計算機系統(tǒng)驗證方案

1、ComputerisedSystemValidation計算機系統(tǒng)驗證Dept.部門：QA/質(zhì)量保證部EffectiveDate生效日期：Year/年Month/月Date/日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Role責任人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批準人Dept.部門QAQ

2、COSPLo.ENTDEQQDName姓名Signature簽名Date日期Objective目的TestandassessmentshouldbetakenforURS,design,purchase,installation,function,aswellasprocessadaptabilityofcomputerizedandPLCcontrolsystemrelatedtoGMPincompliancewiththisSOPsoastoensurethatcomputerizedandPLCarefitfordesignrequirementandstatedtechnicalcri

3、teriaandareabletoworkstablyforalongtime.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ThisSOPisfitforthevalidationmanagementofcomputerizedandPLCcontrolsystemrelatedtoGMP,whichapplytomaterialcontrolandmanagement,laboratoryequipmentcontrolandcommunicationmanage

4、ment,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QAisresponsiblefordrafting,revising,reviewing,training,implementingandsupervisingthisSOP.QA負責起草、修訂、審核、培訓、實施和監(jiān)督本SOP。Thequalitydirectorisresponsibleforapprovingthi

5、sSOP.質(zhì)量副總負責批準本SOP。RelevantdepartmentsareresponsibleforreviewingandimplementingthisSOP。相關(guān)部門負責審核和實施本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

6、、系統(tǒng)軟件、應用、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,它應該被翻譯成可以被計算機識別的機器語言。5 Procedures程序ofValidati

7、onteamandresponsibility驗證機構(gòu)及責任Validationteamiscomposedofsupplier,QA,EquipmentDepartment,usedepartment.驗證團隊由供應商,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Usedepartment:ResponsibleforprovidingwrittenURS,preparingvalidationprotocolandreport,implementingapprovedI

8、QandOQprotocol,completingfinalreportandparticipatingvalidationdeviationinvestigationandalterationreview.使用部門：負責提供書面的URS,準備驗證方案和報告、實施批準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,installingsystemandimplem

9、entingIQ,guidingusedepartmentonIQandOQprocessandparticipatingvalidationdeviationinvestigationandalterationreview.設(shè)備部門：負責準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,指導使用部門關(guān)于IQ和OQ的驗證過程和參與驗證偏差調(diào)查和變更回顧。QA:Responsibleforreviewingvalidationdraftandfinalreport,implementingvalidationprotocol,participatingvalidationdeviat

10、ioninvestigationandalterationapprovalandarchivingvalidationprotocolandreport.QA:負責審查驗證，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驗證方案和歸檔，并做好報告。Systemclassification系統(tǒng)分級validation,evaluationandclassificationshouldbecarriedoutforsystemsoastoinsurethatdifferentgradevalidationshouldbeprovidedfordifferenttypecomput

11、erizedandPLCcontrolsystem.Classificationasfollows:在驗證之前，評估和分級應當進行系統(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)絡操作系統(tǒng)，Establishednetworkandoperatingsystemforcommerce.DOSWindows95/98NT.已做好網(wǎng)絡和操作系統(tǒng)例如：DOSWindows95/98NT.Validatenameandedi

12、tionnumber確認名稱及版本號Standarddevice,microcontroller,sensitiveequipment標準配置，微控制器，靈敏的電氣設(shè)備Thesesystemisdesignedbynon-consumerfordrivingfirmwarewhichcanbeinstalledinspecialintegratecircuit(IC)forapplication,readonlymemory(ROM),randomaccessmemory(RAM),PLCsometimes,suchasbarcodemodem,single-cyclecontroller,f

13、illingdevice,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、溫度控制器等乘設(shè)計的。Validateconstructionandconfiguration確認構(gòu)造及配置Standardpackage標準程序包Ready-madepackageforcommerce,suchasmultiplansoftware,standardchemicalanalysisso

14、ftwareetc.現(xiàn)成的軟件包，例如多計劃軟件，標準化學分析軟件等。Validateapplicationprocess驗證應用過程ConfigurablepackageUsersdeveloptheirownapplicationthroughpre-definitesoftwaremodulesanddevelopingAuditsupplierandvalidate口配置的程序包applicationmodulescanbecarriedoutinthissystem,suchasman-machinedialogueport,managementcontrol,dataacquisi

15、tionsystem,adaptivecontrolsystemforlaboratory,informationmanagementsystemforlaboratory,materialrequirementplanningsystem,dataprocessingsystemforsystem/applicationandproduct,partPLCetc.用戶自己開發(fā)應用可通過pre-definite軟件模塊和發(fā)展應用模塊都可以在這個系統(tǒng)中運行，采用人機對話端口，管理控制，數(shù)據(jù)采集系統(tǒng)，自適應控制系統(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)應用部分可編程序控制器(

16、PLC)等。applicationprocessandsomepreestablishedcodeSystemdevelopedwithinfirm公司內(nèi)部系統(tǒng)開發(fā)Modifyingordevelopingsystemincompliancewithrequirementofhimself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computerizedandPLCcontrolsystemwithcomplexconstructionshou

17、ldbeclassifiedinaccordancewithdevelopingdegreeofeachmodule.一些計算機化的和PLC控制系統(tǒng)復雜程度應當跟各分類模塊的開發(fā)程度相一致。ofcomputerizedandPLCcontrolsystemshouldbecarriedoutnotonlyforuseprocessofsystem,.validationofnewsystemshouldbecarriedoutnotonlyforinitialdefinitionanddesigningphasebutalsowholelifecycleofsystemdevelopment.

18、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5.3.1 URSURSshouldbepreparedbysystemuserandprojectexpertdetailedwithfundamentalrequirement,expectationandperformanceindexofnew/changedcomputerizedandPLCcontrolsystem,whichwillbeusetodeterminesystemdesigningcr

19、iteria.Contentasfollow:URS應該為系統(tǒng)用戶和項目專家準備基本要求詳細的，預期和新的性能指標、更改計算機化和PLC控制系統(tǒng)，可以用來決定系統(tǒng)設(shè)計標準。內(nèi)容如下：description:whattodoaboutsystem,howconnectionandinteractionbetweendifferentmodule,controlmethods.logiccontrol,separationcontrol,interlockcontrol,alarmcontrol,locationcontrol,temperaturecontrol,pressurecontrol,

20、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準。 Physicalrequirement:includesufficientspace,location,peripheralenvironment,etc.物理要求:包括有足夠的

21、空間,位置,周邊環(huán)境等。 Documentcriteriaforhardware:includechartpaper,schematicchart,handbook,sparepartslistetc.硬件的文件標準:包括:圖紙,原理圖,操作指南,備件清單等。 Documentcriteriaforsoftware:includeprogramnumberandrevisingnumber,outputprogramanddetailedexplanation,reproductionofsoftwareprovisionandretentioncondition,

22、systemblockdrawingandconfigurationlist.軟件的文件標準: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)的發(fā)展過程中進行,包括模塊測試和集成分離測試。 Otherrequirementtosup

23、plier:suchasfinishedsystemvalidation,qualitycontrolandchangecontrolondevelopingprocess,etc.對供應商的其他要求: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。5.3.2 Systemdesign系統(tǒng)設(shè)計 Systemdesignshouldcomposeofsystemconfigurablechartdesign,hardwaredesign,andsoftwaredesign.Afterdocumentofsystemdesignreviewedandapprovedbyconsum

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

25、:includeallI/O(input/output)connectiontemplateandtype,CPUselection,communicationtemplate,man-machineInterfacecontroller,screenviewerselection,mediumrelay,memory,printer,auxiliarypowerunit,electronicelement/wire/cableotherelementsetc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、

26、輔助動力裝置,電子部件/電線/電纜、其他元件等。 Software:includesystemsoftware,application,anddata.軟件:包括系統(tǒng)軟件、應用和數(shù)據(jù)。.3IQIQshouldbecarriedouttoensurethatsysteminstallationisfitfordesigncriteriaandneededtechnicaldatashouldbecompletelyprovided.Specialcontentasfollow:IQ應該確保該系統(tǒng)安裝符合設(shè)計標準和工藝需求，數(shù)據(jù)完全提供。特殊內(nèi)容如下: Document

27、qualificationshouldconsistofconsumertechnicalguide,SOP,trainingplan,post-saleserviceagreement,equipmentinventory,securityprogram,hardwarequalification,softwarequalification,sourcecode,instrumentlist,instrumentcalibrationprocedure,PID,controlloopdiagram,I/O(input/output)devicelistandconnectiondiagram

28、,sparepartslist,andmaintenanceprocedure.文件確認應該由用戶工藝要求、SOP,培訓計劃,售后服務協(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。 Installationprocessqualification:qualifythatinstallationisfitforrequirementPIDandoperatingmanual.安裝過程說明:安裝符合PID和操作手冊的要求。 Circumstanceandutili

29、tiesqualification.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、射頻/電磁干擾、物理保護、溫度、濕度、聲音、照明等。(2) Recordconditionofcriticalutilitiesandqualifythatcri

30、ticalnatureofutilitiesshouldbefitforinstructionincludingfirealarmannouncement/prevention,coolingsystem,electricpoweranditsadjustment,continuouspowersupply,wideareanetworkconnection,localareanetworkconnection,disasterrecovery,telephonefigure/analog,etc.記錄關(guān)鍵設(shè)施以及條件,鑒定的公共設(shè)施應該跟說明一致:包括消防報警公告/預防系統(tǒng)、冷卻系統(tǒng)、電力及

31、調(diào)整,持續(xù)供電、大面積網(wǎng)絡連接,本地區(qū)域網(wǎng)絡連接,災難恢復、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。 Systemtestandqualification系統(tǒng)測試、條件(1) ThefirststeptodoistoqualifythatreportitemsofFAT(factoryacceptancetest)shouldbecompletelysuppliedbysupplierandfitfordesigncriteria.

32、第一步要做的是,報告項目FAT的驗收測試應該完全由供應商提供,適用于設(shè)計標準。(2) Necessarytestshouldbecarriedoutforsystemonoperationalcircumstance.Essentialcontentasfollow:應該對系統(tǒng)運行情況開展必要的測試?；緝?nèi)容如下:instrumentsandmetersshouldbecalibratedandonexpiredayofcalibration.Calibrationshouldbefitfordefinitecriteriaandcorrespondingcertificationshould

33、beprovided.所有儀器儀表應該被校準和標注過期日，校準應該有明確的標準及應提供相應的檢查證件。I/0(input/output)signaltestshouldbecarriedoutsoastoensurethatsinglecantransmitfromcontrolsystemtodeviceandreturn.I/0(輸入/輸出)信號試驗應確保信號可以在控制系統(tǒng)設(shè)備間進行傳輸和反饋。Dataacquisitionandtransmissionandsignalmemorytest數(shù)據(jù)采集,傳送和信號記憶測試0thertests?其他測試0Q(operationqualifica

34、tion)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)計標準，內(nèi)容如下：Testforsystemsecurity:"worstcase"ofalllogicsystemsshouldbetested,.useauthor

35、ityofdifferentpersonsshouldbetestedsoastoidentifythatoperationunauthorizedshouldbeforbidden.測試系統(tǒng)安全：“最壞情況”的系統(tǒng)邏輯應該進行測試，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。processescontrolfunctiontestsrequiredbysystemrequest:"worstcase“(.maximumcommunicationload,processofconsiderabledatadocument,etc.)testforallfunctionofsyste

36、manddecisionroutinesshouldbecarriedoutinaccordancewithvariousrequirementsandcriteriasuppliedbysystemdefinition.(Itisimportantthatafunctionaldiagramincludingallbranchroutinesshouldbeprovided.)根據(jù)系統(tǒng)要求進行的各種各樣的過程控制功能的測試：“最壞情況”(例如最大通信承載、過程相當大的數(shù)據(jù)文件等)試驗檢查系統(tǒng)和決策程序的功能，應根據(jù)系統(tǒng)不同的要求和標準提供的定義。(提供功能圖表包括所有出現(xiàn)的偏差是非常重要的。

37、)foralarmandinterlock:efficacyofcorrespondingprogramshouldbetestedontheconditionofalarmandinterlockforsysteminaccordancewithsystemoperationmanual.檢測報警及連鎖：程序連鎖應根據(jù)報警條件及系統(tǒng)連鎖操作手冊進行測試。fortimerandsequencer:establishtimeandprogramofsystemgeneratingcorrespondingfunctionaccordingtosystemoperationmanualsoasto

38、validateefficacyofsystemtimingororderingprogram.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)生相應的功能以確認系統(tǒng)有效時間或程序命令fordatadisposalandmemory測試數(shù)據(jù)處理和記憶(1) Qualifycorrectdatamemory,collectionandsearchofsystemsown.正確的數(shù)據(jù)記憶，準確的數(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) Qualifythef

39、unctionofsavingdatatocorrespondingfolder.數(shù)據(jù)保存到相應文件夾的功能確認。Testforshutdown/recovery關(guān)機/恢復測試2 .3.4.6(1)Checkconditionofthedataacquisitionbeforeandaftershutdownsoastoensurethatdatahavenotbeendamagedorlost.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,po

40、weradjusterandpowergenerator.檢查備用電源的供應、不間斷電源供應器、電力調(diào)節(jié)器和電力發(fā)電機。(3)Systembreakdownsorfailuresshouldbemadeinaccordancewithsystemoperationmanualsoastoensurethatback-upsystemshouldbeprovided.系統(tǒng)故障和失敗的時候，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 347Performancequalification(PQ)性能確認5.3.5ThepurposeofPQisthatqu

41、alifytheefficacyandstabilityofrunningprocessonoperationalcircumstance.Testitemsshouldbeestablishedinaccordancewithachievingdesiredresultandduplicatequalificationshouldbealsocarriedout.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。測試項目應確定跟期望達到的結(jié)果相一致、二次確認也應該執(zhí)行。Ifsystemispartofproduction,laboratoryorutilities,PQofsyste

42、mshouldbecompletedconformitywithPQofequipment(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。 IfamanualsystemisbeingreplacedbycomputerizedandPLCcontrolsystem,thetwoshouldberuninparallel.當一個人工系統(tǒng)被電腦,PLC控制系統(tǒng)取代時，兩者需要平行運行。 Regardingtoproductionequipment,thetestforproductspecificati

43、on,suchasassay,testforpackagingspecification,etc,shouldbecarriedoutsoastoensurethattheallprocesscontrolfunctionsareeffective.Testsshouldbecarriedoutforatleast3consecutivebatchesonthesomeproductioncondition.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，應當在相同的生產(chǎn)的條件下進行至少3個連續(xù)批次的測試。forequipmentofconsecu

44、tiveprocessdisposalshouldbecarriedout,.indexofclean-airsystem,suchasdustparticle,microorganism,temperature,humidity,airflow,pressuredifference,airexchangefrequency,etc,shouldbemonitoredduringaperiod.對設(shè)備的連續(xù)過程進行監(jiān)控應當進行,如空氣凈化體系的指標,例如塵埃粒子、微生物、溫度、濕度、風量、壓差、換氣頻率等,應在一個周期內(nèi)被監(jiān)控。deviation偏差驗證disposalofsystemvali

45、dationdeviationcanreferto<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classification: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。changeoccurring,changecontrolshouldbecarriedoutsoastoensuret