Guide docx 39 104 fe rc a lex BiolTrends User Guide Environmental Monitoring Software System Insert or Edit Compressed Gas EJES Input of data Compressed Gas Number Room Class Area Description Type Compressed Gas Limits Department Figure 47 Insert or Edit Gas Compressed sampling point 4 2 2 25 Roles of the Personnel The roles of the personnel are an attribute used to define the company personnel in the personnel management Should be entered the description Insert or Edit Personnel roles PI Input of data gt Personnel roles Field Description Figure 48 Insert or Edit Roles of Personnel 4 2 2 26 Personnel Management This is the list of the person in the company invo
122. t Samplings Media from the main New menu Samplings E Samplings Media Gowning validation E Sampling sessions List Deviation reports Signatures undo requests 2 Click on the icon in the quick access toolbar la i amp Updated 13 01 2012 11 56 56 I sa 3 Click on Samplings amp Media in the Quick access New Samping session i Samplings Number gp 2012 35 Samplings amp Media I 2011 330 win d OW ie Pitas as amp Exceeding Acceptance Limits i Signatures undo requests Alert last thirty days HA Trends Action last thirty days 3 Is MD Sampling Points Z Signatures undo requests i EE Area L to All 0 IP Environment F z to Calda Andrea 0 i Air 1 Samplings amp Media i Points to sample last thirty days 29 ME Sacs Media to Read last thirty days 2 J Compressed Gas i Raw Materials i Finished Products 2 Personnel Gowning Alarms environmental samplings e te Figure 79A B C Sampling points and Plate procedure The corresponding window will be displayed Choose from the FILTER list in order to have the possibility of displaying a Points to sampled b Media to incubate 1 incubation c Media to read or move end 1 incubation d Media to read 2 incubation DI Number of terns 1223 gt 10 02 2012 1233 Figure 80 List of Sampling point and Plate Double click on one element from the list to display the window corresponding t
123. tabs 1 Result 2 Statistic 7 3 2 1 Result Tab features In the Result tab are listed the Total count result by Date Point The first column is the result average of the day See Fig 107 part B Using the Result toolbar is possible Total count Print A 3 Col X 2 Row a b C a Change the result showed from E toticomi amp Pr 1 Col X1 Row 2 Col X1 Row Total count f 3 Col X1 Row Bacteria count i 2 Col X 2 Row Fungi count 3 Col X 2 Row 4 Col X2 Row A 3 Col X 3 Row Print a report of result by Date Point avi c Display the Trend of the result It is possible to select the lay out of compareAali the view Selecting Compare All all the sampling point trend will be 3 CotX2 Row compared on the same graph Nome File BioTrends 2 3 User Guide docx 85 104 fe rc a lex BioTrends User Guide Environmental Monitoring Software System 7 3 2 2 Statistics Tab Features In the Statistics tab are listed some statistic of the result by point Results i Total Statistics Count by Date Point info SSCS ALL POINTS soa 202 01 301 03 123 03 o 12201 Sampling no 174 2 2 2 2 2 2 2 10 Average 9 51 28 4 6 2 0 2 8 11 7 Dev standard 15 839421 22 627417 0 8 485281 2 828427 0 2 828427 11 313708 16 499495 Max value 123 44 4 12 4 o 4 16 45 Min value 0 12 4 0 0 0 0 0 0 Results equal to zero 52 0 0 1 1 2 1 1 1 Results equal to zero
124. tches Lists of Sampling plans 4 2 2 1 Admin gt Lists gt Personnel Admin gt Lists gt Batches Admin gt Lists gt Batches Admin gt Lists gt Batches Admin gt Lists gt Sampling Plans Units of measurement BioTrends User Guide Environmental Monitoring Software System They constitute an attribute for those elements in which a quantity has to be expressed For example the acceptance levels or the quantity of a batch of raw materials The attribute value is selected from the predefined list Units of measurement Measure units dd Change Prin Departments Areas Rd Units C oF EU g EU ml EU ml 1000 g ufc 100mL ufc 10g ufc 25cm2 ufc filter ufc g ufc glove ufc m3 ufc mL ufc plate ufc plate 4hours ufc unit 5 23 01 2012 14 25 Nome File BioTrends 2 Lo JLo Measure units Insert or Edit Measure units Input of data D Measure units Field Description Figure 19 Insert or Edit Units of measurement 3 User Guide docx 27 104 fe rc a lex BioTrends User Guide Environmental Monitoring Software System 4 2 2 2 Acceptance Levels They constitute an attribute for the sampling points and specific bacteria that are sought in some types of sampling The attribute value is selected from the predefined list Acceptance levels According to the categories and classes to which they belong sampling points will have some common acceptance
125. ts Lists Raw Materials In the list of sampling point showed select one define the period and click on Trends The Trend of the selected sampling point will be displayed Trends punti aria Box 1 Parte centrale gt 250 ufc m3 Box 2 Parte centrale N C 36c gt 250 ufc m3 36b c 1 Atrio N C Dispensing 36b c gt 250 ufc m3 gt 500 ufc m3 Q 364 1 Box 3 entrata N C Dispensing 36d gt 250 ufc m3 gt 500 ufc m3 B 364 2 Box 3 vicino alla bilancia N C Dispensing 36d gt 250 ufc m3 gt 500 ufc m3 o 1 Ricezione merci parte centrale N C Effervescenti 9 gt 250 ufc m3 gt 500 ufc m3 B 02 2 Area lavaggio parte centrale N C Effervescenti 30dec99 gt 250 ufc m3 gt 500 ufc m3 B 10 1 Corridoio entrata N C Effervescenti 10 gt 250 ufc m3 gt 500 ufc m3 B 10 2 Corridoio davanti a loc 12 N C Effervescenti 10 gt 250 ufc m3 gt 500 ufc m3 B 102 1 A sx della comprimitrice N C Effervescenti 10a gt 250 ufc m3 gt 500 ufc m3 B 102 2 A dx della comprimitrice N C Effervescenti 10a gt 250 ufc m3 gt 500 ufc m3 Qi Granulazione Tra Aeromatic e Azo N C Effervescenti 11 gt 250 ufc m3 gt 500 ufc m3 011 2 Granulazione Zona setacciatura N C Effervescenti 11 gt 250 ufc m3 gt 500 ufc m3 i1 3 Granulazione zona aspirazione N C Effervescenti 11 gt 250 ufc m3 gt 500 ufc m3 B 12 1 Blisteratrice 2 entrata vicino alla bobina PVC N C Effervescenti 12 gt 250 u
126. u Select and double click on the desired sampling plan the data entry window corresponding to the chosen sampling plan will be displayed fa messa esn A 09 01 2012 16 54 13 01 2012 16 54 E Export Audit Trail X Cancel Close The box at the top right hand corner will show the list of the sampling sessions performed during the last seven days the time interval can be modified click on Refresh to obtain the new list Select the session to be viewed using the key lt lt gt gt to move up and down in the list or just click on the corresponding line Click on View key to open the selected sampling page Nome File BioTrends 2 3 User Guide docx 70 104 fe rc a OX BioTrends User Guide Environmental Monitoring Software System 7 Analysis and Trends of Data With BioTrends it is possible to display trends carry out studies correlate data and create reports in relation to the sampling operations performed In addition with a few clicks it is also possible to print the Annual Report i e the trends and or all the Deviations related to all the sampling operations performed during the year archilex BioTrends ver 2 3 View Admin Windows Help E Mail Et Sampling Points Map E Sampling Points Lists Raw Materials Finished Products Personnel Gowning Reports and Statistics Annual Report Alarms environmental samplings Figure 97 Analysis and trends menu 7 1 Trend general functions T
127. u in the reports and statistics toolbar is possible to select the report needed archilex BioTrends ver 2 3 BioTrends reports and statistic File Tasks AnalysisandTrends View Admin Windows Help E Mail x ns BioTrends Create and edit Reports Define Report Results Graphs Alet Action Becteria Fungian Count ResuttT Exceeding Date Deviations Batch Sampling plan gt 70 ufc m3 gt 100 ufc m3 Acceptable 25 06 2009 14 20 00 2A09F25 Meropenem 1000 mg 1A 279 SRPS classe DA gt 70 ufc m3 gt 100 ufa m3 25 06 2009 14 20 00 2A09F25 Meropenem 1000 mg 1A 279 SRPS classe DA gt SRPS 1 2 Classe D SRPS 1 2 Classe O Spogliatoio sotto flusso lami Spogliatoio sotto flusso lami Acceptable Corridoio tra due porte spog Corridoio tra due porte spog Ar Spogliatoio sotto flusso lami Spogliatoio sotto flusso lami Spogliatoio sotto flusso lami Corridoio tra due porte spog Ari Corridoio tra due porte spog Spogliatoio sotto flusso lami Corridoio tra due porte spog Spogliatoio sotto flusso lami Spogliatoio sotto flusso lami Spogliatoio sotto flusso lami Corridoio tra due porte spog SRPS 1 2 Classe D SRPS 1 2 Classe D SRPS 1 2 Classe D SRPS 1 2 Classe O SRPS 1 2 Classe D SRPS 1 2 Classe D SRPS 1 2 Classe D SRPS 1 2 Classe D SRPS 1 2 Classe D SRPS 1 2 Classe D SRPS 1 2 Classe D SRPS 1 2 Classe D
128. uide docx 99 104 BioTrends User Guide Environmental Monitoring Software System P rotin x Gens E ke Aann ias Samisi iia iena Jom Fp wminees ED kanndi CD banati O inad comi Tie De Sere mews Aret 27 itron 2012 amet 3 ammo INIT Wet 3 anm 202 at 12 manto INI wet LI cee M eee eee III Cotone eee dl mar Deer 100 iwel dub acum Sin Gear rem ega Wren iubise iha 1mm ieme tS go ivm 17 000 nee Lema Timeline Change the work space in a ail Timeline view Spada r E teres C Lonii tomes Ci Santali domo ED La ma Ow re resine omni tomo sar tee re treme setae nr mee Depending on the view selected Sea T group by Type of category e Sampling Session e Device Culture Media Batch Gowning Validation Note inni rese fine di A maoa lend os Cm me twee omni Type Ben Home sem suraman pata tane E 1a mems anao aam imme amema sarm me edo er a rl pendii ao Depending on the view selected group the Type of category by date Remove any group selected before Pte i n pane Geet E tor p roemes Geet GL teen EJ CT rien TY ate CT rime em ee ce e vm tig ci nt wee nee neri wee 5 Gees Ee ewe S aaoo C eer O t mt C ee aaan Oh erama my Mpe Daae aasa mew manag res menee e god I I persi Lamao rozza i In the Work week or in the Month view hide the week end from the view ae mg non den ee e ma et dr
129. unt Point Aria 312 C1 C Spogliatoio entrata centro del locale Lato destro tunnel di depirogenazione Total count Point Aria 212 C1 C 707 109 2009 00 9 Q 02 09 2009 10 A 9 0 09 2009 00 28 08 2009 00 21 08 2009 00 10 08 2009 00 SRPS 1 Classe C 30 07 2009 06 26 07 2009 00 28 08 2009 00 21 08 2009 00 10 08 2009 00 I 1 r I 1 L 30 07 2009 06 26 07 2009 00 22 07 2009 00 1 7 07 2009 00 11 07 2009 08 7 07 2009 10 28 06 2009 00 4 06 2009 00 m 02 07 2009 15 E a D Data export ing results Statistics of sampl FISSA 24 06 2009 IR 07 10 2009 amp Lock Time 09 25 Info Figure 111 Reports and Statistic Trends of sampling results the others are one for each sampling point Using the Graphs toolbar is possible The first graph is the daily average trend Ad Row 3 Col Print Print the Graph a Change the number of graph showed The number of Trend viewed is the same as the number of trend printer for each b A4 page 88 104 Nome File BioTrends 2 3 User Guide docx fe rc a lex BioTrends User Guide Environmental Monitoring Software System 7 3 3 2 GRAPH from Statistic In the Statistics tab click on i 3C01X2Row key to obtain the histograms of statistics showing the total number of samplings the average the number of samplings
130. ur gowning validation procedure is reached then close the cycle See close Gowning Validation Cycle 5 3 2 Closing a Gowning Validation Cycle To close the Gowning Validation cycle click on the Close the Cycle key in the sampling session x Department A S 0 P No OAs 00 a Sampling plan Sa mpling plan dA p owning Validation SM type of Control e amplings starting era Export 2 Audit Trail 7 Cancel Confirm by click on Yes if you want to really close the cycle Biotrends Ver 2 3 0001 NOTE If you click on Yes it is no more possible to go back and the validation cycle must be closed Personnel gowning validation Set the correct Date of Validation and Expiring Date and click on OK Key A message confirms that The Validation cycle is closed and rie saved Biotrends Ver 2 3 0001 Expiring date If a new Gowning validation starts for the same person the Test number will be set to 1 Figure 88A B C D Closing a Gowning Validation Cycle Nome File BioTrends 2 3 User Guide docx 65 104 Felc N lex BiolTrends User Guide Environmental Monitoring Software System 5 3 3 Gowning Validation List This function allows to view the full list of gowning validation performed expired in expiring To open the list of Gowning validation follow one of the methods below archilex BioTrends ver 2 3 Analysis and Trends View Admin Windows Help E Mail Schedu
131. ure media will be used for sampling and as an attribute to define the batch number used in microbiological sampling which will then be indicated when saving the data of the sampling sessions amp Insert or Edit Types of Media is Input of data gt Types of Media Field Description Type Description Figure 27 Insert or Edit Type of Media 4 2 2 10 Type of Devices These are the types of device used for sampling and sample analyses such as SAS for sampling air volumes Incubators for plates etc The types of Device constitute an attribute of Equipment The pieces of Device used will be specified on the sampling entry screens The records identified by a padlock are system records and are locked The records are not modifiable QI Types of Raw material a a sl E Types of Devices gt Status Active P 27 01 2012 13 58 T Number of terns 8 j Figure 28 Insert or Edit Type of Devices 4 2 2 11 Type of Body points The personnel is monitored by carrying out sampling on the points of the body and or on the accessories worn by operators e g right forearm left forearm right glove left glove etc To obtain significant trends it may be advisable to sort such points into categories For example it is not very useful to display a trend showing only the left glove It is much more likely that we will be more interested in displaying the trends of both gloves on the same graph In order to facilitate this typ
132. which Areas are subdivided Specific Bacteria Additional Info e g 5 days reading 10 days reading different dilution Devices Instruments used for sampling and laboratory activities Nome File BioTrends 2 3 User Guide docx BioTrends User Guide Environmental Monitoring Software System Menu Option Admin gt Lists gt Basic Admin gt Lists gt Basic Admin gt Lists gt Typology Admin gt Lists gt Typology Admin gt Lists gt Typology Admin gt Lists gt Typology Admin gt Lists gt Basic Admin gt Lists gt Typology Admin gt Lists gt Typology Admin gt Lists gt Typology Admin gt Lists gt Typology Admin gt Lists gt Typology Admin gt Lists gt Typology Admin gt Lists gt Typology Admin gt Lists gt Basic Admin gt Lists gt Basic Admin gt Lists gt Basic Admin gt Lists gt Basic Admin gt Lists gt Basic Admin gt Lists gt Basic 26 104 ferchil Data Description Temperatures SX Menu Option Admin gt Lists gt Basic Degrees range of incubation temperatures e g 20 24 Hours of Incubation e g 48 72 Standard Volumes Exposure Used for Air sampling e g 1000 cm 500 cm 4 hrs etc Sampling points Roles of the Personnel Admin gt Lists gt Basic Time Admin gt Lists gt Basic Admin gt Lists gt Points Admin gt Lists gt Personnel e g Laboratory Manager Analyst Maintainer Personnel Management Row Material Batches Product Batches Media Ba
133. wning amp Alarms environmental samplings amp Reports and Statistics amp List Deviation reports The Insert or Edit Deviation reports window is showed Complete all the data and click on Save Figure 92 Insert New Deviation Report window Nome File BioTrends 2 3 User Guide docx amp 2 Gowning validation Figure 91 New Deviation Report 2 Insert or Edit Deviation reports Input of data gt Deviation reports Nun Opening Date Closing Date Description Signature of Responsi Status 67 104 ferchilex 5 4 2 List of Deviation Report w archilex BioTrends ver 2 3 1 Click on the option Tasks gt List Deviation Report from the main menu New Samplings Gowning validation List Deviation reports E Signatures undo requests New Deviation report p Samplings amp Media 2 Click on List Deviation Report in the Quick access E samping sessions _ ame 82 i E Signatures undo requests 2011 339 Win d OW A Trends amp Exceeding Acceptance Limits a D Sampling Points Alert last thirty days 8 i Action last thirty days 3 Signatures undo requests to All 1 to Calda Andrea 1 _ i Samplings amp Media 7 Points to sample last thirty days 6 E Compressed Gas Media to Read last thirty days 6 fj Raw Materials Finished Products of Personnel Gowning Alarms environmental samplings FRR SSS List Deviation reports I FRc e
134. ws one of the methods below archilex BioTrends ver 2 3 A o File Analysis and Trends View Admin Windows Help E Mail 1 Click on the option Tasks gt Signature undo P Scheduler o requests from the main menu New Samplings g Gowning validation List Deviation reports Signatures undo requests 2 Click on the message in the status bar Info 42 Lock Time 59 59 I signatures undo requests 1 ll a e e e e e e e e e e e e d Info 2 Refresh a Updated 07 02 2012 12 02 24 3 Click on Signature Undo request in the Quick amp ISS 4 New Sampling session i Samplings Number access window i l New Deviation report 2012 82 off Samplings amp Media 2011 339 Sg Sei amp Exceeding Acceptance Limits r Signatures undo requests Alert last thirty days 8 rem ii gui colin rimase skih Chevy San mp 3 T D Sampling Points cars undo requests i Cisa Eit Area 1 Ta 1 F to Calda Andrea 1 ff Environment i z LAr 2 Samplings amp Media Surf Paints to sample last thirty days 6 ma i E Media to Read last thirty days 6 be ater ke B Compressed Gas pe Raw Materials so Finished Products i Personnel Gowning LO sy Alarms environmental samplings Reports and Statistics 1 IA Mich mi In the opened window select and click on the specific request Signatures undo requests Filte Filter res ae Add Change Print Ex Cancel Ok z Recording date me ds Samp
135. x days ago Validations canceled Active personnel open it shows the list of the open Validation tests that have not been finished yet the three foreseen tests have not been carried out Active personnel passed Active personnel failed Active personnel all Not active personnel all not active personnel are the people who are no longer employed in the company To modify the expiry date of a passed validation retertst couning vation select an element from the list and click on the Input of data option Change from the window menu the CIs E screen to modify data will be displayed change fto eeu eee e n Last name Name OMAN 5 Op Manutenzione OMAN 5 Op Manutenzione the date enter the reason and click on the Save Validation number 0 T Sampling Date 29 06 2009 29 06 2009 iri ate Byos210 o Si b u tto n oe ee Status Active Active Figure 90 Insert or Edit Gowning Validation Expiring Date Nome File BioTrends 2 3 User Guide docx 66 104 ferchilex 5 4 Deviation Report BioTrends User Guide Environmental Monitoring Software System To open a new Deviation it is necessary to define a new deviation report characterizing it by its number description opening date closing date status and the manager s signature Afterwards all the sampling operations that have caused its opening can be added to the file When the Deviation has completed its path it will be
136. y the RSS diro Es Print Labels key will setup parameters The page and 31 12 2013 00 00 00 the label dimension are in tenths of oa a botto 123Test a millimeter label no 201202100903441 label no 201202100903442 label no 201202100902443 display different A4 sheet 2970 x 2100 option box Follow Then click on Save to save the wig eres i i the description check change or Undo Change if you wp 31 122013000000 exp 3111220130000 or not the options lotto 123Test lotto 123Test and click OK A label no 201202100903444 label no 201202100903445 Preview window will be showed don t want to save the change Figure 119 Print Barcode functionality 96 104 Nome File BioTrends 2 3 User Guide docx fe rc a OX BioTrends User Guide Environmental Monitoring Software System 8 1 NewLabels Print template To create a new label template select a blank row and click on Edit Selected key In the editable field it is request to insert the following information e Title of template e Page width e Page Height e Page margin Top e Page margin Left e Page margin Right e Label Width e Label Height e Table Columns e Rows Space e Columns Space The value inserted must be in tenths of a millimeter Example for a A4 page the Page width value is 2100 and the Page Height is 2970 Nome File BioTrends 2 3 User Guide docx 97 104 fe rc a lex BioTrends User Gu

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