计算机系统验证方案

SOPNo./编号:SOP01809/01PageNo./页码:Page1of12Anyunauthorizeduseandcopyisforbidden.未经授权，不得使用或拷贝。ComputerisedSystemValidation计算机系统验证Dept.部门：EffectiveDate生效日期：ConfidentialLevel机密等级：□Top-secret绝密□Confidential机密□Cryptical秘密DistributionList:分发清单：QA部、QC部、OSP固体制剂部、Lo.物控部、EN工程部、TD技术部、EQ设备部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Year/年Month/月QA质量保证部Date/日ComputerisedSystemValidation计算机系统验证Approve/批准人：SOPNo./编号：SOP01809/01Date/日期：PageNo./页码：Page2of12TestandassessmentshouldbetakenforURS,design,purchase,installation,function,aswellasprocessadaptabilityofcomputerizedandPLCcontrolsystemrelatedtoGMPincompliancewiththisSOPsoastoensurethatcomputerizedandPLCarefitfordesignrequirementandstatedtechnicalcriteriaandareabletoworkstablyforalongtime.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。2Scope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。3Responsibilities职责QAisresponsiblefordrafting,revising,reviewing,training,implementingandsupervisingthisSOP.QA负责起草、修订、审核、培训、实施和监督本SOP。ThequalitydirectorisresponsibleforapprovingthisSOP.质量副总负责批准本SOP。RelevantdepartmentsareresponsibleforreviewingandimplementingthisSOP。相关部门负责审核和实施本SOP。4Definitions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。5Procedures程序5.15.1.15.1.2OrganizationofValidationteamandresponsibility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。Implementationdepartmentresponsibilityofsystemvalidation系统验证实施部门的职责Usedepartment:ResponsibleforprovidingwrittenURS,preparingvalidationprotocolandreport,implementingapprovedIQandOQprotocol,completingfinalreportandparticipatingvalidationdeviationinvestigationandalterationreview.ComputerisedSystemValidation计算机系统验证Approve/批准人：SOPNo./编号：SOP01809/01Date/日期：PageNo./页码：Page3of12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IQ,OQ协议,完成最终报告偏差并参与调查及变更验证审核。EquipmentDepartment:ResponsibleforcooperatingwithusedepartmenttoprepareURSandvalidationprotocol,receivingsystem,installingsystemandimplementingIQ,guidingusedepartmentonIQandOQprocessandparticipatingvalidationdeviationinvestigationandalterationreview.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:Responsibleforreviewingvalidationdraftandfinalreport,implementingvalidationprotocol,participatingvalidationdeviationinvestigationandalterationapprovalandarchivingvalidationprotocolandreport.QA:负责审查验证,也是最后一项报告草案、实施验证方案,参与调查及变更验证偏差的批准验证方案和归档,并做好报告。5.2Systemclassification系统分级5.2.1Beforevalidation,evaluationandclassificationshouldbecarriedoutforsystemsoastoinsurethatdifferentgradevalidationshouldbeprovidedfordifferenttypecomputerizedandPLCcontrolsystem.Classificationasfollows:在验证之前,评估和分级应当进行系统分类,以确保不同等级验证需提供不同类型的计算机化的,PLC控制系统,分类如下:Classification分类Description描述Validationmethod验证方法Operatingsystem,network网络操作系统,Establishednetworkandoperatingsystemforcommerce.E.g.DOS\Windows95/98NT.已做好网络和操作系统例如:DOS\Windows95/98NT.Validatenameandeditionnumber确认名称及版本号Standarddevice,microcontroller,sensitiveequipment标准配置,微控制器,灵敏的电气设备Thesesystemisdesignedbynon-consumerfordrivingfirmwarewhichcanbeinstalledinspecialintegratecircuit(IC)forapplication,readonlymemory(ROM),randomaccessmemory(RAM),PLCsometimes,suchasbarcodemodem,single-cyclecontroller,fillingdevice,Checkweigher,temperaturecontrolleretc.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。Validateconstructionandconfiguration确认构造及配置Standardpackage标准程序包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。Validateapplicationprocess验证应用过程ComputerisedSystemValidation计算机系统验证Approve/批准人：SOPNo./编号：SOP01809/01Date/日期：PageNo./页码：Page4of12Configurablepackage可配置的程序包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软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。Auditsupplierandvalidateapplicationprocessandsomepre-establishedcodeSystemdevelopedwithinfi