计算机系统验证方案

55Month/月ionEQMonth/月ionEQ设机密质量保证部口CrypticalComputerisedSystemValidat计算机系统验证Dept.部门：EffectiveDate生效日期：Year/ConfidentialLevel机密等级：□Confidential

QA□Top-secret□Confidential

QA密DistributionList?:分发清单：QA部、QC部、OSF固体制剂部、Lo.物控部、EN工程部日呷6技术部、备部 日1Objective目的Role责任人Draft起草人Review审核人Review审核人Review审核人Review审核人Review审核人Review审核人Approve批准人Dept.部门QAQCOSPLo.ENTDEQQDName姓名Signature签名Date日期TestandassessmentshouldbetakenforURS,design,purchase,installation,function,aswellasprocessadaptabilityofcomputerizedandPLCcontrolsystemrelatedtoGMPincomplianeewiththisSOPsoastoensurethatcomputerizedandPLCarefitfordesignrequirementandstatedtechnicalcriteriaandareabletoworkstablyforalongtime.测试、评估采取的URS设计、采购、安装、功能以及计算机控制和 PLC控制系统符合GMP以确保计算机和PLC符合设计要求和工艺要求并且能够稳定工作很长时间。Scope范围ThisSOPisfitforthevalidationmanagementofcomputerizedandPLCcontrolsystemrelatedtoGMP,whichapplytomaterialcontrolandmanagement,laboratoryequipmentcontrolandcommunicationmanagement,manufacturingprocesscontrol,andutilitiescontrol.本SOP适用于电脑，PLC控制系统的管理是否符合GMP物料控制和管理，实验设备控制和通信管理、生产过程控制、公用设施的控制的验证。Responsibilities职责QAisresponsiblefordrafting,revising,reviewing,training,implementingandsupervisingthisSOP.QA负责起草、修订、审核、培训、实施和监督本 SOPThequalitydirectorisresponsibleforapprovingthisSOP.质量副总负责批准本SOP。RelevantdepartmentsareresponsibleforreviewingandimplementingthisSOP。相关部门负责审核和实施本SOP。Definitions定义ComputerizedorPLCcontrolsystem:Itcomposedofhardware,systemsoftware,applications,andrelevantperipheraldevicesisasystemthatcanimplementafunctionandasetoffunctions.无论是计算机化还是PLC控制系统：都是由硬件、系统软件、应用、及相关的周边设备组成的一个系统,可以实现某一功能和一套功能。Sourcecode：Itissourceprogramofcomputerwhoseformat(programlanguage)canbereadbyoperator,beforecomputerexecution,itshouldbetranslatetomachinelanguagewhoseformatcanbeexecutedbycomputer.源代码：它是计算机的源程序(程序语言),可以在电脑执行前被计算机识别,它应该被翻译成可以被计算机识别的机器语言。Procedures程序

ofValidationteamandresponsibility验证机构及责任Validationteamiscomposedofsupplier,QA,EquipmentDepartment,usedepartment.验证团队由供应商，QA、工程设备部和使用部门组成。ImpIementationdepartmentresponsibilityofsystemvalidation系统验证实施部门的职责Usedepartment:preparing validation protocolapprovedIQandOQprotocol,participating validationalterationreview.Responsible for providingandreport,

completing finaldeviationwrittenURS,implementingreportinvestigationand

and使用部门ofValidationteamandresponsibility验证机构及责任Validationteamiscomposedofsupplier,QA,EquipmentDepartment,usedepartment.验证团队由供应商，QA、工程设备部和使用部门组成。ImpIementationdepartmentresponsibilityofsystemvalidation系统验证实施部门的职责Usedepartment:preparing validation protocolapprovedIQandOQprotocol,participating validationalterationreview.Responsible for providingandreport,

completing finaldeviationwrittenURS,implementingreportinvestigationand

and使用部门：负责提供书面的URS准备验证方案和报告、实施批准协议,完成最终报告偏差并参与调查及变更验证审核。EquipmentDepartment: Responsiblefor cooperating withusedepartmenttoprepareURSandvalidationprotocol,receivingsystem,installing systemandimpiementing IQ,guiding usedepartmentonIQandOQprocessandparticipatingvalidationdeviationinvestigationandalterationreview.设备部门：负责准备使用部门的合作协议，并确认你接收系统，安装系统,实施IQ,指导使用部门关于IQ和OQ的验证过程和参与验证偏差调查和变更回顾。QA:Responsible forreport, impiementingvalidation deviationreviewingvalidationvalidation protocol,investigation andalterationIQ,OQdraftandfinalparticipatingapprovalandarchivingvalidationprotocolandreport.QA:负责审查验证，也是最后一项报告草案、实施验证方案及变更验证偏差的批准验证方案和归档，并做好报告。Systemclassification系统分级validation,evaluationandclassificationshouldbecarriedoutforsystemsoastoinsure thatshouldbeprovided for differentcontrolsystem.Classificationasfollows:在验证之前，评估和分级应当进行系统分类,参与调查validationdifferent gradetypecomputerized andPLC,以确保不同等级验证需提供不Description描述Validationmethod验证方法Description描述Validationmethod验证方法Operating

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developedforapplication,(ROM),randomPLCsometimes,suchasmodem, single-cyclefilling device,temperaturecontroller这些系统是根据用户可以安装在特殊的集成电路(IC)的驱动固件，只读存储器(ROM)随机存取存储器(RAM)、PLC,例如条形码调制解调器,single-cycle控制器、灌装设备，重量控制、温度控制器等来设计的。Ready-madepackageforcommerce,suchasmultiplansoftware, standardchemicalanalysissoftwareetc.现成的软件包，例如多计划软件，标准化学分析软件等。Usersdeveloptheirownapplicationthroughpre-definitesoftwaremodulesanddevelopingapplicationmodulescanbecarriedoutinthissystem,suchasman-machinedialogueport,managementcontrol,dataacquisitionsystem,adaptivecontrolsystemforlaboratory,informationmanagementsystemforlaboratory,materialrequirementplanningsystem,dataprocessingsystemforsystem/applicationandproduct,partPLCetc.用户自己开发应用可通过pre-definite件模块和发展应用模块都可以在这个系统中运行,采用人机对话端口，管理控制，数据采集系统，自适应控制系统，信息管理系统，原材料需求计划系统、数据处理系统和产品、系统应用部分可编程序控制器(PLC)等。 ModifyingordevelopingsystemincomplianeewithrequirementofValidate

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开发himself修改或开发符合自己要求的系统processesofcomputerizedandPLCcontrolsystem实施计算机及PLC控制系统验证的全过程computerized andPLCcontrol systemwithcomplexconstructionshouldbeclassifiedinaccordaneewithdevelopingdegreeofeachmodule.一些计算机化的和PLC控制系统复杂程度应当跟各分类模块的开发程度相一致。ofcomputerizedandPLCcontrol systemshouldbecarriedoutnotonlyforuseprocessofsystem,.validationofnewsystemshouldbecarriedoutnotonlyforinitialdefinitionanddesigningphasebutalsowholelifecycleofsystemdevelopment.计算机验证,PLC控制系统不仅体现在系统使用过程，如新系统的验证不仅在初始定义和设计阶段进行，而且贯穿于全部生命周期体系的发展。Validationimplementation验证实施531 URSexpertexpectation andandPLCcontrolsystem designingexpertexpectation andandPLCcontrolsystem designingperformaneeindexofnew/changedcomputerizedsystem,whichwillbeuseto determinecriteria.Contentasfollow:,预期和新的性能指URS,预期和新的性能指标、更改计算机化和 PLC控制系统，可以用来决定系统设计标准。内容如下：process,portsandsafetyrequirementforoperator.Systemdescription:whattodoaboutsystem,howconnectionandinteractioncontrol,locationcontrol,betweendifferentseparation control,control, temperaturecounting andothermodule,interlockcontrol,multipolarSystemdescription:whattodoaboutsystem,howconnectionandinteractioncontrol,locationcontrol,betweendifferentseparation control,control, temperaturecounting andothermodule,interlockcontrol,multipolarcontrolcontrol,pressurecontrol),methods.logicalarmcontrol,control, timeimplementing系统描述：系统做到什么程度，如何关联不同模块、控制方法(例如:逻辑控

制、分离控制,连锁控制、报警控制、位置控制,温度控制,制、分离控制,连锁控制、报警控制、位置控制,温度控制,压力控制、时间控制、计数和其他多级控制Physicalrequirement:peripheralenvironment,etc.物理要求:包括有足够的空间)、实施流程、操作员的端口和安全标准。includesufficientspace,location,,位置,周边环境等。Documentcriteriaforhardware:includechartpaper,schematicchart,handbook,sparepartslistetc.硬件的文件标准:包括:图纸,原理图,操作指南,备件清单等。Documentcriteriaforsoftware:revisingnumber,outputprogramreproductionofsoftwareprovisionincludeprogramanddetailedandretentionnumberandexplanation,condition,systemblockdrawingandconfigurationlist.软件的文件标准:包括程序编号和修改编号件的追加和保留条件、系统分程序图纸和配置清单。Testrequirement:testitemsandrecordrequiredoutonsystemdevelopingprocess,includingtestandintegratedtest.测试要求:测试项目和记录必须在系统的发展过程中进行集成分离测试。Otherrequirementtosupplier:suchasvalidation,qualitycontrolandchangecontrolprocess,etc.,输出接口程序和详细说明、软tobecarriedmoduleseparated,包括模块测试和finishedsystemondeveloping对供应商的其他要求:如在发展进程中完成系统验证、质量控制和变更控制等。.2.1Systemdesign系统设计Systemdesignshouldcomposeofsystemconfigurablechartdesign,hardwaredesign,andsoftwaredesign.Afterdocumentofsystemdesignreviewedandapprovedbyconsumerwhichshouldbepreparedbysupplier,systemconfigurablechartdesignshouldbecarriedout,includingsystemPID(processandinstrument),I/O(input/output)connectiondiagram,controlelementparetodiagram.系统设计应该由系统配置图、硬件设计和软件设计组成。在供应商准备的系统设计被用户评估和检验后，可配置的系统图纸设计应该完成,包括系统PID,I/O(输入/输出)....3machineInterfacecontroller，screenviewerselection，mediumrelay，memory，printer，auxiliarypowerunit，electronicelement/wire/cable，otherelementsetc.硬件设计：包括所有I/O（输入/输出）连接模板和类型，CPU选型,通信模板、人机界面控制器，屏幕查看选择、中继电器、记忆存储器、打印机、辅助动力装置，电子部件/电线/电缆、其他元件等。Software:includesystemsoftware，application，anddata.软件:包括系统软件、应用和数据。IQisshouldbeIQshouldbecarriedouttoensurethatsysteminstallationfitfordesigncriteriaandneededtechnicaldatacompletelyprovided.Specialcontentasfollow:IQ应该确保该系统安装符合设计标准和工艺需求，数据完全提供。容如下:Documentqualificationguide,SOP,trainingequipmentinventory,softwarequalification,sourcecode,instrumentlist,instrumentcalibrationprocedure,PID,controlloopdiagram,I/O(input/output)devicelistandconnectiondiagram,sparepartslist,andmaintenanceprocedure.文件确认应该由用户工艺要求、SOP培训计划，售后服务协议、设备库存，安全程序、硬件说明,软件说明,源代码、仪器清单、仪器校准程序、PID、控制回路图，1/0(输入/输出设备清单和连接图，备件清单和维护规程。Installationprocessqualification:qualifythatinstallationisfitforrequirementPIDandoperatingmanual.安装过程说明：安装符合PID和操作手册的要求。Circumstanceandutilitiesqualification事件和实用程序说明(1)Qualifyandrecordcircumstanceofsysteminstallation，suchascleanlevel，radiofrequency/electromagneticinterference，physicalprotection，temperature，humility，sound，lighting，etc.系统安装环境的检验和记录:例如洁净水平、射频/电磁干扰、物理保护、温度、湿度、声音、照明等。shouldplan,security特殊内technical

agreement,consistofconsumerpost-saleserviceprogram，hardwarequalification，Recordcondition ofcriticalutilitiesandqualifythatcriticalnatureofutilitiesshouldbefitforinstructionincludingfirealarmannouncement/prevention,coolingsystem,electric powerandits adjustment, continuous powersupply,wideareanetworkconnection, localareanetworkconnection,disasterrecovery,telephonefigure/analog,etc.记录关键设施以及条件，鉴定的公共设施应该跟说明一致：包括消防报警公告/预防系统、冷却系统、电力及调整，持续供电、大面积网络连接地区域网络连接，灾难恢复、电话图形/模拟等man-Qualifythatrecordsystemisfitforrequirementofmachineengineer.man-条件和记录系统符合人控机工程师的要求。5.3.3Systemtestandqualification.4■ 系统测试、条件ThefirststeptodoistoqualifythatreportitemsofFATby(factory acceptancetest)shouldbecompietely suppliedbysupplierandfitfordesigncriteria.第一步要做的是，报告项目FAT的验收测试应该完全由供应商提供，适用于设计标准。Necessarytestshouldbecarriedoutforsystemonoperationalcircumstanee.Essentialcontentasfollow:应该对系统运行情况开展必要的测试。基本内容如下：instruments andmetersshouldbecalibratedandonexpiredayofcalibration. Calibration shouldbefitfordefinitecriteriaandcorrespondingcertificationshouldbeprovided.所有仪器仪表应该被校准和标注过期日，校准应该有明确的标准及应提供相应的检查证件。I/O(input/output)signaltestshouldbecarriedoutsoastoensurethatsinglecantransmitfromcontrolsystemtodeviceandreturn.I/O(输入/输出)信号试验应确保信号可以在控制系统设备间进行传输和反馈。Dataacquisitionandtransmissionandsignalmemorytest数据采集,传送和信号记忆测试Othertests?其他测试OQ(operationqualification)运行确认

ThepurposeofOQisthatallfunction testsshouldbecarriedoutonoperationalcircumstancesoastoensurethatsystemandoperationshouldbefitfordesigncriteria.Contentasfollow;oc的目的是进行所有功能运行情况方面的测试以确保系统和运行符合设计标准，内容如下：Testforsystemsecurity:“worstcase”ofalllogicsystemsshouldbetested,.cessescontrol“worstcaseofconsiderableofsystemanddecisionVariousrequest:processfunction测试系统安全:“最坏情况”的系统逻辑应该进行测试processescontrol“worstcaseofconsiderableofsystemanddecisionVariousrequest:processfunctionfunctiontestsrequiredbysystem“(.maximumcommunicationload,datadocument,etc.)testforallroutinesshouldbecarriedoutinaccordancewithvariousrequirementsandcriteriasuppliedbysystemdefinition.(Itisimportantthatafunctionaldiagramincludingallbranchroutinesshouldbeprovided.)根据系统要求进行的各种各样的过程控制功能的测试:“最坏情况”(例如最大通信承载、过程相当大的数据文件等)试验检查系统和决策程序的功能,应根据系统不同的要求和标准提供的定义。(提供功能图表包括所有出现的偏差是非常重要的。)Testforalarmandinterlock:efficacyofcorrespondingprogramshouldbetestedontheconditionofalarmandinterlockforsysteminaccordancewithsystemoperationmanual.检测报警及连锁:程序连锁应根据报警条件及系统连锁操作手册进行测试。Testfortimerandsequencer:establishtimeandprogramofsystemgeneratingcorrespondingfunctionaccordingtosystemoperationmanualsoastovalidateefficacyofsystemtimingororderingprogram.定时器和定序器测试:根据系统的操作手册设置时间和系统产生相应的功能以确认系统有效时间或程序命令535535535535534.65.7Testfordatadisposalandmemory测试数据处理和记忆(1)Qualifycorrectdatamemory,collectionandsearchofsystem'sown.正确的数据记忆，准确的数据采集和系统的自我搜索的确认。(2) Qualifydisposalofdataoutputlength,carryandempty数据处理的输出长度、承载和空载的确认Qualifythefunction ofsaving datato correspondingfolder.数据保存到相应文件夹的功能确认。Testforshutdown/recovery关机/恢复测试Checkcondition ofthedataacquisitionbeforeandaftershutdownsoastoensurethatdatahavenotbeendamagedorlost.在系统关闭之前和之后检查数据采集的情况，确保数据没有损坏或丢失。Checkthefunctionofbackuppowersupply, uninterruptiblepowersupply,poweradjusterandpowergenerator.检查备用电源的供应、不间断电源供应器、电力调节器和电力发电机。Systembreakdownsorfailuresshouldbemadeinaccordaneewithsystemoperationmanualsoastoensurethatback-upsystemshouldbeprovided.系统故障和失败的时候，能够根据系统的操作手册提供系统备份。Otherfunctiontest其他功能测试Performaneequalification(PQ)性能确认ThepurposeofPQisthatqualifytheefficacyandstabilityofrunningprocessonoperationalcircumstanee.Testitemsshouldbeestablishedinaccordaneewithachievingdesiredresultandduplicatequalificationshouldbealsocarriedout.PQ的目的是确认系统运行过程中的有效性和稳定性方面的情况。测试项目应确定跟期望达到的结果相一致、二次确认也应该执行。Ifsystemispartofproduction,laboratoryorutilities,PQofsystemshouldbecompletedconformitywithPQofequipment(utilities).如果系统是生产，实验室或公共设施系统的一部分，系统的PQ必须根据设备的PQ进行完整性测试。Ifamanualsystemisbeingreplacedbycomputerizedcontrolsystem,thetwoshouldberuninparallel.当一个人工系统被电脑，PLC控制系统取代时，两者需要平行运行。Regardingtoproductionequipment,thetestforspecification,suchasassay,testforpackagingspecification,etc,shouldbecarriedoutsoastoensurethattheallprocesscontrolfunctionsareeffective.Testsshouldbecarriedoutforatleast3consecutivebatchesonthesomeproductioncondition.对于生产设备,要进行产品规格测试,如化验、包装规格测试等等有的过程控制功能都是有效的，应当在相同的生产的条件下进行至少连续批次的测试。andPLCproduct,确保所3个Monitoringforequipmentofconsecutiveprocessdisposalshouldbecarriedout,.indexparticle,microorganism,pressuredifference,airmonitoredduringaperiod.ofclean-airsystem,suchtemperature,humidity,exchangefrequency,etc,asairshouldbedustflow,对设备的连续过程进行监控应当进行,如空气净化体系的指标子、微生物、温度、湿度、风量、压差、换气频率等监控。,例如尘埃粒,应在一个周期内被Validationdeviation偏差验证disposalofsystemvalidationdeviationValidationOrganizationandImplementation>.处置系统偏差验证可参阅<验证组织和实施>。canreferto<6767Changecontrol变更控制classification:changeiscomposedofhard