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Scalable integrated tool for compliance testing

1. UIT p pu ouuutooaq uI9js 00 s CoS o uoneorgroedg Jas SWI popueuruiooo uI9 s S Aoeinooy ILY MOLT 050 jo adoods ut s 10j Hoo euorjoun Ios IY JIU 159 STU JO sjutod jos pue spun asodind our 90u219 2y 19u101SnO 1591 JU UNY 9cc SHUIPBSI AO KIS ou Jo ASA oy Se peye no eo si UOISIDIIA MO pue jutodjos ay pue sSBuIpeal MOJJ XIS 94 JO ULIULI aq 22ua13jJIp 94 3jn osqe 94 se poje nojeo SI oe1n29 y MOJA 9 81 MO J U9A OS JO UOISIo9Jd pue vel DS DY uttttt9 p 0 19J tuAo j PJ131P poje1qi eo L SISN 753 SIY L ZZE UOISID9IJ pue oe1nooy MOTT d JUSA OS NvCC NEEC NvYC Noo 00Z US 7 890 285 B2 Sheet 9 of 9 Feb 15 2011 U S Patent oads jueumusur guore1ed dads yu ummsur poj ejsur MIN UOISIO2Jq ads jueumujsur euore1ed o dads yuoummnsutr po e sut MIN ALn oy O Z Ney MOLT oads yu umansu euone1oed Qo 050 gt gods justunysu poj eisut MIN UOISI22Jd A gt dads JUJWNIJSU euonelado 00 4 gt dads pown ysu po e1sur MIN pepu uruoo q Ko 1nooV zZ z mnunuqu A 001 IVY MOJA 9e sur JeoK ouo Joye esn jeuore1odo Ul 1 JO pue S pejjeisur Amou 10 sjuotua1nbos 1os IY SQUIJOP 189 SIL J9U919J9Y 19luo1snO 389 JU un 907 SSUIPB91 MOTI XIS ou JO ASA 2U Se pere no eo st uorstooud MO y pue jurodjos ar pue sSurpea1 o XIS 3y JO ueaur JU 99u919JJIp einjosqe 94 se poje no vo
2. 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 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 select the proper entry or manually input an entry such as by typing cutting and pasting scanning or some other alternative data entry mechanism that requires intervention on the part of the user Further alternatively the user interface 250 may be optionally used to enter all data required by a form either as a result of user preference to do so or because an instrument being considered is sufficiently old or unsophisticated so as to lack a sophisticated enough software interface to supply some or all of the data automati cally 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 pro
3. 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 ifthe instrument s data is proprietary data the proprietary data may be converted to technology neutral formatted data e g AnIML etc using data system control API s 602 or if provided in human readable form the data may be added to the forms manually and included into quali fication processing with any required calculations or may be converted from an analog signal outputted by the instrument to a digital signal inputted to the system and both the propri etary data and the converted technology neutral A D con verted and or manually inputted data may be saved in ECM 404 The 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 provide an input file to reporting engine 608 to correctly populate a report Once final report 444 has been generated BPM 406 c
4. at least one of said instrument and said controlling software 29 The system of claim 24 wherein said outputs are stored on said forms 30 The system of claim 29 further comprising means for mining said forms to extract metadata needed to produce a final report 31 The system of claim 30 further comprising means for compiling the extracted metadata into the final report 32 The system of claim 24 further comprising a user interface configured to facilitate manual input to at least one of said interactive forms by a user 33 A non transitory computer readable medium carrying one or more sequences of instructions for compliance testing wherein execution of said one or more sequences of instruc tions by one or more processors causes said one or more processors to perform inputting data from at least one analytical instrument converting said inputted data to a technology neutral for mat if said inputted data is not already in said technol ogy neutral format performing one or more calculations on said inputted data in said technology neutral format to produce one or more outputs comparing at least one of said outputs to first and second test limits indicative of said instrument s performance and reporting compliance status of said at least one output based on said comparing to said first test limit and to said second test limit 34 A computer implemented method of compliance test ing at least one of instrumentati
5. be pro vided for qualifying equipment and may be used for record ing test specification and report definitions in making quali fication protocols Each protocol may contain tests with set points and limits required to be executed on any single instru ment or named group of equipment Although FIG 8 shows an example of a form 200 for testing flow accuracy and precision of solvent flow rate in a liquid chromatography apparatus other tests forms that may be included in a quali fication protocol for such a liquid chromatography apparatus include but are not limited to accuracy and stability of col umn temperature wavelength accuracy signal noise and drift injection precision and carry over response linearity solvent gradient composition accuracy stability and linearity and sample temperature accuracy Of course qualification by the present system 100 and forms 200 are not limited to liquid chromatography apparatus but may be applied to other instrumentation softwares and hardwares as indicated above A default list of tests set points and limits may be provided for each type of qualification and instrument that may be qualified by the system 100 using recommended tests The default set of tests may be accepted by a user ora user selected set of tests optionally with user selected set tings can be used for a custom configured qualification pro cedure While FIG 8 is described with reference to a flow accuracy and precision
6. burdening the hardware qualifi cation event with data reduction evaluation ofthe 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 theloop and effectively separating the instrument s hardware from the associated software so that the report can focus on the hardware independent of qualifying the instrument s controlling software The modularity provided by system 100 facilitates modu 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
7. 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 Alternatively the system may operate independent of an enterprise content manager to perform data reduction calculations and output results as well as other forms based functions as described herein One non limiting example of an ECM that may be employed is a Cerity ECM available from Agilent Technologies Inc Since an ECM is an enterprise system it also provides 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 conversion may be performed when the system is associated with an ECM content manager by the ECM content manager Alternatively data may be provided to the system that 1s already in a technology neutral format as for example when an instrument owner converts the output ted instrument data to a technology neutral format and then this converted data is directly inputted to the system Under this option the system does not perform events 110 and 120 as the data inputted is already in a technology neutra
8. issuance of the final report When standardizing all data to a technology neutral format and creation of metadata from the same calculations by cal culation engine may be carried out by calls to a consistent and tested library as the calculations 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 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 prepa
9. one of said forms contains said first and second test limits 17 The method of claim 16 wherein at least one of said first and second test limits is user specifiable 18 A computer implemented method of compliance test ing said method comprising inputting data from at least one analytical instrument converting said inputted data to a technology neutral for mat if said inputted data is not already in said technol ogy neutral format performing one or more calculations on said inputted data in said technology neutral format using a computer implemented analytical instrument compliance system to produce one or more outputs comparing at least one of said outputs to first and second test limits indicative of said instrument s performance and reporting compliance status of said at least one output based on said comparing to said first test limit and to said second test limit 19 A method of compliance testing at least one of analyti cal instrumentation and analytical instrumentation software said method comprising displaying a test protocol form configured for said compli ance testing of said at least one of analytical instrumen tation and analytical software on a user interface and prompting a userto input information regarding a test for qualifying a result of the test prompting at least one analytical instrument or analytical instrument software associated with an analytical instru ment to initiate the test protoco
10. process ing Using the methods and systems described herein non vendor specific instrument qualifications may be processed using a native controlling software of an instrument 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 as already noted above 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 information 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 FIG 8 shows an example of a form 200 that may
11. 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 ina very predictable standardized way which is an important consideration for qualification and compliance reports Once native data has been converted into technology neu trally formatted data or alternatively after converting analog signals outputted from an instrument to digital signals or after receiving digital output signals from an instrument US 7 890 285 B2 7 metadata may be created by data reduction engine 302 FIG 3 ofthe 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 applica tionto chromatography the present system does not rely upon the software 12 running the chromatography instrument 10 from which the raw data is generated to determine what is a peak in the data or where to define the location ofthat peak as such determinations are made based upon calculations and algorithms run by the data reduction engine 302 ofthe present system Data reduction engine 302 reads the data having been converted into technology neutrally formatted data or other wise and converts this digital representation of an analog function into data representing features described ch
12. systems methods and computer read able media are described it is to be understood that this invention is not limited to particular hardware software for mats 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 embodiments only and is not intended to be limiting since the scope of the present invention 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 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 on
13. test it is noted that common features that apply to forms 200 for other quality tests are described here The test name 222 is typically provided by the system although for custom designed tests form 200 may allow editing ofthe test name 222 A brief test description 224 may also be provided Field 226 may be manipulated by the userto run the identified test 1 e Run as shown or to omit running this test by US 7 890 285 B2 17 toggling the field to Don t Run for example by selecting button 227 to visualize a drop down menu from which to select either Run or Don t Run The customer reference field 228 allows the user to input a description tailored to the user s needs for easily identifying describing the test that is being performed wherein specific equipment tested may also be identified Test settings 230 such as flow rates for this example are typically preset by the system but may be modified by a user for customized testing and many other purposes such as by selecting from a drop down menu of available settings when selection on button 231 FIG 9 shows another example of a form 200 that may be provided for qualifying equipment and may be used for recording test specification and report definitions in making qualification protocols in which dual limit features are used for qualifying instruments according to their age or number of hours of use In this example the limits fro newly installed instrum
14. 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 200 may also be constructed as a mixed model where some elements of the forms 200 are automatically filled in when the data is avail ableto the system When data is not available to the system for automatically filling in the forms 200 such data can be inter actively 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 then automatically enters it into the form 200 from which the request originated If autodetection engine 720 is unsuccessful in automatically retrieving some or 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 of th
15. typically contains a set ofcalculations for performance ofthe standard ized tasks in the back end processing e g calculation iden tification of peaks calculation of statistics describing the 0 jak 5 20 40 45 55 65 8 data etc With respect to data reduction and calculation the results may be standardized and independent of the originat ing data system or controlled instrument as noted above Reports based on those results are fully customizable as reports ranging from simple summary reports to traditional fully described compliance protocols may be outputted The library can be modified typically added to to increase functionality but it does not have to be a different library based on 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 ev
16. 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 732 may be embod ied by completed forms 200 without the need to data mine such forms Further alternatively a final report may be com piled by mined data that i
17. EU RAE Perform Calculations Output UTE Results 130 140 US 7 890 285 B2 Page2 U S PATENT DOCUMENTS 2006 0247878 Al 11 2006 Manfredi 702 108 2006 0247885 Al 11 2006 Manfredi 2008 0059123 Al 3 2008 Estbergetal 702 188 702 108 707 203 2008 0201098 Al 2008 0215638 Al OTHER PUBLICATIONS 8 2008 Manfredi 9 2008 Manfredi metadata Webopedia 2007 2 pages Office Action dated Jan 29 2010 in U S Appl No 12 150 030 for Integrated Tool For Compliance Testing Within An Enterprise Con tent Management System Agilent Cerity Pharmaceutical for QA QC http www chem agilent com Scripts PDS asp IPage 272 pp 2 Mar 3 2005 Waters Laboratory Informatics Empower TM Chromatography Data Software http www waters com watersdivision contentd asp watersit JDRS 5K XPGA pp 2 Feb 18 2005 SSI Chromatography Data System http www scisw com prod ucts cds index2 htm pp 2 Mar 3 2005 Agilent Cerity Enterprise Content Manager ECM http www chem agilent com Scripts PDS asp IPage 16769 pp 1 2 Feb 19 2005 AnIML Analytical Information Markup Language http animl sourceforge net pp 1 8 Feb 19 2005 Microsoft Office Online Visio 2003 Home Page http office microsoft com en us FX010857981033 aspx pp 1 2 Apr 28 2005 FormMax E Forms Software for Business Forms Designing and Filli http www cutepdf com Produ
18. OWG XIW weays lt lt 0 0 00 01 00 A O 0 xiney T gd A JLWSIOJ ADHGE 9dAqns xoy Aqg 9s o1d 0 0 1e n82r 01g peu AJA 100 1 5224n0s23 00160 01 ETOEES SS 0 0 0 0 xoagaoe qox ed amp p g1t uisus 1 fqo 0 81 1olqepuaq lt lt jadA pjadAqns s yeqsuiqidezjuo yaseg qqeZ awen au yyad lt lt fqo 0 S11efqepuao nu qolO p efqousdo lt lt q oweu 3usumasu 9 uuojqnsj 9 juuoj v LL lt MJAU PI9 4 1X2 LJ 1L 00701 1e1n323 o1g pe uANJ L V A A 0 1 nareqionas st 0911 OL v1v jausurussuj S UISUGAO omen 3usunnsug JAq iy 0 6 dnesprpyedhaqns x L LACC0v 1p LEI ATASAINLEZ GZOETE LZP SOOTSE TI ZHOU A 8 1uo1e d 10uu v od p 4 22 qo 0 6b0 8opu l 0 0 9u is q eqopy 1eonpoud 9 ayouSiso 930p v 1017212 00 F0 FPS T9161 a TF00 C Gd 91equongo12 00 60 199 16 19 II TE00 C0 9e QPOW fqo 0 L qepuoq inn POWOJENNY O LII PERNA dq g 1009221 112018 3 q 00 c dpx dpx ut O 86 12s9 e201 s a 96 sieseiep y a r g eidu u 0 z6 Suuo q q oe dpx dpx v 4x 8 a LL 0 ISW OVQ u A 05 1eINsay q4dloeUAWYY 0 SHT JUOA 9IJAO Y O IEspior 2 uueg JOJ9Y Y O gg soueN So pe2 sdA w O c s9Seg 22 qe 0 Tofqopuo jueonspuo ojo y o przpoqox 15 lt lt 8 1 r xepuj zat 0 10 NII 9 X ed AL O JAV lt lt Z 101o1paug p suumn oj suueqepoosq apoosqa18 4 191114 1 I y 3uoT lt geLzL MO 1960686PPC t169 3529 14250031009 089502 96LvLFLG S1C880968 QUI 01 LOOS 611 2z s gt gt fq2 O git 7 ewon yo jueu
19. TIONS filed on Apr 29 2005 now Pat No 7 440 863 Standardization of data ow for laboratory automation soft on XML 51 Int Cl technology IEEE Xplore Oct 2006 2 pages nt Cl GOIR 31 00 2006 01 Continued G06F 11 30 2006 01 y i G21C 17 00 2006 01 Primary Examiner Michael P Nghiem 52 USCh tete tree 702 120 702 182 57 ABSTRACT 58 Field of Classification Search 702 108 67 702 182 189 120 81 115 117 118 703 21 A is file anemia 103 22 Methods tools systems and computer readable media for compliance testing instrumentation and or software Data pp p ry li SATA d fw D 56 References Cited from one or more analytical instruments and or software is U S PATENT DOCUMENTS 5 280 617 A 1 1994 Brender et al 717 159 5 841 771 A 11 1998 Irwinetal 370 360 5 878 383 A 3 1999 Carter 702 182 5 961 448 A 10 1999 Swenson etal 600 301 6 054 865 A 4 2000 Baldetal 324 551 Input Data in Native Format inputted and calculations are performed on the data to pro duce one or more outputs At least one of the outputs may be compared to first and second test limits and compliance status of the at least one output relative to the first and second test limits is reported 37 Claims 9 Drawing Sheets 110 120 Convert Data to Technology Neutral Format soe Dam Redaction 1 based on Technology Neutral 17 125 RM Fo
20. The method of claim 9 further comprising storing said forms in a database as a repository of processed data 14 The method of claim 13 further comprising identifying an audit trail based upon forms and data stored in the data base 15 A computer implemented method of compliance test ing said method comprising inputting data from at least one analytical instrument or controlling software of an analytical instrument to a system performing one or more calculations on said inputted data using a computer implemented analytical instrument compliance system to produce one or more outputs selecting from said one or more outputs to populate a final report wherein said one or more outputs are standard ized and are directly comparable to outputs resultant from said method carried out on another set of one or more other analytical instruments or controlling soft wares for analytical instruments irrespective of manu facturer or model of said other analytical instruments comparing at least one of said outputs to first and second test limits indicative of said instrument s performance wherein said comparing is performed according to instructions instantiated as forms and 5 15 20 25 30 35 40 45 50 55 60 65 20 reporting compliance status of said at least one output relative to based on said comparing to said first test limit and to said second test limit 16 The method of claim 15 wherein at least
21. US007890285B2 az United States Patent 10 Patent No US 7 890 285 B2 Manfredi 45 Date of Patent Feb 15 2011 54 SCALABLE INTEGRATED TOOL FOR 6 456 955 Bl 9 2002 Andrews et al COMPLIANCE TESTING 6 876 941 B2 4 2005 Nightingale 702 120 6 978 218 B1 12 2005 Kolb et al 75 Inventor Charles Manfredi Oakhurst NJ US 7 440 863 B2 10 2008 Manfredi 702 108 I 2002 0156757 A1 10 2002 Brown 707 1 73 Assignee Agilent Technologies Inc Santa Clara 2002 0183956 Al 12 2002 Nightingale 702 120 CA US 2002 0192624 Al 12 2002 Darby etal 434 236 Notice Subject to any disclaimer the term of this 2003 0008648 Al 1 2003 Bims et al patent is extended or adjusted under 35 2003 0084340 Al 5 2003 Schertz et al U S C 154 b by 349 days 2004 0109453 Al 6 2004 Wirth 2004 0128646 Al 7 2004 Jindal et al This patent is subject to a terminal dis 2004 0145598 Al 7 2004 Parent et al claimer 2005 0071720 A1 3 2005 Dattaram et al 2006 0041840 Al 2 2006 Blairetal 715 513 21 Appl Ne 11 286 195 2006 0077895 Al 4 2006 Wright 22 Filed Nov 22 2005 2006 0155411 Al 7 2006 Khocheetal 700 108 2006 0161836 A1 7 2006 Thomson etal 715 505 65 Prior Publication Data US 2006 0247885 A1 Nov 2 2006 Related U S Application Data Continued 63 Continuation in part of application No 11 119 255 OTHER PUBLICA
22. aluated 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 be applied to 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 personnel 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 t
23. an 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 what you see is what you get author ing capability may be provided by the forms designer appli cation for designing forms 200 Secure data handling is ensured by ECM 404 Standardized results are the end prod uct 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 compliance 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 10 20 25 30 35 40 45 50 55 60 65 12 Such reduction provides checks on the interplay between the hardware and software of a system to be qualified at each qualification event without
24. 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 schematic representation of an embodiment of system 100 is shown for use in creating a compliance report for chromatographic instrumentation Sys tem 100 is represented as interfacing 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 ofthe 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 mixed vendor modules as noted above Forms 200 which may optionally be driven by BPM 406 in which case forms 200 may be presented to a user by placement into a user specific inbox e g BPM Inbox 706 that functions similarly to the inbox of an e mail service are presented to a user of system 100 for forming a compliance report For example simple instructions can be provided in a wizard like environment 1 e where simple tasks are com pleted sequentially and interactively Thus if a message is placed in inbox 706 that instructs a simple task to be per formed once t
25. aracter ized 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 consis tent results are determined for data across the board whether a particulartype ofinstrument 10 was manufactured 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 Asone example signal data from a chromatography instru ment 612 as inputted to system 100 by the native controlling software for the instrument is just a series of changing signals over time Reduction engine 302 converts these signals which may or may not have been converted to a technology neutral format into useable data e g peak area noise calcu lations 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 is reduced to numbers that are useable by calculation engine 306 and so this data does not need to be further reduced although it may be converted to a t
26. cts FormsMax pp 1 2 Feb 18 2005 Revision of ChemStations Plus Agilent Technologies http www laboratorytalk com news agi agi134 html pp 2 Jan 15 2002 cited by examiner U S Patent Feb 15 2011 Sheet 1 of 9 US 7 890 285 B2 120 Perform Data Reduction 3 based on Technology Neutral 2 125 a Formatted Data E s w s oe Perform Calculations 190 l Output Standardized FIG 1 US 7 890 285 B2 Sheet 2 of 9 Feb 15 2011 U S Patent c DE OSC Ob 88SOLSHTT AI INWIN esueor JaquiNN elas cz reen OLC 30 u sopiejoA O BOC paxoeg po3mg O 90 ss nnds Yds O VOZ No uonduoseq JouuryD WA Qum ano TUB JUSTIN nsu J9UUBU O 1831 pue uiojs S e1ouor US 7 890 285 B2 Sheet 3 of 9 Feb 15 2011 U S Patent DIJ Sj nsow pozipiepurys 80 001 gi urduq uong no eO 90t ourguq uononpew eje COE Cl syusumnsu 01 U S Patent Feb 15 2011 Sheet 4 of 9 US 7 890 285 B2 100 404 406 Data Storage and Extract Using Mining Engine Format Conversion Automated Report Generator Calculation Engine Customizable Report FIG 4 US 7 890 285 B2 Sheet 5 of 9 Feb 15 2011 U S Patent DIJ 07 TOS GOA SIOOLSOLL Qu umnsu soieuo OTI 1 HGOL S0681 TUL OF 1613231 qd aeuAT 0 LgouAvoar go s 8 8 T Inb0
27. d forms contain data generated from at least one of interactive manual input information detected by a UNITED STATES PATENT AND TRADEMARK OFFICE CERTIFICATE OF CORRECTION PATENT NO 7 890 285 B2 Page 1 of 1 APPLICATION NO 11 286198 DATED February 15 2011 INVENTOR S Charles Manfredi It is certified that error appears in the above identified patent and that said Letters Patent is hereby corrected as shown below In column 20 line 2 in Claim 15 after output delete relative to Signed and Sealed this David J Kappos Director of the United States Patent and Trademark Office
28. ded limit i e 5 00 The user may modify a limit by selecting the button 233 or 235 corresponding to the limit to be modified and selecting a value from a resulting drop down menu of values Thus a user may individually modify any single limit 232 or 234 to a value that is less stringent or more stringent than the corresponding limit 234 or 232 in that dual limit set for a particular test In the example of FIG 8 the user has set the user specification limits 232 for accuracy and precision to be less stringent and more stringent respectively than the rec ommended limits with regard to Flow Rate 1 For Flow Rate 2 the user specified limits 2322 have been left equal to the recommended limits 234 The names 232N and 234N for each respective limit may also be user modifiable to name the limits appropriately as can be noted in the names that have been entered by the user in the example of FIG 9 For example terminology naming the limits 1 e names 232N and 234N can be modified by the user to match the corporate glossary procedural requirement or department preferences or practices The operator fields 238 for the limits may also be user modifiable For example the user may select button 239 and select a E operator or a operator As another example of the use of dual limits the user may want to make limits 232 more stringent than limit 234 so that ifthe instrument passes limit 234 but fails limit 232 the user is
29. e configured to reduce data outputted by an analytical instrument a calculation engine configured to perform at least one calculation on at least one of said data outputted by an analytical instrument and the reduced data to produce one or more outputs required for a set of predefined criteria and US 7 890 285 B2 21 interactive forms comprising computer executable format executable by said system to provide instructions executable by said data reduction engine and said calcu lation engine said forms providing procedural informa tion including calculation instructions wherein said interactive forms provide instructions for cal culating outputs to answer one or more questions relat ing to one or more performance tests designed to deter mine compliance of the at least one of analytical instrument and controlling software 25 The system of claim 24 wherein said data reduction engine reduces said data to a technology independent reduced metadata set 26 The system of claim 24 wherein at least one of said interactive forms includes dual test limits 27 The system of claim 24 further comprising algorithms for converting data from a native format as outputted by an analytical instrument to a technology neutral format 28 The system of claim 24 further comprising an auto matic detection engine configured to determine at least one of instrument and controlling software specific information to automatically characterize said
30. e inputted data may be performed by system 100 optionally by ECM 404 as controlled by BPM 406 in accordance with the instructions contained in forms 200 selected for processing the data wherein forms 200 identify the particular data that is needed In this example data may be converted to AnIML formatting 724 or other common data form CDF such as AIA Ana lytical Instrument Association or ANDI Analytical Data Interchange format typically annotated with CDF exten sions When converting to AnIML Native Data AnIML package 726 may be employed to provide store the data in the AnIML format as well as in the native CDS format Analog data from an instrument may be A D converted into a stan dardized format 724 for use by the system 100 such as ATA or Native EZC format or other compatible input format to reduction engine 302 for example In any case once the data is converted data reduction engine 302 whether integrated to ECM 404 or standalone 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 which may optionally be guided by BPM 406 as noted above Reprocessing data reduction calculations can be can be driven by API so that no user interface is required 1 e No GUI Reprocess 728 Thus data can be inputted directly from an instrument s operating software 704 to instrument 100 where it may be converted to a tech
31. e 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 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 limit includes a plurality of such limits and reference to the form includes reference to one or more forms and equivalents 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 dive
32. e outputs to first and second test limits and reporting compliance status of the at least one output relative to the first test limit and to the second test limit Methods systems and computer readable media are pro vided for compliance testing at least one of instrumentation and software to display a test protocol form on a user inter face and prompt a user to input information regarding a test for qualifying a result of a test prompt 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 automatically calculate results of the test protocol run on the at least one instrument and output status of the results as determined by at least one set of dual test limits A system for standardizing characterizations of at least one of analytical hardware and controlling software during com pliance testing is provided to include a data reduction engine configured to reduce outputted by an analytical or other instrument a calculation engine configured to perform at least one calculation on at least one of the data outputted by an analytical or other instrument and the reduced data to produce one or more outputs required for a set of predefined criteria and interactive forms providing procedural information including calculat
33. e performance tests designed to determine compliance of said analytical instrument or software under consideration with a set of predefined criteria indicative of said instrument s per formance 37 A computer implemented method of compliance test 50 ing said method comprising inputting data from at least one analytical instrument or controlling software of an analytical instrument to a system performing one or more calculations on the inputted data to produce one or more outputs 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 or controlling softwares for analytical instruments irrespective of manufacturer or model of the other analytical instruments comparing at least one of said outputs to first and second test limits and reporting compliance status of said at least one output based on said comparing to said first test limit and to said second test limit 10 15 20 30 35 40 45 55 60 65 US 7 890 285 B2 23 24 wherein said performing one or more calculations are per system performing said method and software of system formed according to instructions instantiated as forms acomputerized data system ofan instrument from which and data is being converted and calculated reduced data wherein sai
34. echnology neutral format Further other alter native 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 performance is all stan dardized by evaluation by the same system Further since the data is standardized only one method need be developed to produce a particular type of 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 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 For consistent raw data sets 1 e technol ogy neutrally formatted data received by data reduction engine 302 these data sets can be properly manipulated 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
35. em 100 For example certain forms 200 may contain specific instructions for calculations to be performed by calculation engine 306 Thus forms 200 can be interactively filled out by a user through 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 of the 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 o
36. ents have been chosen by the user to match the limits recommended 236 by the system form 200 while a second ary set of limits 234 in this example have been chosen to be less stringent than the first set of limits 232 and are to be used for instruments that have been in operation for a year or more and for which it is generally accepted that a less stringent performance limit can be applied to account for normal wear and tear and mechanical degradation Regardless of what the first 232 and second 234 limits are chosen to be by a user the system recommended limits 236 are always provided in forms 200 For example the recommended limits 236 pro vided may be provided as specifications typically found to meet international industry standards and regulatory expec tations in the judgment of the protocol developers Dual test limits i e a more stringent limit and a less stringent limit may be provided for any or all tests per formed The forms 200 may have system recommended limits preset in both sets of limits which are then modifiable by a user as noted in the example of FIG 9 above In the example shown in FIG 8 the user has maintained the system preset limits in limit set 234 and limits 232 have been modified to less stringent limits The user specification second limit 232 forFlow Rate 1 Accuracy has been changed to a less stringent limit 1 e 10 00 than the corresponding limit 234 which in this case is left at the system recommen
37. ess 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 present system is referred to as Analytical Information Markup Language AnIML see http animl sourcefor ge net 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 the system 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 As noted the data collected may alternatively be collected in analog form and A D converted for input to the system Origi nal data which may be preserved for possible reanalysis by the native CDS may also be converted to an accepted tech nology
38. etermine at least one of instrument specific information to automati cally characterize said instrument and interactive forms comprising computer executable format that provides instructions executable by said data reduc tion engine said calculation engine and said automatic detection engine said forms providing procedural infor mation including calculation instructions 36 A computer implemented method of compliance test ing said method comprising inputting data from at least one analytical instrument or controlling software of an analytical instrument to a computer implemented analytical instrument compli ance system converting said inputted data to a technology neutral for mat if said inputted data is not already in said technol ogy neutral format performing one or more calculations on said inputted data in said technology neutral format using said computer implemented analytical instrument compliance system to produce one or more outputs and selecting from said one or more outputs to populate a final report wherein said one or more outputs are standard ized and are directly comparable to outputs resultant from said method carried out on another set of one or more other analytical instruments or controlling soft wares for analytical instruments irrespective of manu facturer or model of said other analytical instruments wherein said calculations are performed to answer a series of questions relating to one or mor
39. f forms 200 during processing For example a master form may be set up to feed other process forms A master form generally contains information that is globally the same with respect to all process forms that it feeds Accordingly this permits 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 to configuration details e g a stack of instru ments 612 and or override limits for specific equipment 20 25 30 35 40 45 50 55 60 65 16 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
40. he 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 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 vices on analytical instruments as well as other instruments As noted forms 200 may act as instructions for processes carried out by calculation engine 306 as well as for data storage repositories ofthe results ofthese calculations Forms 200 can contain any combination of input types including interactive 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 US 7 890 285 B2 9 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
41. he task is performed or Done then the next task can be emailed or placed into inbox 706 At event 708 whether or not BPM 406 is employed a user or manager assigning tasks to a user may choose the type of test or qualification to be performed In response to this choice sys tem 100 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 processing herein these forms 200 associated with a qualification event may contain simple instructions for processing with no data entry poten tial Forms for Acquisition Process 714 provide another option for processing according to forms associated with a US 7 890 285 B2 13 gualification event in which forms 200 may describe the setup ofthe native data system to perform specific runs and acguire specific data from the instrument and or software to be guali fied Those same forms 200 may provide controls for entry which may be manual and or automated of the 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
42. her BPM 406 together with ECM 404 may track the review process and store records ofthe same to maintain the chain ofthe audit trail 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 or to 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 t
43. identified as such and knows that the instrument in this 20 30 35 40 45 50 55 18 case passes the qualification but may not meet internal stan dards Or this may alert the user that the instrument although currently passing should be tested more frequently as it may need recalibration and or repair soon since it failed the more stringent limit In other instances a user may want to set user limits 232 less stringently than the recommended limits 234 depending upon the user s needs Thus for example if something less stringent than the system s recommended limit is still a useful or useable limit for the user s intended purpose then the user may set limit 232 to be less stringent than recommended limit 234 Upon running a dual limit test the resulting status ofthe equipment tested is outputted Default status names provided by the system include Pass Pass recommended limit only and Fail where Pass indicates the test result meets both of the set limits 232 and 234 Pass recommended limit only indicates that the test result mess the less stringent limit but not the more stringent limit and Fail indicates that the test result does not meet either limit These status names may also be user modifiable to any name or term desired 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 ar
44. ion instructions These and other advantages and features of the invention will become apparent to those persons skilled in the art upon reading the details of the methods systems and computer 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 of a system for use in creating a compliance report for chromato graphic instrumentation FIG 8 illustrates another example of a form used in per forming a test and qualifying test results against dual test limits US 7 890 285 B2 3 FIG 9 illustrates another example of a form used in per forming a test and qualifying test results against dual test limits DETAILED DESCRIPTION OF THE INVENTION Before the present
45. l either in response to an input by the user into the test protocol displayed on the user interface or in response to results from another analytical instrument in response to a test protocol run on the another analytical instrument automatically calculating results ofthe test protocol run on the at least one analytical instrument and outputting status ofthe results as determined by comparing said results to at least one set of dual test limits 20 The method of claim 19 further comprising inputting a first test limit value by a user of at least one of said at least one set of dual test limits 21 The method of claim 20 wherein a second test limit value of said at least one set of dual test limits in which said first test limit was user inputted is automatically preset 22 The method of claim 21 wherein said first test limit is more stringent than said second test limit 23 The method of claim 19 further comprising selecting from said one or more outputs to populate a final report wherein said 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 ofthe other analytical instruments 24 A system for standardizing characterizations of at least one of analytical hardware and controlling software during compliance testing said system comprising a data reduction engin
46. l format US 7 890 285 B2 5 As another option if data cannot be submitted to the system in a technology neutral format and an ECM is not employed the analog data outputted by an instrument may be received by the system and then converted via an A D converter to a digital signal to be inputted into the system The digital signal may be provided in a technology neutral format such as a cdf format e g AIA AnDI etc or proprietary formats such as bxx pts raw ch or dat for example Data reduction may be performed at event 125 by a data reduction engine as described below if needed By performing calculations fur ther processing event 130 on technology neutral formatted data or digital signals having been converted from the analog output ofan instrument with the present system calculations are thereby standardized so that results event 140 are directly comparable between data produced by various instruments models and manufacturers The standardization is made possible by the system s ability to convert data from external sources into a technology neutral format input of data that is already in a technology neutral format or read proprietary data which is then data reduced and calculated by common components Further this standardization may be applied to data sources manually semi automatically requir ing some manual application or automatically and such data may require data reduction or may be in a ready to proc
47. loyed 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 data base 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 documentation 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 a system employing an ECM 404 and BPM 406 is shown As noted above a user interface may or may not be needed which may depend upon the choice ofthe user the type
48. mujsu SSIDYD woy JUJWNIISU qQ ZAI d Lb Al9H US 7 890 285 B2 Sheet 6 of 9 Feb 15 2011 U S Patent 9 DIA 9 juauinsu 3ueumnsuj 019 3199 PUB MINIY papaq Wd 909 wla sAg eje T sauoumsug p 1u umnsur JUJUNMIJSUT JUJUMISUT UGUA suntoday USA sul 709 SIdV 04000 uI9 s S BBC 90 Surguq 3un1odoy uore no e 90v nda lt Ze 09 eutguq juaureSeue Al mE uononpay 2201d OST 198 Ilinc US 7 890 285 B2 Sheet 7 of 9 Feb 15 2011 U S Patent SULIO J popueddy L DIA dc HILI Jase MA Hotad 3 14 du posredu juoauin2o T yoday payewoiny yoday poreuioiny polapusy T v Y eJepejo eSexyosq ude ssaoo1doy E dum EN 10 VIV Iolo IND9 0N 1 meq i L oAneN TIG sao JUIBUJ uons no eo JOPUJA Auy oouer duro quauidinby JOPUJA PIXIJA ursuq uonoejeqony ve po oojegoin y 07 T sel 9 Due duro m uuoo enuey 103 SULIO4 lt o 7 d Hes gt 9IL OTL PIL TOP Sumo T fi 189 95004 ononnsu 80L n TIL IO SWOJ E xoqut Ndg 0011 a US 7 890 285 B2 Sheet 8 of 9 Feb 15 2011 U S Patent UV p opu uutuoo Wd SAS uoneortoeds las UOISIDIIJ slla gt gez UIT p pu ututoo q uuajs s SL Occ uoneoyioeds sN Keno y Z PY MOL W1 popuourum2o uoneorjroodg 1987 UOISI991d SETTA
49. 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 ofthe present system to different types of instruments and to instruments having different standards CDS s as a result of being 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 0 an 5 40 45 6 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 APT
50. nology neutral format and then fed directly to data reduction engine 302 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 20 25 30 35 40 45 50 55 60 65 14 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 also be provided for calculation engine
51. nstruction 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 mechanisms that have populated forms 200 An analogy to one function of the automated 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 describe 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 20 25 30 35 40 45 50 55 60 65 10 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 when an ECM is emp
52. ntrolling software of an analytical instrument to a system performing one or more calculations on the inputted data using a computer implemented analytical instrument compliance system to produce one or more outputs 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 or controlling software for analytical instruments irrespective of manufacturer or model of the other analytical instruments comparing at least one of said outputs to first and second test limits and reporting compliance status of said at least one output based on said comparing to said first test limit and to said second test limit wherein said performing one or more calculations are per formed according to instructions instantiated as forms 10 The method of claim 9 wherein said forms contain data generated from at least one of interactive manual input infor mation detected by a system performing said method a com puterized data system of an instrument from which data is being converted and calculated reduced data 11 The method of claim 9 wherein said forms include launch points for executables that perform functions per formed by said method 12 The method of claim 9 further comprising storing said outputs of performed calculations on the forms 13
53. on and software said method comprising the steps of inputting data from said at least one analytical instrument or software to a computer implemented analytical instrument compliance system performing one or more calculations on the inputted data using the computer implemented analytical instrument compliance system to produce one or more outputs comparing at least one of said outputs to first and second test limits wherein said comparing is performed accord ing to instructions instantiated as forms selecting from said one or more outputs to populate a final report and reporting compliance status of said at least one output based on said comparing to said first test limit and to said second test limit 22 wherein the at least one output is 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 manufacturer or 5 model of the other analytical instruments 35 A system for standardizing characterizations of at least one of analytical hardware and controlling software during compliance testing said system comprising a data reduction engine configured to reduce data outputted by an instrument a calculation engine configured to perform at least one calculation on at least one of said reduced data to pro duce one or more outputs required for a set of predefined criteria an automatic detection engine configured to d
54. or 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 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 Optionally criteria such as limits may be set according to a user s needs such as when dual limits are provided for example 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
55. or 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 systems and computer readable media for com pliance testing at least one of instrumentation and software are provided for inputting data from at least one analytical instrument or software performing one or more calculations on the data to produce one or more outputs and selecting from the one or more outputs to populate a final report a 5 35 40 45 50 60 2 wherein the one or more outputs are standardized and are directly comparable to outputs resultant from carrying out the method carried on another set of one or more other analytical instruments irrespective of manufacturer or model of the other analytical instruments Methods systems and computer readable media may com pare at least one of the outputs to first and second test limits and report compliance status of the at least one output relative to the first test limit and to the second test limit Methods systems and computer readable media are pro vided for compliance testing at least one of instrumentation and software by inputting data from at least one analytical instrument or software performing one or more calculations on the inputted data to produce one or more outputs compar ing at least one of th
56. re 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 EZChrom Elite was introduced by Scientific Soft ware Inc While offering a relatively large driver set this solution is still limited by the available drivers that are pro vided 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 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 instruments having different platforms and or still other instruments that aren t included with any established plat forms Accordingly there is a need f
57. ring 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 clarity 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 Anautomated report application automated report genera tor 442 may be optionally included and if used functions to automatically populate documents at event 418 which are then outputted as a customizable report 444 at event 420 Automated report generator 442 is an application that facili tates that co
58. rse 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 systems 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 20 25 30 35 40 45 50 55 60 65 4 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 ofan analytical instrument and or soft ware under consideration with a set of predefined criteria Such predefined criteria may be criteria defined for regulated industries F
59. s of instruments being reported upon and or whether the system is capable of fully automatically obtaining all infor mation 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 406 permits flexible for matting of process For example the process 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 e g see http office microsoft com en us FX010857981033 aspx or other alternative chart building software that 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 user client requires step C to be performed after step A and before step B 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 proce
60. s simply assembled and attached to the forms 200 containing metadata Everything between the raw data e g original data received from an instrument or instrumentation software and the final reported values is considered 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 additional 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 Ininstances wherein BPM 406 is employed 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 Alterna tively the final document may be manually forwarded by a user such as by the user emailing or otherwise forwarding the final document 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 processing the information that is desired to be re evaluated However ifthis is not done then any changes will US 7 890 285 B2 15 still be captured by system 100 or by ECM 404 if used through its automatic audit trails functionality Furt
61. si Aoe1nooy MOL IVI MOL 1U9A OS JO uolsro 1d pue vol Amo 94 JUUAP o 1979uiMo B ISIP pojelqi e E s sn IS stu ZZZ uorsio d pue LoemoIy Moja V JUSA OS NY C NZEZ 00 US 7 890 285 B2 1 SCALABLE INTEGRATED TOOL FOR COMPLIANCE TESTING CROSS REFERENCE This application is a continuation in part application of application Ser No 11 119 255 filed Apr 29 2005 now U S Pat No 7 440 863 which is incorporated herein by reference in its entirety and to which application we claim priority under 35 USC 120 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 instrument using its native controller Examples of proprietary embedded software suites include Cerity NDS Agilent Technologies Inc for chemical pharmaceutical quality assurance and quality control and Empower CDS based on Waters Millenium software Waters Inc These software suites are limited to the suite of instruments that they can control Thus even though these suites a
62. ss management 604 as was described ear lier The technology neutral design of system 100 allows any client s or manufacturer s data system i e Instrument s Data System 606 to be fed into ECM 404 Accordingly any type of instrument model of instrument or manufacturer of an instrument may be included as instruments 612 from which US 7 890 285 B2 11 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 another liquid chromatography gas chro matography instrument 612 produced by a third manufac turer Instrument 4 may be a 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 than one manufacturer vendor Examples of mixed vendor systems include but are not lim itedto a computer data system manufactured by a first vendor and controlling an instrument manufactured by
63. t that various changes may be made and equivalents may be substituted without departing 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 The invention claimed is 1 A computer implemented method of compliance testing said method comprising inputting data from at least one analytical instrument or controlling software of an analytical instrument to a system converting said inputted data of said at least one analytical instrument or said controlling software to a technology neutral format performing one or more calculations on said inputted data using a computer implemented analytical instrument compliance system to produce one or more outputs selecting from said one or more outputs to populate a final report wherein said one or more outputs are standard ized and are directly comparable to outputs resultant from said method carried out on another set of one or more other analytical instruments or controlling soft wares for analytical instruments irrespective of manu facturer or model of said other analytical instruments comparing at least one of said outputs to first and second test limits indicative of said instrument s performance and repor
64. ting compliance status of said at least one output based on said comparing to said first test limit and to said second test limit 2 The method of claim 1 wherein said data is converted to said technology neutral format prior to said inputting 3 The method of claim 1 wherein said data is converted to said technology neutral format after said inputting 4 The method of claim 1 wherein at least one of said first and second test limits is user settable 5 The method of claim 1 wherein one of said first and second test limits is automatically preset 6 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 US 7 890 285 B2 19 same data reduction engine may be used for data received from multiple analytical instruments 7 The method of claim 6 further comprising inputting results of said data reduction to a calculation engine and performing at least one further calculation based upon said inputted results 8 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 said analytical instrument or software under consideration with a set of predefined criteria 9 A computer implemented method of compliance testing said method comprising inputting data from at least one analytical instrument or co
65. tocol 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 cations i e a protocol deviation form The forms may be XML based forms 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 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

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