計算機系統(tǒng)驗證方案

1、ComputerisedSystemValidation計算機系統(tǒng)驗證Dept.部門：EffectiveDate生效日期：Year/Month/月ConfidentialLevel機密等級：Top-secret絕密Confidential機密Cryptical秘密DistributionList?:分發(fā)清單：QA部、QC部、OSP固體制劑部、Lo.物控部、EN工程部、TD技術(shù)部、EQ設(shè)備部QA質(zhì)量保證部1 Objective目的TestandassessmentshouldbetakenforURS,design,purchase,installation,function,aswellasp

2、rocess-adaptability-ofcomputeTZidMan日PLCcontrolsystemrelatedtoGMPincompliancewiththisSOPsoastoensurethatcomputerizedandPLCarefitfordesignrequirementandstatedtechnicalcriteriaandareabletoworkstablyforalongtime.測試、評估采取的URS、設(shè)計、采購、安裝、功能以及計算機控制和PLC控制系統(tǒng)符合GMP，以確保計算機和PLC符合設(shè)計要求和工藝要求并且能夠穩(wěn)定工作很長時間。2 Scope范圍Role

3、責(zé)任人Draft起草人Review審核人Review審核人Review審核人Review審核人Review審核人Review審核人Approve批準(zhǔn)人Dept.部門QAQCOSPLo.ENTDEQQDName姓名Signature簽名Date日期ThisSOPisfitforthevalidationmanagementofcomputerizedandPLCcontrolsystemrelatedtoGMP,whichapplytomaterialcontrolandmanagement,laboratoryequipmentcontrolandcommunicationmanagement

4、,manufacturingprocesscontrol,andutilitiescontrol.本SOP適用于電腦,PLC控制系統(tǒng)的管理是否符合GMP,物料控制和管理，實驗設(shè)備控制和通信管理、生產(chǎn)過程控制、公用設(shè)施的控制的驗證。3 Responsibilities職責(zé)QAisresponsiblefordrafting,revising,reviewing,training,implementingandsupervisingthisSOP.QA負責(zé)起草、修訂、審核、培訓(xùn)、實施和監(jiān)督本SOP。ThequalitydirectorisresponsibleforapprovingthisSOP

5、.質(zhì)量副總負責(zé)批準(zhǔn)本SOP。RelevantdepartmentsareresponsibleforreviewingandimplementingthisSOP。相關(guān)部門負責(zé)審核和實施本SOP。4 Definitions定義ComputerizedorPLCcontrolsystem:Itcomposedofhardware,systemsoftware,applications,andrelevantperipheraldevicesisasystemthatcanimplementafunctionandasetoffunctions.無論是計算機化還是PLC控制系統(tǒng):都是由硬件、系統(tǒng)軟

6、件、應(yīng)用、及相關(guān)的周邊設(shè)備組成的一個系統(tǒng),可以實現(xiàn)某一功能和一套功能。Sourcecode:Itissourceprogramofcomputerwhoseformat(programlanguage)canbereadbyoperator,beforecomputerexecution,itshouldbetranslatetomachinelanguagewhoseformatcanbeexecutedbycomputer.源代碼:它是計算機的源程序(程序語言),可以在電腦執(zhí)行前被計算機識別,它應(yīng)該被翻譯成可以被計算機識別的機器語言。5 Procedures程序5.1 Organizati

7、onofValidationteamandresponsibility5.1.1 驗證機構(gòu)及責(zé)任5.1.2 Validationteamiscomposedofsupplier,QA,EquipmentDepartment,usedepartment.驗證團隊由供應(yīng)商,QA、工程設(shè)備部和使用部門組成。Implementationdepartmentresponsibilityofsystemvalidation系統(tǒng)驗證實施部門的職責(zé) Usedepartment:ResponsibleforprovidingwrittenURS,preparingvalidationprotocolandrep

8、ort,implementingapprovedIQandOQprotocol,completingfinalreportandparticipatingvalidationdeviationinvestigationandalterationreview.使用部門:負責(zé)提供書面的URS,準(zhǔn)備驗證方案和報告、實施批準(zhǔn)IQ,OQ協(xié)議,完成最終報告偏差并參與調(diào)查及變更驗證審核。 EquipmentDepartment:ResponsibleforcooperatingwithusedepartmenttoprepareURSandvalidationprotocol,receivingsystem

9、,installingsystemandimplementingIQ,guidingusedepartmentonIQandOQprocessandparticipatingvalidationdeviationinvestigationandalterationreview. 設(shè)備部門:負責(zé)準(zhǔn)備使用部門的合作協(xié)議,并確認你接收系統(tǒng),安裝系統(tǒng),實施IQ,指導(dǎo)使用部門關(guān)于IQ和0Q的驗證過程和參與驗證偏差調(diào)查和變更回顧。QA:Responsibleforreviewingvalidationdraftandfinalreport,implementingvalidationprotocol,pa

10、rticipatingvalidationdeviationinvestigationandalterationapprovalandarchivingvalidationprotocolandreport.QA：負責(zé)審查驗證，也是最后一項報告草案、實施驗證方案，參與調(diào)查及變更驗證偏差的批準(zhǔn)驗證方案和歸檔,并做好報告。5.2Systemclassification系統(tǒng)分級5.2.1Beforevalidation,evaluationandclassificationshouldbecarriedoutforsystemsoastoinsurethatdifferentgradevalidat

11、ionshouldbeprovidedfordifferenttypecomputerizedandPLCcontrolsystem.Classificationasfollows:在驗證之前,評估和分級應(yīng)當(dāng)進行系統(tǒng)分類,以確保不同等級驗證需提供不同類型的計算機化的,PLC控制系統(tǒng)，分類如下:Classification分類Description描述Validationmethod驗證方法Operatingsystem,network網(wǎng)絡(luò)操作系統(tǒng)，Establishednetworkandoperatingsystemforcommerce.E.g.DOSWindows95/98NT.已做好網(wǎng)

12、絡(luò)和操作系統(tǒng)例如:DOSWindows95/98NT.Validatenameandeditionnumber確認名稱及版本號Standarddevice,microcontroller,sensitiveequipment標(biāo)準(zhǔn)配置，微控制器，靈敏的電氣設(shè)備Thesesystemisdesignedbynon-consumerfordrivingfirmwarewhichcanbeinstalledinspecialintegratecircuit(IC)forapplication,readonlymemory(ROM),randomaccessmemory(RAM),pLcsometime

13、s,suchasbarcodemodem,single-cyclecontroller,fillingdevice,Checkweigher,temperaturecontrolleretc.這些系統(tǒng)是根據(jù)用戶可以安裝在特殊的集成電路(IC)的驅(qū)動固件，只讀存儲器(ROM)、隨機存取存儲器(RAM)、PLC,例如條形碼調(diào)制解調(diào)器,single-cycle控制器、灌裝設(shè)備，重量控制、溫度控制器等來設(shè)計的。Validateconstructionandconfiguration確認構(gòu)造及配置Standardpackage標(biāo)準(zhǔn)程序包Ready-madepackageforcommerce,sucha

14、smultiplansoftware,standardchemicalanalysissoftwareetc.現(xiàn)成的軟件包，例如多計劃軟件，標(biāo)準(zhǔn)化學(xué)分析軟件等。Validateapplicationprocess驗證應(yīng)用過程Configurablepackage可配置的程序包Usersdeveloptheirownapplicationthroughpre-definitesoftwaremodulesanddevelopingapplicationmodulescanbecarriedoutinthissystem,suchasman-machinedialogueport,manageme

15、ntcontrol,dataacquisitionAuditsupplierandvalidateapplicationprocessandsystem,adaptivecontrolsystemforlaboratory,informationmanagementsystemforlaboratory,materialrequirementplanningsystem,dataprocessingsystemforsystem/applicationandproduct,partPLCetc.用戶自己開發(fā)應(yīng)用可通過pre-definite軟件模塊和發(fā)展應(yīng)用模塊都可以在這個系統(tǒng)中運行，采用人機

16、對話端口，管理控制,數(shù)據(jù)采集系統(tǒng)，自適應(yīng)控制系統(tǒng),信息管理系統(tǒng)，原材料需求計劃系統(tǒng)、數(shù)據(jù)處理系統(tǒng)和產(chǎn)品、系統(tǒng)應(yīng)用部分可編程序控制器(PLC)等。somepreestablishedcodeSystemdevelopedwithinfirm公司內(nèi)部系統(tǒng)開發(fā)Modifyingordevelopingsystemincomplianeewithrequirementofhimself修改或開發(fā)符合自己要求的系統(tǒng)ImplementallvalidationprocessesofcomputerizedandPLCcontrolsystem實施計算機及PLC控制系統(tǒng)驗證的全過程.35.3

17、5.3.1SomecomputerizedandPLCcontrolsystemwithcomplexconstructionshouldbeclassifiedinaccordancewithdevelopingdegreeofeachmodule.一些計算機化的和PLC控制系統(tǒng)復(fù)雜程度應(yīng)當(dāng)跟各分類模塊的開發(fā)程度相一致。ValidationofcomputerizedandPLCcontrolsystemshouldbecarriedoutnotonlyforuseprocessofsystem,e.g.validationofnewsystemshouldbecarriedoutnoton

18、lyforinitialdefinitionanddesigningphasebutalsowholelifecycleofsystemdevelopment.計算機驗證,PLC控制系統(tǒng)不僅體現(xiàn)在系統(tǒng)使用過程，如新系統(tǒng)的驗證不僅在初始定義和設(shè)計階段進行,而且貫穿于全部生命周期體系的發(fā)展。Validationimplementation驗證實施URSURSshouldbepreparedbysystemuserandprojectexpertdetailedwithfundamentalrequirement,expectationandperformanceindexofnew/changed

19、computerizedandPLCcontrolsystem,whichwillbeusetodeterminesystemdesigningcriteria.Contentasfollow:URS應(yīng)該為系統(tǒng)用戶和項目專家準(zhǔn)備基本要求詳細的,預(yù)期和新的性能指標(biāo)、更改計算機化和PLC控制系統(tǒng),可以用來決定系統(tǒng)設(shè)計標(biāo)準(zhǔn)。內(nèi)容如下：Systemdescription:whattodoaboutsystem,howconnectionandinteractionbetweendifferentmodule,controlmethods(e.g.logiccontrol,separationcontr

20、ol,interlockcontrol,alarmcontrol,locationcontrol,temperaturecontrol,pressurecontrol,timecontrol,countingandothermultipolarcontrol),implementingprocess,portsandsafetyrequirementforoperator.系統(tǒng)描述:系統(tǒng)做到什么程度,如何關(guān)聯(lián)不同模塊、控制方法(例如:邏輯控制、分離控制,連鎖控制、報警控制、位置控制,溫度控制,壓力控制、時間控制、計數(shù)和其他多級控制)、實施流程、操作員的端口和安全標(biāo)準(zhǔn)。Physicalrequi

21、rement:includesufficientspace,location,peripheralenvironment,etc.物理要求:包括有足夠的空間,位置,周邊環(huán)境等。Documentcriteriaforhardware:includechartpaper,schematicchart,handbook,sparepartslistetc.硬件的文件標(biāo)準(zhǔn):包括:圖紙,原理圖,操作指南,備件清單等。Documentcriteriaforsoftware:includeprogramnumberandrevisingnumber,outputprogramanddetailedexpla

22、nation,reproductionofsoftwareprovisionandretentioncondition,systemblockdrawingandconfigurationlist.軟件的文件標(biāo)準(zhǔn):包括程序編號和修改編號,輸出接口程序和詳細說明、軟件的追加和保留條件、系統(tǒng)分程序圖紙和配置清單。Testrequirement:testitemsandrecordrequiredtobecarriedoutonsystemdevelopingprocess,includingmoduleseparatedtestandintegratedtest.測試要求:測試項目和記錄必須在系統(tǒng)

23、的發(fā)展過程中進行,包括模塊測試和集成分離測試。Otherrequirementtosupplier:suchasfinishedsystemvalidation,qualitycontrolandchangecontrolondevelopingprocess,etc.對供應(yīng)商的其他要求:如在發(fā)展進程中完成系統(tǒng)驗證、質(zhì)量控制和變更控制等。Systemdesign系統(tǒng)設(shè)計Systemdesignshouldcomposeofsystemconfigurablechartdesign,hardwaredesign,andsoftwaredesign.Afterdocumentofsystemdes

24、ignreviewedandapprovedbyconsumerwhichshouldbepreparedbysupplier,systemconfigurablechartdesignshouldbecarriedout,includingsystemPID(processandinstrument),I/O(input/output)connectiondiagram,controlelementparetodiagram.系統(tǒng)設(shè)計應(yīng)該由系統(tǒng)配置圖、硬件設(shè)計和軟件設(shè)計組成。在供應(yīng)商準(zhǔn)備的系統(tǒng)設(shè)計被用戶評估和檢驗后，可配置的系統(tǒng)圖紙設(shè)計應(yīng)該完成,包括系統(tǒng)PID,I/O(輸入/輸出)連接圖、連

25、接原理帕累托圖。Hardwaredesign:includeallI/O(input/output)connectiontemplateandtype,CPUselection,communicationtemplate,man-machineInterfacecontroller,screenviewerselection,mediumrelay,memory,printer,auxiliarypowerunit,electronicelement/wire/cable,otherelementsetc..

26、.2硬件設(shè)計:包括所有I/O(輸入/輸出)連接模板和類型,CPU選型，通信模板、人機界面控制器,屏幕查看選擇、中繼電器、記憶存儲器、打印機、輔助動力裝置,電子部件/電線/電纜、其他元件等。5.3.2. Software:includesystemsoftware,application,anddata.3軟件:包括系統(tǒng)軟件、應(yīng)用和數(shù)據(jù)。5.3.3IQIQshouldbecarriedouttoensurethatsysteminstallationisfitfordesigncriteriaandneededtechnicaldatashouldbecompletelyprov

27、ided.Specialcontentasfollow:IQ應(yīng)該確保該系統(tǒng)安裝符合設(shè)計標(biāo)準(zhǔn)和工藝需求，數(shù)據(jù)完全提供。特殊內(nèi)容如下:5.3.3. Documentqualificationshouldconsistofconsumertechnicalguide,SOP,1trainingplan,post-saleserviceagreement,equipmentinventory,securityprogram,hardwarequalification,softwarequalification,sourcecode,instrumentlist,instrumentcalibratio

28、nprocedure,PID,controlloopdiagram,I/O(input/output)devicelistandconnectiondiagram,sparepartslist,andmaintenanceprocedure.文件確認應(yīng)該由用戶工藝要求、SOP,培訓(xùn)計劃,售后服務(wù)協(xié)議、設(shè)備庫存，安全程序、硬件說明，軟件說明,源代碼、儀器清單、儀器校準(zhǔn)程序、PID、控制回路圖,1/0(輸入/輸出設(shè)備清單和連接圖，備件清單和維護規(guī)程。5.3.3. Installationprocessqualification:qualifythatinstallationisfitforrequ

29、irement2 PIDandoperatingmanual.安裝過程說明:安裝符合PID和操作手冊的要求。5.3.3. Circumstanceandutilitiesqualification3 事件和實用程序說明(1) Qualifyandrecordcircumstanceofsysteminstallation,suchascleanlevel,radiofrequency/electromagneticinterference,physicalprotection,temperature,humility,sound,lighting,etc.系統(tǒng)安裝環(huán)境的檢驗和記錄:例如潔凈水平

30、、射頻/電磁干擾、物理保護、溫度、濕度、聲音、照明等。(2) Recordconditionofcriticalutilitiesandqualifythatcriticalnatureofutilitiesshouldbefitforinstructionincludingfirealarmannouncement/prevention,coolingsystem,electricpoweranditsadjustment,continuouspowersupply,wideareanetworkconnection,localareanetworkconnection,disasterre

31、covery,telephonefigure/analog,etc.記錄關(guān)鍵設(shè)施以及條件,鑒定的公共設(shè)施應(yīng)該跟說明一致:包括消防報警公告/預(yù)防系統(tǒng)、冷卻系統(tǒng)、電力及調(diào)整,持續(xù)供電、大面積網(wǎng)絡(luò)連接,本地區(qū)域網(wǎng)絡(luò)連接,災(zāi)難恢復(fù)、電話圖形/模擬等(3) Qualifythatrecordsystemisfitforrequirementofman-machineengineer.條件和記錄系統(tǒng)符合人控機工程師的要求。5.3.3. Systemtestandqualification4 系統(tǒng)測試、條件(1) ThefirststeptodoistoqualifythatreportitemsofFAT

32、(factoryacceptancetest)shouldbecompletelysuppliedbysupplierandfitfordesigncriteria.第一步要做的是,報告項目FAT的驗收測試應(yīng)該完全由供應(yīng)商提供,適用于設(shè)計標(biāo)準(zhǔn)。(2) Necessarytestshouldbecarriedoutforsystemonoperationalcircumstance.Essentialcontentasfollow:應(yīng)該對系統(tǒng)運行情況開展必要的測試。基本內(nèi)容如下:5.3.4 Allinstrumentsandmetersshouldbecalibratedandonexpired

33、ayofcalibration.Calibrationshouldbefitfordefinitecriteriaandcorrespondingcertificationshouldbeprovided.所有儀器儀表應(yīng)該被校準(zhǔn)和標(biāo)注過期日，校準(zhǔn)應(yīng)該有明確的標(biāo)準(zhǔn)及應(yīng)提供相應(yīng)的檢查證件。 I/O(input/output)signaltestshouldbecarriedoutsoastoensurethatsinglecantransmitfromcontrolsystemtodeviceandreturn.I/O(輸入/輸出)信號試驗應(yīng)確保信號可以在控制系統(tǒng)設(shè)備間進行傳輸和反饋。 Dataa

34、cquisitionandtransmissionandsignalmemorytest數(shù)據(jù)采集,傳送和信號記憶測試 Othertests?其他測試OQ(operationqualification)運行確認ThepurposeofOQisthatallfunctiontestsshouldbecarriedoutonoperationalcircumstancesoastoensurethatsystemandoperationshouldbefitfordesigncriteria.Contentasfollow;OQ的目的是進行所有功能運行情況方面的測試以確保系統(tǒng)和運行符合設(shè)計標(biāo)準(zhǔn)，內(nèi)容

35、如下：Testforsystemsecurity:“worstcase”ofalllogicsystemsshouldbetested,e.g.useauthorityofdifferentpersonsshouldbetestedsoastoidentifythatoperationunauthorizedshouldbeforbidden.測試系統(tǒng)安全:“最壞情況”的系統(tǒng)邏輯應(yīng)該進行測試,如使用不同權(quán)限以便確認未經(jīng)授權(quán)運行是否被禁止。Variousprocessescontrolfunctiontestsrequiredbysystemrequest:“worstcase“(

36、e.g.maximumcommunicationload,processofconsiderabledatadocument,etc.)testforallfunctionofsystemanddecisionroutinesshouldbecarriedoutinaccordancewithvariousrequirementsandcriteriasuppliedbysystemdefinition.(Itisimportantthatafunctionaldiagramincludingallbranchroutinesshouldbeprovided.)根據(jù)系統(tǒng)要求進行的各種各樣的過程

37、控制功能的測試:“最壞情況”(例如最大通信承載、過程相當(dāng)大的數(shù)據(jù)文件等)試驗檢查系統(tǒng)和決策程序的功能,應(yīng)根據(jù)系統(tǒng)不同的要求和標(biāo)準(zhǔn)提供的定義。（提供功能圖表包括所有出現(xiàn)的偏差是非常重要的。）Testforalarmandinterlock:efficacyofcorrespondingprogramshouldbetestedontheconditionofalarmandinterlockforsysteminaccordancewithsystemoperationmanual.檢測報警及連鎖:程序連鎖應(yīng)根據(jù)報警條件及系統(tǒng)連鎖操作手冊進行測試。Testfortimerandsequencer

38、:establishtimeandprogramofsystemgeneratingcorrespondingfunctionaccordingtosystemoperationmanualsoastovalidateefficacyofsystemtimingororderingprogram.定時器和定序器測試:根據(jù)系統(tǒng)的操作手冊設(shè)置時間和系統(tǒng)產(chǎn)生相應(yīng)的功能以確認系統(tǒng)有效時間或程序命令Testfordatadisposalandmemory測試數(shù)據(jù)處理和記憶(1) Qualifycorrectdatamemory,collectionandsearchofsystem'own.正確

39、的數(shù)據(jù)記憶,準(zhǔn)確的數(shù)據(jù)采集和系統(tǒng)的自我搜索的確認。(2) Qualifydisposalofdataoutputlength,carryandempty數(shù)據(jù)處理的輸出長度、承載和空載的確認(3) Qualifythefunctionofsavingdatatocorrespondingfolder.數(shù)據(jù)保存到相應(yīng)文件夾的功能確認。Testforshutdown/recovery關(guān)機/恢復(fù)測試5.3.4. (1)Checkconditionofthedataacquisitionbeforeandaftershutdownsoasto6 ensurethatdatahavenotbeendama

40、gedorlost.在系統(tǒng)關(guān)閉之前和之后檢查數(shù)據(jù)采集的情況,確保數(shù)據(jù)沒有損壞或丟失。(2) Checkthefunctionofbackuppowersupply,uninterruptiblepowersupply,poweradjusterandpowergenerator.檢查備用電源的供應(yīng)、不間斷電源供應(yīng)器、電力調(diào)節(jié)器和電力發(fā)電機。(3) Systembreakdownsorfailuresshouldbemadeinaccordancewithsystemoperationmanualsoastoensurethatback-upsystemshouldbeprovided.系統(tǒng)故障

41、和失敗的時候,能夠根據(jù)系統(tǒng)的操作手冊提供系統(tǒng)備份。Otherfunctiontest其他功能測試5.3.4. Performancequalification(PQ)7 性能確認5.3.5 ThepurposeofPQisthatqualifytheefficacyandstabilityofrunningprocessonoperationalcircumstance.Testitemsshouldbeestablishedinaccordancewithachievingdesiredresultandduplicatequalificationshouldbealsocarriedout

42、.PQ的目的是確認系統(tǒng)運行過程中的有效性和穩(wěn)定性方面的情況。測試項目應(yīng)確定跟期望達到的結(jié)果相一致、二次確認也應(yīng)該執(zhí)行。Ifsystemispartofproduction,laboratoryorutilities,PQofsystemshouldbecompletedconformitywithPQofequipment(utilities).如果系統(tǒng)是生產(chǎn),實驗室或公共設(shè)施系統(tǒng)的一部分,系統(tǒng)的PQ必須根據(jù)設(shè)備的PQ進行完整性測試。5.3.5. IfamanualsystemisbeingreplacedbycomputerizedandPLCcontrol1system,thetwosho

43、uldberuninparallel.當(dāng)一個人工系統(tǒng)被電腦,PLC控制系統(tǒng)取代時,兩者需要平行運行。5.3.5. Regardingtoproductionequipment,thetestforproductspecification,suchas2assay,testforpackagingspecification,etc,shouldbecarriedoutsoastoensurethattheallprocesscontrolfunctionsareeffective.Testsshouldbecarriedoutforatleast3consecutivebatchesonthes

44、omeproductioncondition.對于生產(chǎn)設(shè)備,要進行產(chǎn)品規(guī)格測試,如化驗、包裝規(guī)格測試等等,確保所有的過程控制功能都是有效的，應(yīng)當(dāng)在相同的生產(chǎn)的條件下進行至少3個連續(xù)批次的測試。Monitoringforequipmentofconsecutiveprocessdisposalshouldbecarriedout,e.g.indexofclean-airsystem,suchasdustparticle,microorganism,temperature,humidity,airflow,pressuredifference,airexchangefrequency,etc,sh

45、ouldbemonitoredduringaperiod.對設(shè)備的連續(xù)過程進行監(jiān)控應(yīng)當(dāng)進行,如空氣凈化體系的指標(biāo),例如塵埃粒子、微生物、溫度、濕度、風(fēng)量、壓差、換氣頻率等,應(yīng)在一個周期內(nèi)被監(jiān)控。Validationdeviation偏差驗證5.3.6 Thedisposalofsystemvalidationdeviationcanreferto<ValidationOrganizationandImplementation>.處置系統(tǒng)偏差驗證可參閱驗證組織和實施。Changecontrol變更控制5.3.7 Changeclassification:changeiscomposedofhardwarechange,softwarechangeandchangeofcriticalparametersindatabase.變更的分類:變更是由硬件變更、軟件變更，和數(shù)據(jù)庫的臨界參數(shù)變更組成。Ifchangeoccurring,changecontrolshouldbecarriedouts