1、ComputerisedSystemValidation計算機系統驗證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?:分發清單：QA部、QC部、OSP固體制劑部、Lo.物控部、EN工程部、TD技術部、EQ設備部QA質量保證部1 Objective目的TestandassessmentshouldbetakenforURS,design,purchase,installation,function,aswellasp

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

3、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控制系統的管理是否符合GMP,物料控制和管理，實驗設備控制和通信管理、生產過程控制、公用設施的控制的驗證。3 Responsibilities職責QAisresponsiblefordrafting,revising,reviewing,training,implementingandsupervisingthisSOP.QA負責起草、修訂、審核、培訓、實施和監督本SOP。ThequalitydirectorisresponsibleforapprovingthisSOP

5、.質量副總負責批準本SOP。RelevantdepartmentsareresponsibleforreviewingandimplementingthisSOP。相關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:都是由硬件、系統軟

6、件、應用、及相關的周邊設備組成的一個系統,可以實現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5.1 Organizati

7、onofValidationteamandresponsibility5.1.1 驗證機構及責任5.1.2 Validationteamiscomposedofsupplier,QA,EquipmentDepartment,usedepartment.驗證團隊由供應商,QA、工程設備部和使用部門組成。Implementationdepartmentresponsibilityofsystemvalidation系統驗證實施部門的職責 Usedepartment:ResponsibleforprovidingwrittenURS,preparingvalidationprotocolandrep

8、ort,implementingapprovedIQandOQprotocol,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協議,完成最終報告偏差并參與調查及變更驗證審核。 EquipmentDepartment:ResponsibleforcooperatingwithusedepartmenttoprepareURSandvalidationprotocol,receivingsystem

9、,installingsystemandimplementingIQ,guidingusedepartmentonIQandOQprocessandparticipatingvalidationdeviationinvestigationandalterationreview. 設備部門:負責準備使用部門的合作協議,并確認你接收系統,安裝系統,實施IQ,指導使用部門關于IQ和0Q的驗證過程和參與驗證偏差調查和變更回顧。QA:Responsibleforreviewingvalidationdraftandfinalreport,implementingvalidationprotocol,pa

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

11、ionshouldbeprovidedfordifferenttypecomputerizedandPLCcontrolsystem.Classificationasfollows:在驗證之前,評估和分級應當進行系統分類,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，分類如下:Classification分類Description描述Validationmethod驗證方法Operatingsystem,network網絡操作系統，Establishednetworkandoperatingsystemforcommerce.E.g.DOSWindows95/98NT.已做好網

12、絡和操作系統例如:DOSWindows95/98NT.Validatenameandeditionnumber確認名稱及版本號Standarddevice,microcontroller,sensitiveequipment標準配置，微控制器，靈敏的電氣設備Thesesystemisdesignedbynon-consumerfordrivingfirmwarewhichcanbeinstalledinspecialintegratecircuit(IC)forapplication,readonlymemory(ROM),randomaccessmemory(RAM),pLcsometime

13、s,suchasbarcodemodem,single-cyclecontroller,fillingdevice,Checkweigher,temperaturecontrolleretc.這些系統是根據用戶可以安裝在特殊的集成電路(IC)的驅動固件，只讀存儲器(ROM)、隨機存取存儲器(RAM)、PLC,例如條形碼調制解調器,single-cycle控制器、灌裝設備，重量控制、溫度控制器等來設計的。Validateconstructionandconfiguration確認構造及配置Standardpackage標準程序包Ready-madepackageforcommerce,sucha

14、smultiplansoftware,standardchemicalanalysissoftwareetc.現成的軟件包，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.用戶自己開發應用可通過pre-definite軟件模塊和發展應用模塊都可以在這個系統中運行，采用人機

16、對話端口，管理控制,數據采集系統，自適應控制系統,信息管理系統，原材料需求計劃系統、數據處理系統和產品、系統應用部分可編程序控制器(PLC)等。somepreestablishedcodeSystemdevelopedwithinfirm公司內部系統開發Modifyingordevelopingsystemincomplianeewithrequirementofhimself修改或開發符合自己要求的系統ImplementallvalidationprocessesofcomputerizedandPLCcontrolsystem實施計算機及PLC控制系統驗證的全過程.35.3

17、5.3.1SomecomputerizedandPLCcontrolsystemwithcomplexconstructionshouldbeclassifiedinaccordancewithdevelopingdegreeofeachmodule.一些計算機化的和PLC控制系統復雜程度應當跟各分類模塊的開發程度相一致。ValidationofcomputerizedandPLCcontrolsystemshouldbecarriedoutnotonlyforuseprocessofsystem,e.g.validationofnewsystemshouldbecarriedoutnoton

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

19、computerizedandPLCcontrolsystem,whichwillbeusetodeterminesystemdesigningcriteria.Contentasfollow:URS應該為系統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,可以用來決定系統設計標準。內容如下：Systemdescription:whattodoaboutsystem,howconnectionandinteractionbetweendifferentmodule,controlmethods(e.g.logiccontrol,separationcontr

20、ol,interlockcontrol,alarmcontrol,locationcontrol,temperaturecontrol,pressurecontrol,timecontrol,countingandothermultipolarcontrol),implementingprocess,portsandsafetyrequirementforoperator.系統描述:系統做到什么程度,如何關聯不同模塊、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、計數和其他多級控制)、實施流程、操作員的端口和安全標準。Physicalrequi

21、rement:includesufficientspace,location,peripheralenvironment,etc.物理要求:包括有足夠的空間,位置,周邊環境等。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,outputprogramanddetailedexpla

22、nation,reproductionofsoftwareprovisionandretentioncondition,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

23、的發展過程中進行,包括模塊測試和集成分離測試。Otherrequirementtosupplier:suchasfinishedsystemvalidation,qualitycontrolandchangecontrolondevelopingprocess,etc.對供應商的其他要求:如在發展進程中完成系統驗證、質量控制和變更控制等。Systemdesign系統設計Systemdesignshouldcomposeofsystemconfigurablechartdesign,hardwaredesign,andsoftwaredesign.Afterdocumentofsystemdes

24、ignreviewedandapprovedbyconsumerwhichshouldbepreparedbysupplier,systemconfigurablechartdesignshouldbecarriedout,includingsystemPID(processandinstrument),I/O(input/output)connectiondiagram,controlelementparetodiagram.系統設計應該由系統配置圖、硬件設計和軟件設計組成。在供應商準備的系統設計被用戶評估和檢驗后，可配置的系統圖紙設計應該完成,包括系統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:包括系統軟件、應用和數據。5.3.3IQIQshouldbecarriedouttoensurethatsysteminstallationisfitfordesigncriteriaandneededtechnicaldatashouldbecompletelyprov

27、ided.Specialcontentasfollow:IQ應該確保該系統安裝符合設計標準和工藝需求，數據完全提供。特殊內容如下: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.文件確認應該由用戶工藝要求、SOP,培訓計劃,售后服務協議、設備庫存，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/輸出設備清單和連接圖，備件清單和維護規程。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.系統安裝環境的檢驗和記錄: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.記錄關鍵設施以及條件,鑒定的公共設施應該跟說明一致:包括消防報警公告/預防系統、冷卻系統、電力及調整,持續供電、大面積網絡連接,本地區域網絡連接,災難恢復、電話圖形/模擬等(3) Qualifythatrecordsystemisfitforrequirementofman-machineengineer.條件和記錄系統符合人控機工程師的要求。5.3.3. Systemtestandqualification4 系統測試、條件(1) ThefirststeptodoistoqualifythatreportitemsofFAT

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

33、ayofcalibration.Calibrationshouldbefitfordefinitecriteriaandcorrespondingcertificationshouldbeprovided.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/O(input/output)signaltestshouldbecarriedoutsoastoensurethatsinglecantransmitfromcontrolsystemtodeviceandreturn.I/O(輸入/輸出)信號試驗應確保信號可以在控制系統設備間進行傳輸和反饋。 Dataa

34、cquisitionandtransmissionandsignalmemorytest數據采集,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和運行符合設計標準，內容

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

36、e.g.maximumcommunicationload,processofconsiderabledatadocument,etc.)testforallfunctionofsystemanddecisionroutinesshouldbecarriedoutinaccordancewithvariousrequirementsandcriteriasuppliedbysystemdefinition.(Itisimportantthatafunctionaldiagramincludingallbranchroutinesshouldbeprovided.)根據系統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、過程相當大的數據文件等)試驗檢查系統和決策程序的功能,應根據系統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的偏差是非常重要的。）Testforalarmandinterlock:efficacyofcorrespondingprogramshouldbetestedontheconditionofalarmandinterlockforsysteminaccordancewithsystemoperationmanual.檢測報警及連鎖:程序連鎖應根據報警條件及系統連鎖操作手冊進行測試。Testfortimerandsequencer

38、:establishtimeandprogramofsystemgeneratingcorrespondingfunctionaccordingtosystemoperationmanualsoastovalidateefficacyofsystemtimingororderingprogram.定時器和定序器測試:根據系統的操作手冊設置時間和系統產生相應的功能以確認系統有效時間或程序命令Testfordatadisposalandmemory測試數據處理和記憶(1) Qualifycorrectdatamemory,collectionandsearchofsystem'own.正確

39、的數據記憶,準確的數據采集和系統的自我搜索的確認。(2) Qualifydisposalofdataoutputlength,carryandempty數據處理的輸出長度、承載和空載的確認(3) Qualifythefunctionofsavingdatatocorrespondingfolder.數據保存到相應文件夾的功能確認。Testforshutdown/recovery關機/恢復測試5.3.4. (1)Checkconditionofthedataacquisitionbeforeandaftershutdownsoasto6 ensurethatdatahavenotbeendama

40、gedorlost.在系統關閉之前和之后檢查數據采集的情況,確保數據沒有損壞或丟失。(2) Checkthefunctionofbackuppowersupply,uninterruptiblepowersupply,poweradjusterandpowergenerator.檢查備用電源的供應、不間斷電源供應器、電力調節器和電力發電機。(3) Systembreakdownsorfailuresshouldbemadeinaccordancewithsystemoperationmanualsoastoensurethatback-upsystemshouldbeprovided.系統故障

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

42、.PQ的目的是確認系統運行過程中的有效性和穩定性方面的情況。測試項目應確定跟期望達到的結果相一致、二次確認也應該執行。Ifsystemispartofproduction,laboratoryorutilities,PQofsystemshouldbecompletedconformitywithPQofequipment(utilities).如果系統是生產,實驗室或公共設施系統的一部分,系統的PQ必須根據設備的PQ進行完整性測試。5.3.5. IfamanualsystemisbeingreplacedbycomputerizedandPLCcontrol1system,thetwosho

43、uldberuninparallel.當一個人工系統被電腦,PLC控制系統取代時,兩者需要平行運行。5.3.5. Regardingtoproductionequipment,thetestforproductspecification,suchas2assay,testforpackagingspecification,etc,shouldbecarriedoutsoastoensurethattheallprocesscontrolfunctionsareeffective.Testsshouldbecarriedoutforatleast3consecutivebatchesonthes

44、omeproductioncondition.對于生產設備,要進行產品規格測試,如化驗、包裝規格測試等等,確保所有的過程控制功能都是有效的，應當在相同的生產的條件下進行至少3個連續批次的測試。Monitoringforequipmentofconsecutiveprocessdisposalshouldbecarriedout,e.g.indexofclean-airsystem,suchasdustparticle,microorganism,temperature,humidity,airflow,pressuredifference,airexchangefrequency,etc,sh

45、ouldbemonitoredduringaperiod.對設備的連續過程進行監控應當進行,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,應在一個周期內被監控。Validationdeviation偏差驗證5.3.6 Thedisposalofsystemvalidationdeviationcanreferto<ValidationOrganizationandImplementation>.處置系統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，和數據庫的臨界參數變更組成。Ifchangeoccurring,changecontrolshouldbecarriedouts