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Contents
1. 45 50 55 4 ance to these acceptance criteria provides documented evi dence of a device s operation within expectation of intended use Such compliance is required by law and is listed in the Code of Federal Regulations under headings Part 210 211 820 58 and 21 Part 11 as well as other such regulations and guidance as applies Forms may be used as built in records to store data as it occurs lending to use of the forms for tracking audit trails The forms are further useable as a basis for generating reports in a variety of formats However as reports are changed the underlying processes e g the forms containing the data from which the reports are generated stay the same Basic univer sal forms stay the same while the data they contain can be used to report in many different ways The forms may be provided to a user in a wizard type environment i e as a wizard type interface wherein the user is prompted for simple tasks the response to which are incorporated into a much larger data product In this way the user only has to deal with simple single item tasks one at a time Anenterprise content manager ECM may be employed to provide a secure platform to manage all data storage meta data extraction and archival of data One non limiting example of an ECM that may be employed is a Cerity ECM e g available from Agilent Technologies Inc Palo Alto Calif Since an ECM is an enterprise system it also pro2. Wda e ZOE v09 ouisuq Juv Zeue Nw EEG MORE uononpoy ssad0lg OST era peseg suuoq SWP I Jos 440 863 B2 US 7 Sheet 7 of 7 2008 Oct 21 U S Patent SULIOJ popueddy ym yoday CEL yodsy pereuiom y ZELL t e rg 3nduj LIEPEN oryde Zoom OEL edq po dajaqoiny CCL ewa enuen L OIL oor LA ISEW posieduy uode payewoyny TIG Ayug yenueyy JO swo J vil TIL ssooo1day ouiduq sao uonp n eo 1opu Auy Soupr duroo au uonoojqoiny eouer duio opt l L Old eSexoeq Tre erd qusuidinby JOpUSA Data r gt m98uuoo C OIL 2201 IXH 10 boren Ad OO OI 10 SULO f ve I 2soog ononusu 80L I 10 suo Xoaul wig 90L TOL US 7 440 863 B2 1 INTEGRATED TOOL FOR COMPLIANCE TESTING WITHIN AN ENTERPRISE CONTENT MANAGEMENT SYSTEM BACKGROUND OF THE INVENTION Qualification of instruments for regulated markets has tra ditionally followed one of two models paper based protocols that are run on instruments using the native controllers of the respective instruments and external calculations or qualifi cation routines that are embedded into the controlling soft wares of the instruments respectively Some efforts at auto mated data collection have required that an alternative data path be employed for the data collection while still control ling the instrume
3. a user can interac tively select an entry as in the case of Model Number 212 shown in FIG 2 where a drop down menu is provided from which the user can selected the proper entry or manually input an entry such as by typing cutting and pasting scan ning or some other alternative data entry mechanism that requires intervention on the part of the user Further alterna tively the user interface 250 may be optionally used to enter all data required by a form either as a result ofuser preference to do so or because an instrument being considered is suffi ciently old or unsophisticated so as to lack a sophisticated enough software interface to supply some or all of the data automatically by interfacing with the present system As another alternative a user interface may display a test protocol that prompts the user to input information regarding results ofa test In some instances the test may be automated wherein the system may prompt one or more lab instruments to initiate a test protocol in response to one or more answers inputted into the user interface by the user in response to questions asked on an interactive form test protocol or in response to results from another instrument e g in response to a test protocol designed for that instrument The system may also provide a report detailing processes and or instruments that do not comply with selected specifi cation De a protocol deviation form The forms may be XML based fo
4. allows flow charts to be readily modified interactively Such chart building soft wares provide a visual manifestation of a process imple mented and controlled by BPM 406 As a simple example if a current process flow of system 100 includes a process or subprocess defined by steps A gt gt B gt gt C gt gt but the current 0 an 5 20 40 45 65 10 user client requires step B to be performed after step A and before step C then the current process chart can be interac tively rearranged such as by dragging step C between steps A and B and dropping it there to result in a process subprocess defined by the steps A gt gt C gt gt B Accordingly the system 100 provides a great amount of flexibility for customizing the process control which is then managed by BPM 406 using forms based process management 604 as was described ear lier The technology neutral design of system 100 allows any client s or manufacturer s data system Oe Instrument s Data System 606 to be fed into ECM 404 Accordingly any type of instrument model of instrument or manufacturer ofan instrument may be included as instruments 612 from which data can be received by system 100 For example Instrument 1 may be a liquid chromatography gas chromatography instrument 612 produced by a first manufacturer Instrument 2 may be a liquid chromatography gas chromatography instrument 612 produced by a second manufacturer Instru ment 3 may be still anoth
5. are incorporated herein by reference to disclose and describe the methods and or materials in connection with which the publications are cited It must be noted that as used herein and in the appended claims the singular forms a and and the include plural referents unless the context clearly dictates otherwise Thus for example reference to a form includes a plurality of such forms and reference to the analytical instrument includes reference to one or more analytical instruments and equiva lents thereof known to those skilled in the art and so forth The publications discussed herein are provided solely for their disclosure prior to the filing date ofthe present applica tion Nothing herein is to be construed as an admission that the present invention is not entitled to antedate such publica tion by virtue of prior invention Further the dates of publi cation provided may be different from the actual publication dates which may need to be independently confirmed DEFINITIONS A platform as used herein refers to a support infrastruc ture for acceptance and coordination of tools and applications required to perform a series of related but diverse tasks An enterprise content manager refers to a system scal able to enterprise levels composed of various hardware and software elements that support the secure collection indexing and storage of electronic objects Disclosed herein are methods syste
6. described FIG 4 illustrates a flowchart of func tions and processes that may be managed by ECM 404 via business process manager BPM 406 BPM 406 manages flow so that data storage and format conversion to a technol ogy neutral format are carried out by ECM 404 at event 408 followed by reprocessing data reduction by data reduction engine at event 410 functions of which were described above Further calculations are carried out by calculation engine 306 atevent 412 which may be based upon instructions contained in forms 200 and the data populated into form 200 may be recorded and stored in ECM 404 at event 414 The record forms 200 may then be data mined at event 416 by record mining engine 440 to extract specific items of data metadata that are required to populate a final report FIG 5 illustrates data extraction from a form 200 to obtain information needed for preparing a report wherein a portion of a record form 200 is shown from which a particular data entry 502 is located Record mining engine 440 may employ toolsets for mining data e g name value pairs may be taken from forms 200 and calculation engine 306 may further extract those values needed by identifying such values based upon the names associated with the values in the name value pairs Data from a form 200 can be calculated and the result ing calculations may be returned to the same form 200 or to another form 200 as needed for purposes of organization readability clar
7. from the true spirit and scope of the invention In addition many modifications may be made to adapt a particular hard ware software instrument module process process step or steps to the objective spirit and scope of the present inven tion All such modifications are intended to be within the scope of the claims appended hereto That which is claimed is 1 A method of compliance testing at least one of instru mentation and software said method comprising the steps of converting data outputted from at least one analytical instrument or software to a technology neutral format which is independent of instrument type instrument model instrument manufacturer and data type of the analytical instrument or software from which the data was outputted and performing one or more calculations on the converted data to produce one or more outputs wherein said perform ing one or more calculations are performed according to instructions instantiated as forms selecting from said one or more outputs to populate a final report wherein the one or more outputs are standardized and are directly comparable to outputs resultant from said method carried out on another set of one or more other analytical instruments irrespective of manufac turer or model of the other analytical instruments and outputting at least one of at least one of said outputs and said final report 20 25 30 35 40 45 50 55 60 65 16 2 T
8. into technology neu trally formatted data metadata may be created by data reduc tion engine 302 of the system 100 so that algorithms from the instrument s 10 system s do not need to be relied upon and this further ensures standardization of results For example for application to chromatography the present system does not rely upon the software 12 running the chromatography instrument 10 from which the raw data is generated to deter mine what is a peak in the data or where to define the location of that peak as such determinations are made based upon calculations and algorithms run by the data reduction engine 302 of the present system Data reduction engine 302 reads the data having been converted into technology neutrally formatted data and converts this digital representation of an analog function into data representing features described characterized by the data e g peaks noise gradient steps etc The same applies to other calculations such as those determining and or filtering noise levels etc Using this approach consistent results are determined for data across the board whether a particular type of instrument 10 was manu factured by one or another particular manufacturer or whether the instrument 10 is a different model than another both of which data is being processed from As one example signal data from a chromatography instru ment 612 as inputted to system 100 by the native controlling software for the instr
9. mixed vendor modules as noted above Forms 200 that are driven by BPM 406 may be presented to a user by placement into a user specific inbox i e BPM Inbox 706 that functions similarly to the inbox of an e mail service In this way simple instructions can be provided in a wizard like environment i e where simple tasks are completed sequentially and interactively Thus ifa message is placed in inbox 706 that instructs a simple task to be performed once the task is performed or Done then the next task can be emailed or placed into inbox 706 At event 708 a user or manager assigning tasks to a user may choose the type of test or qualification to be performed In response to 20 25 30 35 40 45 50 55 60 65 12 this choice BPM 406 may then run a template to call the correct forms to be completed for the chosen test Configure stack 710 provides a configuration specific template which determines the required tests forms and instructions to be processed Forms for Instruction 712 are one option for pro cessing herein these forms 200 associated with a qualifica tion event may contain simple instructions for processing with no data entry potential Forms for Acquisition Process 714 provide another option for processing according to forms associated with a qualification event in which forms 200 may describe the setup of the native data system to perform spe cific runs and acquire specific data from
10. present system is referred to as Analytical Information Markup Language An IML which is an open source XML based standard for formatting analytical data By converting all data to a tech nology neutral format and then processing the converted data all according to the same protocols results are generated that are standardized and directly comparable among results for different instruments which may be different models and or made by different manufacturers As noted the computerized data system CDS that is in place for operating the instrument s to obtain the data on which a report is to be generated may be used as direct input to thesystem Thus original data collected for a report may be accomplished using the native controlling software of the CDS of the instrument s without the need to go through external analog to digital conversion or other manipulation Original data which may be preserved for possible reanalysis by the native CDS is also converted to an accepted technol US 7 440 863 B2 5 ogy neutral format allowing the data to be submitted to a single reprocess and calculation engine for consistent reduc tion and processing By using the native CDS the present system may also make use of the drivers employed by the native CDS thereby further facilitating the universal appli cability of the present system to different types of instruments and to instruments having different standards CDS s as a result of being
11. produced by different manufacturers Instructions may be instantiated as forms 200 e g see FIG 2 to provide procedural information while also func tioning as data repositories Forms 200 may be constructed in many different ways and presented to have as many different appearances some of which are dictated by the information to be displayed stored and much of which may be flexibly designed The instrument process type as well as the required input to the form 200 dictates the content and appearance of form 200 FIG 2 shows one example of a form 200 which is in no way meant to be limiting as many different forms may be provided by the system In FIG 2 form 200 includes fields instructing the following data to be inserted and stored Instrument Name 202 Other Name 204 Channel Descrip tion Split Splitless 206 Purged Packed 208 Volatiles Inlet 210 Model Number 212 Serial Number 214 and License Certificate ID 216 Forms 200 may be run as an applications program interface API and as such need not ever be even visualized by a user of the system when all data fields can be automatically identified from the technology neutral format ted data and or native CDS and populated into form 200 to complete all data fields Alternatively or additionally a user interface 250 may be provided to display one or more forms In a case where automatic population of all required data is not possible user interface 250 can display form 200 so that
12. readable form the data may be added to the forms manually and included into qualification processing with any required calculations and both the pro prietary data and the converted technology neutral data may be saved in ECM 404 The technology neutral formatted data can then be further processed by data reduction engine 302 calculation engine 306 and reporting engine 608 Reporting engine 608 requires at least one of a data mining application e g record mining engine 440 or a middleware component configured to pro vide an input file to reporting engine 608 to correctly populate a report Once final report 444 has been generated BPM 406 can direct reviews and signatures electronically at event 610 The final report both signed and unsigned may be stored in ECM 404 Further all intermediate forms 200 and the data that they store may be stored in ECM 404 to maintain a complete audit trail as was also discussed All processing represented in FIG 6 may be based on forms and the instructions contained therein WYSIWYG authoring capability may be provided by the forms designer application for designing forms 200 Secure data handling is ensured by ECM 404 Standardized US 7 440 863 B2 11 results are the end product of these methods providing a clear differentiator over anything that is currently available in the market The data path that the instrument 612 uses is the same data path that system 100 uses for reports such as co
13. report based on the data as opposed to the current need to create a method for each instrument that employs a different data type or format Thus calculation engine 306 can perform calcula US 7 440 863 B2 7 tions based upon a single library 304 e g series of calcula tions tailored to a specific type of report for a particular type of data reporting That is since consistent raw data sets 1 e technology neutrally formatted data are received by data reduction engine 302 these data set can be properly manipu lated with a single consistent method Thus although the method for acquisition of data may vary depending upon the computer data system from which the data is being acquired once that data has been converted to a technology neutral format the back end processing is consistent e g processing by data reduction and calculation engines etc Library 304 typically contains a set of calculations for performance ofthe standardized tasks in the back end processing e g calcula tion identification of peaks calculation of statistics describ ing the data etc With respect to data reduction and calcu lation the results may be standardized and independent ofthe originating data system or controlled instrument as noted above Reports based on those results are fully customizable as reports ranging from simple summary reports to tradi tional fully described compliance protocols may be output ted The library can be mo
14. the instrument and or software to be qualified Those same forms 200 may provide controls for entry which may be manual and or automated ofthe results obtained from the processes run with respect to the native computer data system to obtain the specific data Forms for Manual Entry 716 are forms 200 in which manual entry may be made directly to Alternatively entry may be made to these forms 200 via an application supplied user interface when required by a system being tested Manual data 718 refers to a further embodiment of forms 200 that may be created such that form elements are present to allow manual interactive entry of data from an attendant user Forms 100 may also be constructed as a mixed model where some elements of the forms 200 are automatically filled in when the data is available to the system When data is not available to the system for automatically filling in the forms 200 such data can be interactively filled in manually by a user Compliance auto detection engine 720 may be an applet very similar to calculation engine 306 that stores or accesses identifying characteristics regarding various types manufac turers etc of equipment So for example where a form requests a model number and serial number of an instrument 612 rather than requiring a user to manually enter this infor mation autodetection engine 720 queries the software 704 associated with the piece of equipment 612 to obtain the required information and
15. then automatically enters it into the form 200 from which the request originated If autodetection engine 720 is unsuccessful in automatically retrieving some of all of the information that was queried for system 100 leaves the entries for this information on the applicable forms 200 blank and presents the forms for manual completion in addition to the automatic generation autodetected data 722 to whatever extent was possible Data storage and format conversion ofthe inputted data are performed by ECM 404 as controlled by BPM 406 in accor dance with the instructions contained in forms 200 selected by BPM 406 for processing the data wherein forms 200 identify the particular data that is needed In this example data is converted to AnIML formatting 724 or other common data form CDF such as AIA Analytical Instrument Asso ciation or ANDI Analytical Data Interchange format typi cally annotated with cdf extensions using Native Data ANIML package 726 Once converted to technology neutral format data reduc tion engine 302 which is also tightly integrated to ECM 404 may perform reprocessing of the data in accordance with the needs of the final report to be generated as instructed by the forms 200 that need to be filled out and as guided by BPM 406 Reprocessing data reduction calculations can be can be driven by API so that no user interface is required De No GUI Reprocess 728 Thus data can be inputted directly from an instrum
16. trail based upon forms and data stored in the data base 11 The method of claim 1 further comprising identifying the hardware from which data to be converted was outputted from based upon the rules based algorithm associated with the form 12 The method of claim 1 wherein said calculations are performed to answer a series of questions relating to one or more performance tests designed to determine compliance of the analytical instrument or software under consideration with a set of predefined criteria 13 The method of claim 12 wherein the set of predefined criteria comprise criteria defined for regulated industries 14 The method of claim 13 wherein said predefined cri teria comprise regulations set forth in the Food Drug and Cosmetic Act 15 The method of claim 1 further comprising automati cally storing results of one or more of the calculations on the forms 16 The method of claim 15 further comprising manually inputting information on the forms 17 The method of claim 16 wherein said manually input ting is performed interactively through a user interface 18 The method of claim 1 wherein said performing one or more calculations comprises creating a technology indepen dent reduced metadata set from said technology neutral data 19 The method of claim 18 further comprising correlating the metadata into a cohesive audit ready report that follows best practices for compliance documentation 20 A method of com
17. 06 01 GOIP 21 00 2006 01 dent of instrument type instrument model instrument manu GOIR 35 00 200 6 0 facturer and data type ofthe analytical instrument or software 01 from which the data was outputted Calculations are per 52 U S Chren ee 702 108 formed on the converted data to produce one or more outputs 58 Field of Classification Search 702 108 and then selection is made from the one or more outputs to M 702 182 189 populate a final report wherein the one or more outputs are See application file for complete search history standardized and are directly comparable to outputs resultant rom carrying out the method on another set of one or more 56 References Cited ae er Muri em SE eee of U S PATENT DOCUMENTS manufacturer or model of the other analytical instruments 5 961 448 A 10 1999 Swenson etal 600 301 and or software 6 456 955 Bl 9 2002 Andrews et al 6 978 218 B1 12 2005 Kolbetal 702 122 33 Claims 7 Drawing Sheets Input Data in Native Format 110 Perform Data Reduction based on Technology Neutral 7125 L Formatted Data 3 Convert Data to Technology Neutral Format 120 Perform Calculations 130 Output Standardized Results 140 U S Patent Oct 21 2008 Sheet 1 of 7 US 7 440 863 B2 Input Data in Native Format Convert Data to Technology Neutral Format 110 120 D Perform Data Reduction based on Technology
18. Neutral r 125 L Formatted Data J U Perform Calculations Output Standardized Results 150 140 FIG 1 US 7 440 863 B2 Sheet 2 of 7 Oct 21 2008 U S Patent C Old OSC 9l6 88s0LSPCC OT INIMII 3su or cil 00 jeemeew OLS ya u s nejoA O 80C poyoeg padingO 906 ss nrds 1ids O We x eec ro J gue 3ureN 3ueuinisu ouutq 1sJ1 pue urojs g e1ouor US 7 440 863 B2 Sheet 3 of 7 Oct 21 2008 U S Patent DIA s NsoY poziprepuejg 80 001 A ouisuq uone no e 90 ourdu q uononpoy eq COL s SQO SG Wm ns Ol U S Patent Oct 21 2008 Sheet 4 of 7 US 7 440 863 B2 100 404 406 Data Storage and Format Conversion l Extract Using Mining Engine y Automated Report Generator Calculation Engine Customizable Report FIG 4 US 7 440 863 B2 Sheet 5 of 7 Oct 21 2008 U S Patent DI 0c TOS GOMAIOOLAOLL Qu umnsur sorreu2 o TL T TIdO L S0681 TYL 01 JeInsay qadlaeuAW 0 Lgoumoss H0 8 8 8 T INDOONA XIN f ure ns lt lt 0 0 0 0 010 0 G O 0 r xineW T 24 ALAASOJX ADIGA 2d qns 1xoy 4Cq4 95901d 0 0 1e n8o3 044 peuA A 100 221nos2 00160 01 Z0 8 8 0 0 0 0 xogg efqox edAq g11 3u y gt gt fq0 0181 10fqepueq lt lt adA T od amp qns s 3eqsurcpdez uo 49seg q Z 2ur ao dad 1 fqo 0 S1 1efqepusormu qoo p1 elqouado lt lt q oweu 3usumnsur 0 uuo
19. Thus forms 200 can be interactively filled out by auserthrough user interface 250 and or can be programmati cally filled out by autodetection processes or calculation engines Various combinations of forms 200 automation and cus tom reporting may constitute a final report by system 100 For example forms 200 alone may be interactively filled out by a user to prepare a final report Using ECM 404 together with forms 200 forms 200 along with the final report 444 may be centrally stored and provide an audit trail for support of the final product By adding the automated calculation engines such as data reduction engine 302 calculation engine 306 and records mining engine 440 for example processing may be fully automated to provide a final report if only according to a defaulted form ofthe final report 444 Adding the autodou mentation application 442 provides further flexibility whereby a final report 444 can be customized Note also that the modules need not be combined as described or in the order as described For example forms 200 may be combined only with automated report application 442 so that a final report 444 generated from manual inputs to forms 200 may be customized using the automated report application 442 Further a hierarchy of forms 200 may be provided for more efficient completion of forms 200 during processing For example a master form may be set up to feed other process forms A master form generally contains in
20. United States Patent US007440863B2 12 10 Patent No US 7 440 863 B2 Manfredi 45 Date of Patent Oct 21 2008 54 INTEGRATED TOOL FOR COMPLIANCE 2003 0084340 Al 5 2003 Schertz etal 713 201 TESTING WITHIN AN ENTERPRISE 2004 0109453 Al 6 2004 Wirth 370 393 CONTENT MANAGEMENT SYSTEM 2004 0128646 A1 7 2004 Jindal et al 717 102 2004 0145598 A1 7 2004 Parent etal 345 698 75 i 2006 0041840 A1 2 2006 Blairetal 715 513 75 Inventor Charles Manfredi Oahurst NJ US 2006 0077895 Al 4 2006 Wright 370 235 73 Assignee Agilent Technologies Inc Santa Clara 2006 0247885 Al 11 2006 Manfredi 702 120 CA US OTHER PUBLICATIONS Notice Subject to any disclaimer the term of this Webopedia metadata 2 pages 2007 1 patent is extended or adjusted under 35 IEEE Xplore Standardization of data ow for laboratory automation U S C 154 b by 35 days soft on XML technology 2 pages 2006 cited by examiner 21 Appl No 11 119 255 Primary Examiner Michael P Nghiem 22 Filed Apr 29 2005 57 ABSTRACT 65 Prior Publication Data Methods tools systems and computer readable media for US 2006 0247878 A1 Nov 2 2006 compliance testing instrumentation and or software Data 5 I 1 from one or more analytical instruments and or software is 5 Int Cl converted to a technology neutral format which is indepen G01M 19 00 20
21. also be provided for calculation engine 306 to allow a user to use it as a custom calculator for example so that the same results can be manu ally calculated through interface with a user since the cus tom calculator uses the same engine 306 that the automated client uses Any or all of the manual data 718 autodetected data 722 and metadata 730 may require some additional manual entry ies depending upon the particular instrument from which data is being obtained Examples of metadata entries that may need to be entered manually include but are not limited to results of data collected from a source other than the data source provided by the native CDS such as readings from onboard sensors readings from external measurement devices etc Forms 200 that contain the manual data 718 autodetected data 722 and metadata 730 are mined for the specific data required by the final report 444 to be created such as by using record mining engine 440 and the mined data may be forwarded to an automated report generator application 442 that assembles the mined data into an auto mated report input file 732 which is forwarded to an unparsed master file 734 from which the automated report application renders the final document 440 Alternatively an automated report application need not be implemented For example final reports may be embodied by completed forms 200 without the need to data mine such forms Further alternatively a final report may b
22. as well as from different manufacturers to compile reports thereon It would be further desirable that such a solution provides standard ization among various data types so that one platform can be readily used to generate reports using data generated from instrument having different platforms and or still other instruments that aren t included with any established plat forms Accordingly there is a need for solutions that are generally applicable for use with data generated collected by instruments from most if not all manufacturers to readily prepare reports therefrom and or otherwise manipulate the data as needed SUMMARY OF THE INVENTION Methods tools systems and computer readable media for compliance testing of analytical information are provided Data outputted from at least one analytical instrument and or software may be converted to a technology neutral format which is independent of instrument type instrument model instrument manufacturer and data type of the analytical instrument from which the data was outputted One or more calculations are then carried out on the converted data to produce one or more outputs and selection from the one or more outputs is made to populate a final report The one or more outputs are standardized and are directly comparable to outputs resultant from the method being carried out on data a 5 35 40 45 55 65 2 from another set of one or more other analytical instrumen
23. ate a final report wherein the one or more outputs are standardized and are directly comparable to outputs resultant from said method carried out on another set of one or more other instruments and or software irrespective of manufacturer or model of the other analytical instruments 22 A system for standardizing characterizations of at least one of analytical hardware and controlling software during compliance testing said system comprising algorithms for converting data from a native format as outputted by an analytical or other instrument to a tech nology neutral format a data reduction engine configured to reduce said data to a technology independent reduced metadata set a calculation engine configured to perform at least one calculation on at least one of said data converted to a technology neutral format and said reduced metadata set to produce one or more outputs required for a set of predefined criteria wherein said one or more outputs are produced to answer one or more questions relating to one or more performance tests designed to determine compliance of the at least one of analytical instrument and software under consideration with said set of pre defined criteria and a user interface for displaying said outputs thereon 23 The system of claim 22 further comprising an auto matic detection engin0e configured to determine at least one ofinstrument and controlling software specific information to automatically cha
24. dified typically added to to increase functionality but it does not have to be a different library basedon the data system that the instrument used contrary to what is currently required Consequently calls become con sistent and calculations become reusable and portable For example a library may be created to calculate peak precision signal to noise etc and library 304 may be built to accept only consistent input forms because the input format will always be the same since the engine for extracting data data reduction engine 302 will always be the same Running processes in this way provides consistent metrics across all manufacturers types and models of instrumentation For example peak detection and baseline evaluation can be per formed as de facto standards against which all systems in struments may be evaluated Thus such a library 304 is reus able and portable being applicable to calculation of the defined data specifications based upon data inputted from the data reduction engine 302 and wherein data reduction engine 302 may beappliedto data from any applicable instrument for which it makes sense to calculate the prescribed specifica tions since the data from the instrument will have been con verted to a technology neutral format that the data reduction engine 302 is configured to receive as input The standardization of processing will advantageously reduce training requirements for operating personnel since personn
25. e compiled by mined data that is simply assembled and attached to the forms 200 containing metadata Everything between the raw data e g original data received from an instrument or instru mentation software and the final reported values is consid ered metadata Metadata may be raw data or mined data or a combination thereof as it is used to populate a form Some pre final data may already be provided on a form while addi tional pre final data may need to be added by the process The data on the forms 200 can all be considered metadata in the sense that it is used to create the final report data so it qualifies as data about the final report data BPM 406 may then forward the final document such as via e mail for example to have the final document which may be in pdf format as in the example shown in FIG 7 signed The final report cannot be modified by those reviewing it but must be reprocessed by the system 100 if changes are to be made The process flow for such a rerun or re evaluation involves returning the process to the step that begins process ing the information that is desired to be re evaluated How 20 25 30 35 40 45 50 55 60 65 14 ever ifthis is not done then any changes will still be captured by ECM 404 through its automatic audit trails functionality Further BPM 406 together with ECM 404 may track the review process and store records of the same to maintain the chain ofthe audit tra
26. el will no longer need to be trained for operating with regard to each different piece of equipment but can instead be trained to run the standardized processes For example under conditions prior to the present invention it would not be unusual for an instrument piece of hardware 10 to be oper ating in various locations under multiple e g three different proprietary operating software platforms For compliance purposes it might then be necessary to replicate the compli ance procedures as many times as there are multiple plat forms By providing the present system as built on an inde pendent platform it is not dependent upon the operating software of the particular instrument upon which reports are to be generated In this way the system is readily adaptable to new various hardwares as well as softwares given the generic nature of the protocols As noted system 100 may further employ a calculation engine 306 to perform calculations on the reduced metadata set produced by data reduction engine 302 for formulating standardized results 308 Calculation engine 306 performs calculations on metadata in the reduced metadata set received from data reduction engine 302 as well as any calculations 20 25 30 35 40 45 50 55 60 65 8 that may need to be performed on other data that has been converted to the technology neutral format as instructed by forms 200 such as for the performance of qualification ser vice
27. ent s operating software 704 to instrument 100 where it may be converted to a technology neutral format and then fed directly to data reduction engine 302 US 7 440 863 B2 13 The reduced reprocessed data is forwarded to calculation engine 306 in this example calculations are performed for a compliance report and engine 306 is referred to as a compli ance engine for further calculations that are instructed by forms 200 Calculation engine 306 may mine forms 200 that have been populated by the reprocessing by data reduction engine 302 or may obtain data from mining results based on matching names to name value pairs as described above perform the instructed calculations and together with the reprocessed data output metadata 730 which is chromato graphic metadata in this example This processing may also be API driven so that all processing may be carried out in the background without interrupting a user for interactive input However even if all the automation cannot work as intended such as when an instrument lacks adequate soft ware or other capability for automatically interacting with system 100 for example then system 100 may launch user interface 250 to accept some interactive input from a user under guidance of a standard operating procedure so that the user can interactively choose information to be filled in Even the calculation engine 306 is designed to work as an API as noted However a user interface 250 may
28. er liquid chromatography gas chro matography instrument 612 produced by a third manufac turer Instrument 4 may bea mixed vendor system Instrument 5 may be a refrigerator with an embedded microprocessor or other associated hardware software configured to input data to system 100 or alternatively data from this instrument may be manually inputted via interface 250 if Instrument 5 is not sufficiently automated and Instrument 6 may be a centri fuge wherein the same considerations apply as described with regard to Instrument 5 A mixed vendor system refers to systems produced by more that one manufacturer vendor Examples of mixed vendor systems include but are not lim ited to acomputer data system manufactured by a first vendor and controlling an instrument manufactured by a second ven dor a computer data system produced by a first vendor that controls instruments produced by second third and fourth different vendors or a computer data system produced by a first vendor and controlling a single instrument made up of components produced by different vendors etc As long as the associated computer data system can successfully drive the mixed vendor system the present system can process the data in a manner as described As noted above if the instrument s data is proprietary data the proprietary data is converted to technology neutral for matted data e g AnIML using data system control API s 602 or if provided in human
29. formation that is globally the same with respect to all process forms that it feeds Accordingly this permits that global information to be filled out only once after which is automatically appears in all of the subordinate forms 200 fed by that master form 200 Different types of master forms 200 may also be created For example a qualification master form 200 may contain global information such as customer information address names etc instruments that a qualification will be covering and or acceptance limits for instrument categories n instrument configuration master form 200 may contain a named configu ration mapped t configuration details e g a stack of instru ments 612 and or override limits for specific equipment US 7 440 863 B2 15 needs A stack for example may include all of one type of instrument different vendors instruments or any combina tion of instruments as the complexity of the stack can be programmed into an instrument configuration master form 200 Instrument configuration master forms 200 may be lim ited to only those instruments and vendors that are configu ration master approved to prevent a user from arbitrarily attempting to add an instrument to an instrument configura tion master form for which there is no procedure for process ing Using the methods and systems described herein non vendor specific instrument qualifications may be processed using a native controlling software of an i
30. gqnsy 9 juo v LL lt 3JA PI9 4 IXOLINL 00 01 1epso3 0o1gpeuAN Lv G A O I nereqionns y 0911 G L v4v Gusumnnsu sarreure oro owen 3usumnsu JAq 1 4 0 6 dA93prj sdAqns x T LAAZEOr Up LET g8cassrx6z cocce Lcv SOOTSE 1 1c hoou d q 8S 1u oreqnouuy d jp J 22fqo 0 6p0 3opu l 0 0 1oustso q auto oqopy 101e219 00 p0 PS T T6 TOTEOOZ CD91equone215 00 50 69 61 1G 1600 0 9 TPPOYW fqo oni PIJIEW IDGJ TJENA 2 LUT 8Jepe q q d q woysarpionnys lt lt y G 001 dpx dpx yg O g6 12So e2o s e du q 0 ze Syuooyy q oe dpx dpx v A4x 8 a LL 0 I9W OVQ 3 A 0S 1e nSosr Idle uA A 3 0 SIT juo 4 2 O LT SPISTd 29uue gonny AA O gg seureN So ee5 S dA Ly O z soBeg 291 Qe 0 Tofqopuspueanspuo Oo y o pizpoqox S lt lt 8 1 1 xepuj ut 0 103 NIJo 3 X 2dAL OC I A v 1 10121p21q p suum oS gt gt suued pooS q opo53 C l8 4 1 ILd l suo q ge cL MIOPP 960686PPCEPL6UISO9E 1 gt lt 2S00APHSBSOORELELPLSES T 880968 GI 3 0 I LOO 6IT 9Z15 7 qe O ATI ewop no WDN lu uunj33su eqopy 1eonpoid 0 0 1fqepuoq q 96 sieseiep y d v6 qGqv Z I G LP I9H US 7 440 863 B2 Sheet 6 of 7 Oct 21 2008 U S Patent 9 DIJ 9 ju umnsul yu oumnsu 019 BISd pue MIAM Paq Wd 909 wa sA Byeq sjuoumsu p 1uoumusu yu umnsu C uoumnsul eurdug Surodos 3uoumusu 90 709 ouisuq Suylodsy SIdV Ionuoo uone no e uiojs S eA 90
31. he method of claim 1 further comprising inputting the data to be converted from a native controlling software of the analytical instrument from which data is to be converted 3 The method of claim 1 wherein said performing one or more calculations comprises data reduction said data reduc tion being carried out by a data reduction engine wherein the same data reduction engine may be used for data received from multiple analytical instruments 4 The method of claim 3 further comprising inputting results of said data reduction to a calculation engine and performing at least one further calculation based upon said inputted results 5 The method of claim 1 wherein said forms contain data generated from at least one of interactive manual input infor mation detected by a system performing said method and software of system a computerized data system of an instru ment from which data is being converted and calculated reduced data 6 The method of claim 1 wherein said forms include launch points for executables that perform functions per formed by said method 7 The method of claim 1 further comprising storing said outputs of performed calculations on the forms 8 The method of claim 7 wherein said selecting comprises selecting outputs from said forms 9 The method of claim 7 further comprising storing said forms in a database as a repository of processed data 10 The method of claim 9 further comprising identifying an audit
32. il The final report 440 is thus a defensible piece for use in meeting compliance regulations Forms 200 provide the basis for processing data by system 100 Wizard like central data collection may be provided wherein either the automated client or a user are provided with simple tasks to complete by filling in the appropriate data which may require a user to type in scan in select or otherwise enter data or which may require the automated client to query the instrument s software for the data which is then inputted to the form orto perform calculations on select technology neutral data having been converted from the native data received from the software of the instrument or other processing as instructed by the particular task presented by the form In their most basic configuration forms 200 are provided to generate a customer deliverable typically a final report containing specifically requested or required data Thus forms 200 with standard defaults may be provided to automatically generate such a final report Further forms 200 stored in ECM 404 may be configured to function to provide an audit trail such as by storing ver sions of the forms as they are completed together with data and time stamp for example Further forms 200 may be configured to contain instructions for all processing by sys tem 100 For example certain forms 200 may contain specific instructions for calculations to be performed by calculation engine 306
33. ity etc As shown forms 200 actually do contain the information data received from the software of the instrument being con sidered and that data can be mined to fill out automated report applications or otherwise to fill out a final report 444 In this way forms 200 act as a repository that can be mined in various ways compliance asset management etc Once a final report 444 is signed however the data that was mined to fill out the final report document 444 can no longer be changed ensuring inviolable metadata so that an effective audit trail is maintained An automated report application automated report genera tor 442 may be optionally included and if used functions to automatically populate documents at event 418 which are US 7 440 863 B2 9 then outputted as a customizable report 444 at event 420 Automated report generator 442 is an application that facili tates that construction of configuration specific documents from a library of all possible configurations Automated report generator 442 allows documents to be populated with content learned through many various mechanisms such as the mechanism that have populated forms 200 An analogy to one function of the automate report application 442 is with reference to an automobile and an automobile user s manual that accompanies the automobile Because the owner will typically have many options from which to choose from the owner s manual is typically written to de
34. mpliance However the calculations performed on the data for whatever report is to be produced do not need to be performed on the instrument itself nor does the instrument s software need to be employed for performing calculations Advantageously system 100 provides everything that is needed for performing such calculations This effectively reduces the native com puter data system CDS to a controller and data acquirer Such reduction provides checks on the interplay between the hardware and software of a system to be qualified at each qualification event without burdening the hardware qualifi cation event with data reduction evaluation of the native CDS This assures that the more frequent requirements for hard ware qualification provide the maximum value with respect to CDS verification without forcing extensive CDS evaluation Further the controlling system CDS need not be qualified for use in the qualifying of hardware since it is not used for such purpose by system 100 Rather system 100 performs calculations on the raw data produced by the instrument after conversion to a technology neutral format if necessary thereby taking the instrument s controlling software out of the loop and effectively separating the instrument s hardware from the associated software so that the report can focus on the hardware independent of qualify the instrument s con trolling software The modularity provided by system 100 facilitates m
35. ms and computer read able media for processing data outputted by analytical instru ments in a standardized manner so that results of processing are directly comparable with results from processing data outputted by other instruments regardless of model or manu facturer Methods tools and computer readable media for generating transmitting and storing forms specific for a user s needs are provided including but not limited to com pliance validation forms Systems include computers and associated hardware that may be connectable to a network for internet or intranet use that can execute rules for a selected form e g one non limiting example is a form suit able for submission to a regulatory agency such as the FDA In one embodiment a system is provided to perform analyti cal hardware qualifications Calculations may be performed to answer a series of ques tions relating to one or more performance tests designed to determine compliance of an analytical instrument and or soft ware under consideration with a set of predefined criteria Such predefined criteria may be criteria defined for regulated industries For example predefined criteria include but are not limited to regulations set forth in the Food Drug and Cosmetic Act Predefined criteria are limits and criteria that represent best practices and manufacturers specifications relating to instrument operation and performance Compli 0 Di 5 25 35 40
36. nstrument com bined with a technology neutral standardized post collec tion data reduction and reporting model Such processes may be provided by universally applicable scalable automated secure and consistent platform for the development and delivery of instrument qualification Original data collected for the qualification may be accomplished using the native controlling software without the need to go through external analog to digital conversion or other manipulation However the system 100 is not precluded from using alternative data input methods including but not limited to data that has already been digitized manual input of data etc Original data may be preserved for possible reanalysis by the native controlling software and may also be converted to an accepted technology neutral format allowing the data to be submitted to a single reprocess and calculation engine for consistent reduction and processing Instructions may be instantiated as forms which may provide procedural infor mation as well as act as data repositories Forms may be presented according to need and apply only to the instrument under test to reduce delivery complexity and error while providing audit trails for tracking While the present invention has been described with refer ence to the specific embodiments thereof it should be under stood by those skilled in the art that various changes may be made and equivalents may be substituted without departing
37. nt suing its native controller Examples of proprietary embedded software suites include Cerity NDS Agilent Technologies Inc Palo Alto Calif for chemical pharmaceutical quality assurance and quality control and Empower CDS based on Waters Millenium software Waters Inc Milford Mass These software suites are limited to the suite of instruments that they can control Thus even though these suites are proficient for producing data and results for qualification quality assurance tasks for the particular instruments that they control such suites cannot provide standardization of the data types that are processed nor calculations across controller platforms Further data is maintained in a proprietary format that requires the collecting data system to be present and functioning for viewing and reprocessing any data used outputted by these systems Recently an integrated single source of data collection and storage was introduced by Scientific Software e g EZChrom Elite While offering a relatively large driver set this solution is still limited by the available drivers that are provided with the solution Further all of the current solutions including those men tioned above as applied to instrument qualification require decoupling of the native system that controls the instrument to be qualified in one fashion or another It would be desirable to provide a solution capable of incorporating data from different instruments
38. ntation feature 442 may be optionally provided as noted above whereby the user is provided with selectable choices via user interface 250 to determine the format of the report 444 to be produced Thus depending upon the selection made different groupings of metadata from the underlying forms 200 are selected and combined into a format of the final form selected Audit trails may be automatically provided by the metadata stored as forms 200 by ECM 404 as alluded to above Further BPM 406 may provide e mail notification scheduling and review electronic signature functions etc Referring now to FIG 6 a flow chart that further explains process flow by the system is shown As noted above a user interface may or may not be needed which may depend upon the choice of the user the types of instruments being reported upon and or whether the system is capable of fully automati cally obtaining all information required to generate a final report System control API s 602 are provided for running processes so that there is not a need to display the process on user interface 250 The business process manager BPM permits flexible formatting of process For example the pro cess can be changed just by changing rearranging a flow chart similar to that which is shown in FIG 6 For example flow charts used may be flow charts produced by Microsoft Visio Microsoft Corporation Redmond Washington or other alternative chart building software that
39. odu lar instrument qualification after repair The process flow manager 406 may present forms specific to the tests associ ated with the requalification of a module The resultant data can be associated with the module stack and existing com pliance documentation to requalify the module Thus if a module needs to be repaired then that module can be requali fied rather than having to requalify the entire system i e qualification may be done on a modular basis BPM 406 may control the workflow from collection of data through approvals signatures of final report 444 and may be tightly integrated into ECM 404 The entirety of processing may be web browser based or terminal servers based so that no footprint is imposed upon the user s qualified computer In instances where ECM 404 has been incorporated into a cus tomer s system local interfaces e g user interface 250 may be employed Referring now to FIG 7 a more specific schematic repre sentation of system 100 is shown for use in creating a com pliance report for chromatographic instrumentation System 100 is represented as interfacing 702 with native CDS to receive data inputs In this example the equipment being reported on is mixed vendor equipment 612 in which case any or all of the vendor s computer data systems 704 may be employed through which data is inputted to system 100 Typically however a common data system controller CDS is provided to control all of the
40. pliance testing at least one of analyti cal instrumentation and software for analytical instrumenta tion said method comprising the steps of displaying a test protocol on a user interface and prompting a user to input information regarding results of a test prompting at least one analytical instrument or software associated with an analytical instrument to initiate the test protocol in response to an input by the user into the test protocol displayed on the user interface or results US 7 440 863 B2 17 from another analytical instrument in response to a test protocol run on the another analytical instrument automatically calculating results of the test protocol run on the at least one analytical instrument wherein said auto matically calculating step comprises converting data outputted from the at least one analytical instrument or software associated with an analytical instrument to a technology neutral format which is independent of instrument type instrument model instrument manu facturer and data type of the analytical instrument or software from which the data was outputted and per forming one or more calculations on the converted data to produce one or more outputs and performing at least one of storing the calculated results for later use in an output report and outputting the calculated results to the user interface 21 The method of claim 20 further comprising selecting from said one or more outputs to popul
41. racterize said at least one of said instrument and said controlling software 24 The system of claim 23 wherein said automatic detec tion engine automatically performs at least one of identifica tion of said instrument or software and extraction of perfor mance data from said instrument or software 20 25 30 35 40 45 50 18 25 The system of claim 22 further comprising interactive forms providing procedural information including calcula tion instructions and wherein said one or more outputs are stored on said forms 26 The system of claim 25 further comprising means for mining said forms to extract metadata needed to produce a final report 27 The system of claim 26 further comprising means for compiling the extracted metadata into the final report 28 The system of claim 25 further comprising a user interface configured to facilitate manual input to at least one of said interactive forms by a user 29 The system of claim 22 further comprising an enter prise content manager configured to provide a secure plat form and to manage data storage data conversion metadata extraction and archival of data 30 The system of claim 29 further comprising a business process manager configured to provide at least one of e mail notification scheduling and review and electronic signature functions regarding at least one of said forms and said final reports 31 The system of claim 22 wherein said system accept
42. rms that can be directly rendered to a final report such as in pdf format or other format suitable for paper documents for example Thus for example forms 200 may be displayed in pdf or some other document format on user interface 250 when part or all of them are to be interactively filled out by a user As noted part or all of forms 200 may be programmatically filled out from auto detection of calculation engines provided by the system Forms 200 may be left in native XML format and thereby function as storage for the data that they contain Forms 200 un 0 a 5 20 25 40 45 50 55 6 may be further rendered from the XML format to an HTML version for use with a browser When used interactively forms may be presented to a user according to need and thus forms that apply only to the instrument s under test are presented thereby reducing delivery complexity and error potential while at the same time providing audit trails for tracking since the forms may be saved as noted above By converting proprietary data into standardized data i e data having a technology neutral for mat the system may provide data in a standardized output form Thus inconsistent output from instruments can be con verted to consistent input to an engine that can do calculations in a very predictable standardized way which is an important consideration for qualification and compliance reports Once native data has been converted
43. s and features of the invention will become apparent to those persons skilled in the art upon reading the details of the system tools methods and com puter readable media as more fully described below BRIEF DESCRIPTION OF THE DRAWINGS FIG 1 shows a flowchart of events that may be carried out during processing according to at least one embodiment of the present invention FIG 2 illustrates one example of a form that may be used by an embodiment of the present invention FIG 3 is a schematic flow chart illustrating process flow according to an embodiment of the present invention FIG 4 is a block diagram illustrating functions and pro cesses that may be managed through a business process man ager according to an embodiment of the present invention FIG 5 illustrates an extraction of information from a form FIG 6 is a flow chart illustrating further details of process flow by an embodiment of the present invention FIG 7 is a schematic representation of an embodiment ofa system for use in creating a compliance report for chromato graphic instrumentation DETAILED DESCRIPTION OF THE INVENTION Before the present systems methods and computer read able media are described it is to be understood that this invention is not limited to particular hardware software or media described as such may of course vary It is also to be understood that the terminology used herein is for the purpose of describing particular embodiment
44. s as input said data in the native format from native software that controls the analytical instrument from which said data was outputted 32 The system of claim 22 wherein said technology neutral standardized format comprises AnIML Analytical Information Markup Language 33 A computer readable medium carrying one or more sequences of instructions for compliance testing of at least one of instrumentation and software wherein execution of one or more sequences of instructions by one or more pro cessors causes the one or more processors to perform the steps of converting data outputted from at least one analytical instrument or software to a technology neutral stan dardized format wherein said technology neutral stan dardized format is independent of instrument type instrument model instrument manufacturer and data type ofthe analytical instrument or software from which the data was outputted performing one or more calculations on the converted data to produce one or more outputs wherein said performing one or more calculations are performed according to instructions instantiated as forms selecting from said one or more outputs to populate a final report wherein the one or more outputs are standardized and are directly comparable to outputs resultant from said method carried out on another set of one or more other analytical instruments irrespective of manufac turer or model of the other analytical instruments and outpu
45. s on analytical instruments as well as other instruments As noted forms 200 may act as instructions for processes carried out by calculation engine as well as for data storage repositories of the results of these calculations Forms 200 can contain any combination of input types including inter active manual input information detected by software of system 100 and or the CDS of the instrument being consid ered and or calculated reduced data Forms 200 may further include launch points for executables that perform detection calculation or any other function called for by the process Forms 200 may be version controlled and stored as record of the data collection process leading to a resulting final report In this way the stored versions of forms can serve as an audit trail from the time of initial collection of the data all the way through to the time of the issuance of the final report Because of the standardization of all data to a technology neutral format and creation of metadata from the same cal culations by calculation engine may be carried out by calls to a consistent and tested library as the calculation are reusable and portable In order to manage data storage metadata extraction and archival of data as well as compilation of final reports and other form management functions system 100 may employ an enterprise content manager ECM 404 as noted earlier ECM 404 may provide a secure platform on which to manage the functions
46. s only and is not intended to be limiting since the scope of the present inven tion will be limited only by the appended claims Where a range of values is provided it is understood that each intervening value to the tenth of the unit of the lower limit unless the context clearly dictates otherwise between the upper and lower limits of that range is also specifically disclosed Each smaller range between any stated value or intervening value in a stated range and any other stated or intervening value in that stated range is encompassed within US 7 440 863 B2 3 the invention The upper and lower limits of these smaller ranges may independently be included or excluded in the range and each range where either neither or both limits are included in the smaller ranges is also encompassed within the invention subject to any specifically excluded limit in the stated range Where the stated range includes one or both of the limits ranges excluding either or both of those included limits are also included in the invention Unless defined otherwise all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs Although any methods and materials similar or equivalent to those described herein can be used in the prac tice or testing of the present invention the preferred methods and materials are now described All publications mentioned herein
47. scribe each of these options Thus for example if an owner has a particular type of sound system but there are six different sound system options for the owner s car in order to access information about the sound system the owner will typically have to page through descriptions of all six sound systems options in the user s manual until the matching sound system is found An automated report application for owner s manuals would pre pare this user s manual based upon the options chosen by the owner so that when the owner looked up the description of the sound system only one sound system would be described in the owner s manual i e the description for the sound system actually selected by the owner for his her car The automatically populated forms 200 as well as the final report 444 may be stored into ECM 404 so that ECM 404 is the location of the initial collection calculation meta data and final data as well as audit trails Thus system 100 may include a relational database with tools such as data reduction engine 302 calculation engine 306 and record mining engine 440 for example sitting on top of it Reports 444 can take on any form and may be selected by auser For example a report may be created in summary form or in full detail with or without a logo etc While the reports 444 are customizable the underlying forms 200 created by the system 100 do not change so that standardization is pre served Auto docume
48. ts irrespective of manufacturer or model of the other analytical instruments Systems tools methods and computer readable media are provided for standardizing characterizations of at least one of analytical hardware and controlling software during compli ance testing Algorithms are provided for converting data from a native format as outputted by an analytical or other instrument to a technology neutral format A data reduction engine is configured to reduce the data to a technology inde pendent reduced metadata set A calculation engine is con figured to perform at least one calculation on at least one of the data converted to a technology neutral standardized for mat and the reduced metadata set to produce one or more outputs required for a set of predefined criteria Systems tools methods and computer readable media are provided for compliance testing at least one of instrumenta tion and software including displaying a test protocol on a user interface and prompting a user to input information regarding results of a test prompting at least one instrument or software associated with an instrument to initiate the test protocol in response to an input by the user into the test protocol displayed on the user interface or results from another instrument in response to a test protocol run on the another instrument and automatically calculating results of the test protocol run on the at least one instrument These and other advantage
49. tting at least one of at least one of said outputs and said final report UNITED STATES PATENT AND TRADEMARK OFFICE CERTIFICATE OF CORRECTION PATENT NO 7 440 863 B2 Page 1 of 1 APPLICATION NO 11 119255 DATED October 21 2008 INVENTOR S Manfredi It is certified that error appears in the above identified patent and that said Letters Patent is hereby corrected as shown below On the Title page item 56 under Other Publications in column 2 line 2 delete ow and insert row therefor In column 17 line 47 in Claim 23 delete enginOe and insert engine therefor Signed and Sealed this Thirtieth Day of December 2008 WT JON W DUDAS Director of the United States Patent and Trademark Office
50. ument is just a series of changing signals over time Reduction engine 302 converts these signals hav ing been converted to a technology neutral format into use able data e g peak area noise calculations etc which can be fed to calculation engine 306 e g there are 5 peaks and those 5 peaks have peak areas of 2 2 1 1 9 2 and 2 and the mean is X with standard deviation of Y etc so that these values can be compared to an acceptance standard or with like values calculated with regard to another instrument 612 Depending upon the instrument that has generated the data a data reduction engine 302 may not even be needed For example a balance already outputs data that 1s reduced to numbers that are useable by calculation engine 306 and so this data doe not need to be further reduced although it may need to be converted to a technology neutral format Further other alternative reduction engines 302 may be included with the system 100 as part of a library that may be accessed for non standard reduction requirements By performing data reduction with a component of system 100 this separates reliability on each instrument s software for performing such functions Accordingly all data reduction is standardized across reports that are prepared by system 100 and perfor mance is all standardized by evaluation by the same system Further since the data is standardized only one method need be developed to produce a particular type of
51. vides scalability to the present system Referring to FIG 1 data is inputted to the system in its native format at event 110 for initial conversion to a technol ogy neutral format event 120 so that all further processing is with respect to data that is all in the same format regardless of which instrument was used to originally output the data in its native format Data reduction may be performed at event 125 by a data reduction engine as described below if needed By performing calculations further processing event 130 on technology neutral formatted data with the present system calculations are thereby standardized so that results event 140 are directly comparable between data produced by vari ous instruments models and manufacturers The standardiza tion is made possible by the system s ability to convert data from external sources into a technology neutral format which is then data reduced and calculated by common components Further this standardization may be applied to data sources manually semi automatically requiring some manual appli cation or automatically and such data may require data reduction or may be in a ready to process form In this way data that characterizes the operation of instrumentation or controlling data systems can be used for the purposes of qualification of said device irrespective of proprietary or native format One non limiting example of a technology neutral format that may be employed by the
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