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编号页码SOP No./SOP01809/01Page No./Page1of11Computerised SystemValidation计算机系统验证Dept.部门质量保证部QA/Effective Date生效日期年月、.Year/Month/_______Pate/日Confidential Level机密等级绝密口机密口秘密□Top-secret ConfidentialCrypticalDistribution List:分发清单部、部、固体制剂部、.物控部、工程部、技术部、设备部QA QCOSP LoEN TDEQDraft起草Review Review审核Review Review审Review Review审Approve批准责任人人审核人人审核人核人审核人核人人Role部门Dept.QA QCOSP Lo.EN TDEQ QD姓名Name签Signature名Date日期目的1ObjectiveAny unauthorizeduse andcopy isforbidden.未经授权,不得使用或拷贝and assessmentof influencedsystems should be carried out,where necessary,revalidation shouldalso be carried out for relevantsystems.对于变更对其他有关系统的影响,应当进行考核和系统评估,必要时,相关系统还要进行再验证6The recordsshould bemade orcompleted atthe timeeach actionis taken,such aschangeapplication,assessment,approval andrevalidation,and insuch away thatallchanges aretraceable.记录在每时每刻都要进行,如变更申请、评估、审批和再验证,用这样一种方式保证所有的变化可追踪附录AnnexNone无相关文件Related Documents6SOP01801Validation Organizationand Implementation验证的组织和实施7修订记录8Revision HistorySOPNo.Effective Date编号修改内容生效日期Change ContentsNewdocumentSOP01802/01/新文件Test andassessment should be takenfor URS,design,purchase,installation,function,aswell asprocess adaptabilityof computerized and PLC control systemrelated to GMP incompliancewith this SOP so as to ensure thatcomputerized and PLC arefit for designrequirement andstated technicalcriteria andare ableto workstably fora longtime.测试、评估采取的、设计、采购、安装、功能以及计算机控制和控制系统符合URS PLCGMP,以确保计算机和符合设计要求和工艺要求并且能够稳定工作很长时间PLC范围2ScopeThis SOPis fit for thevalidation managementof computerized and PLC control systemrelatedtoGMP,which applyto materialcontrol andmanagement,laboratory equipmentcontroland communicationmanagement,manufacturing processcontrol,and utilitiescontrol.本适用于电脑,控制系统的管理是否符合物料控制和管理,实验设备控制和SOP PLCGMP,通信管理、生产过程控制、公用设施的控制的验证职责3ResponsibilitiesQA is responsible fordrafting,revising,reviewing,training,implementing andsupervisingthis SOP.负责起草、修订、审核、培训、实施和监督本QA SOPThequality directorisresponsiblefor approvingthisSOP.质量副总负责批准本SOPo相关部门Relevant departmentsare responsiblefor reviewing and implementingthis SOPo负责审核和实施本SOPo定义4DefinitionsComputerized orPLC control system:It composed of hardware,system software,applications,and relevantperipheral devicesis asystem thatcan implementa functionanda setof functions.无论是计算机化还是控制系统:都是由硬件、系统软件、应用、及相关的周边设备组成的PLC一个系统,可以实现某一功能和一套功能Source code:It issource programof computerwhose formatprogram languagecan bereadby operator,before computerexecution,it should be translateto machinelanguagewhose formatcan beexecuted bycomputer.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程序5Procedures61Organization ofValidation teamand responsibility.验证机构及责任
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1.1Validation teamis composedof supplier,QA,Equipment Department,usedepartment.验证团队由供应商,、工程设备部和使用部门组成
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1.2QA系统验证实施部门的职责Implementation departmentresponsibility of system validation•Use department:Responsible forproviding writtenURS,preparing validation protocoland report,implementing approvedIQ andOQ protocol,completing final report andparticipating validation deviation investigation and alteration review.・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IQQQ协议,完成最终报告偏差并参与调查及变更验证审核•Equipment Department:Responsible forcooperating withuse departmentto prepareURSand validationprotocol,receiving system,installing system and implementingIQ,guiding use department onIQ andOQ processand participatingvalidation deviationinvestigationand alterationreview.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,实施指导使•IQ,用部门关于和的验证过程和参与验证偏差调查和变更回顾IQ OQ•QA:Responsible forreviewing validationdraft andfinalreport,implementing validationprotocol,participatingvalidation deviationinvestigationandalterationapproval andarchivingvalidationprotocoland report.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QA:批准验证方案和归档,并做好报告52System classification系统分级
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2.1Before validation,evaluation andclassification should be carried out for system so as toinsurethat differentgrade validation should be provided fordifferent typecomputerized andPLCcontrol system.Classification as follows: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控制系统,分类如下,PLCValidationClassification描述验证方Description method分类法Operating system,Established networkand operatingsystem forValidatenamenetwork网络操作commerce.E.g.DOS\Windows95/98NT.and edition系统,已做好网络和操作系统例如:DOS Windows95/98NT.确认名number称及版本号These systemis designedby non-consumer fordrivingfirmware whichcan beinstalled inspecialStandard device,integrate circuitIC forapplication,read onlyValidatemicrocontroller,memory ROM,random accessmemory RAM,constructionsensitive PLCsometimes,such asbar codemodem,andequipment标准配single-cycle controller,filling device,Checkweigher,确configuration置,微控制器,灵temperature controlleretc.这些系统是根据用户可以认构造及配置敏的电气设备安装在特殊的集成电路IC的驱动固件,只读存储器、随机存取存储器、例如条形码调ROM RAMPLC,制解调器控制器、灌装设备,重量控制、,single-cycle温度控制器等来设计的Validate用Ready-made packagefor commerce,such asmuStandard packageapplicationplan software,standard chemicalanalysis software标准程序包process验证应etc.用过程现成的软件包,例如多计划软件,标准化学分析软件等Configurable Usersdevelop theirown applicationthrough Auditsupplierpackage pre-definite softwaremodules anddeveloping andvalidate可配置的程序包applicationprocess andapplicationmodules canbe carried out inthis system,some pre-such asman-machine dialogueport,management establishedcontrol,data acquisitionsystem,adaptive controlcodesystem for laboratory,information managementsystem forlaboratory,material requirementplanningsystem,data processingsystemforsystem/application andproduct,part PLCetc.用户自己开发应用可通过软件模块和发展pre-definite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等PLCImplement allvalidationSystemdeveloped processesofModifying ordeveloping system in compliancewithwithin firm公司内computerized修改或开发符合自己要求的系统requirement ofhimself部系统开发and PLCcontrol实施计system算机及控制系统验PLC证的全过程
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2.2Some computerizedand PLCcontrol systemwith complexconstruction should be classifiedin accordance withdeveloping degreeof eachmodule.一些计算机化的和控制系统复杂程度应当跟各分类模块的开发程度相一致PLC
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2.3Validation of computerizedandPLCcontrolsystem should be carried out not only foruseprocess of system,e.g.validation of new system should be carried outnotonlyfor initialdefinitionand designingphase butalso wholelife cycleof systemdevelopment.计算机验证,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PLC阶段进行,而且贯穿于全部生命周期体系的发展53Validation implementation,验证实施
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3.1URSURS should be prepared by systemuser andproject expertdetailed withfundamentalrequirement,expectation andperformance index ofnew/changed computerizedand PLCcontrolsystem,which willbe useto determinesystem designingcriteria.Content asfollow:应该为系统用户和项目专家准备基本要求详细的,预期和新的性能指标、更改计算机化和URS控制系统,可以用来决定系统设计标准内容如下PLC
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1.1System description:what todo aboutsystem,how connectionand interactionbetweendifferent module,control methodse.g.logic control,separation control,interlock control,alarm control,location control,temperature control,pressure control,time control,countingand othermultipolar control,implementing process,ports andsafety requirementforoperator.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,压力控制、时间控制、计数和其他多级控制、实施流程、操作员的端口和安全标准
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1.2312Physical requirement:include sufficientspace,location,peripheral environment,etc.物理要求:包括有足够的空间,位置,周边环境等
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1.3Document criteriafor hardware:include chartpaper,schematic chart,hand book,spareparts listetc.硬件的文件标准:包括:图纸,原理图,操作指南,备件清单等
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1.4Document criteriafor software:include programnumber andrevising number,outputprogram anddetailed explanation,reproduction ofsoftware provisionand retentioncondition,system blockdrawing andconfiguration list.软件的文件标准:包括程序编号和修改编号,输出接口程序和详细说明、软件的追加和保留条件、系统分程序图纸和配置清单
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1.5Test requirement:test itemsand recordrequired tobe carried out onsystem developingprocess,including moduleseparated testand integratedtest.测试要求:测试项目和记录必须在系统的发展过程中进行,包括模块测试和集成分离测试
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1.6Other requirementto supplier:such asfinished systemvalidation,quality controlandchange controlon developingprocess,etc.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
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3.2System design系统设计
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2.1System designshould composeof system configurable chart design,hardware design,andsoftware design.After documentof systemdesign reviewedand approved by consumerwhichshould beprepared bysupplier,systemconfigurablechartdesignshould be carriedout,including systemRID processand instrument,I/O input/output connection diagram,control elementpareto diagram.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,包括系统输入/输出连接图、连接原PID,I/O理帕累托图
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2.2Hardware design:include allI/O input/output connectiontemplate andtype,CPUselection,communication template,man-machine Interfacecontroller,screen viewerselection,medium relay,memory,printer,auxiliary powerunit,electronicelement/wire/cable,other elementsetc.硬件设计:包括所有输入/输出连接模板和类型,选型,通信模板、人机界面控制器,I/O CPU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5323Software:include systemsoftware,application,and data..一软件:包括系统软件、应用和数据・・
5.33QIQ should be carried out to ensure thatsystem installation is fit for design criteria and应该确needed technicaldata should be completelyprovided.Special contentasfollow:IQ保该系统安装符合设计标准和工艺需求,数据完全提供特殊内容如下
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3.1Document qualification should consistof consumertechnical guide,SOP,training plan,post-sale serviceagreement,equipment inventory,security program,hardwarequalification,software qualification,source code,instrument list,instrument calibrationprocedure,PID,control loopdiagram,I/O input/output devicelist andconnectiondiagram,spare partslist,and maintenanceprocedure.文件确认应该由用户工艺要求、培训计划,售后服务协议、设备库存,安全程序、硬件说SOP,明,软件说明,源代码、仪器清单、仪器校准程序、、控制回路图输入/输出设备清单PID,1/0和连接图,备件清单和维护规程Installation processqualification:qualify thatinstallationis fitfor requirement PIDand operatingmanual.安装过程说明:安装符合和操作手册的要求PIDCircumstance andutilities qualification事件和实用程序说明1Qualify andrecord circumstanceof systeminstallation,such asclean level,
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3.3radiofrequency/electromagnetic interference,physical protection,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2Record conditionof criticalutilities andqualify thatcritical natureof utilitiesshould be fitfor instructionincluding firealarm announcement/prevention,cooling system,electricpower andits adjustment,continuous powersupply,wide areanetwork connection,local areanetwork connection,disaster recovery,telephone figure/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,本地区域网络连接,灾难恢复、电话图形/模拟等3Qualify thatrecord systemisfitforrequirementof man-machine engineer.条件和记录系统符合人控机工程师的要求System testand qualification系统测试、条件1The firststep todo isto qualifythat reportitems ofFAT factoryacceptance test shouldbe completelysupplied bysupplier andfitfordesigncriteria.第一步要做的是,报告项目的验收测试应该完全由供应商提供,适用于设计标准FAT2Necessary testshould be carriedout forsystemon operationalcircumstance.Essentialcontent asfollow:应该对系统运行情况开展必要的测试基本内容如下•All instrumentsand metersshould becalibrated andon expireday ofcalibration.Calibration should be fitfor definitecriteria andcorresponding certificationshould beprovided.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 signaltestshould be carriedout so as to ensure thatsinglecan transmitfrom controlsystem todevice andreturn.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I/O数据采集,传送和信号记忆测•Data acquisitionand transmissionand signalmemory test试•Other tests其他测试OQ operationqualification运行确认The purposeof OQis thatall functiontests should becarriedout onoperationalcircumstance so as to ensure thatsystem andoperation should befitfordesigncriteria.Content asfollow;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OQTest forsystem security:worst case”of alllogic systemsshould betested,e.g.useauthority ofdifferent personsshouldbetested soas toidentify thatoperation unauthorizedshouldbe forbidden.测试系统安全“最坏情况”的系统逻辑应该进行测试,如使用不同权限以便确认未经授权运行是否被禁止Various processescontrol functiontests requiredby systemrequest:u worstcase”e.g.maximum communicationload,process ofconsiderable datadocument,etc.test forallfunction ofsystemanddecision routinesshouldbecarriedoutinaccordance with variousrequirementsand criteriasupplied bysystem definition.It isimportant thata functionaldiagramincluding allbranch routinesshouldbeprovided.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Test foralarm andinterlock:efficacy ofcorresponding programshouldbetested onthecondition ofalarm andinterlock forsysteminaccordance withsystem operationmanual.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Test fortimer andsequencer:establish timeand programofsystemgeneratingcorresponding functionaccording tosystem operationmanual soas tovalidate efficacyofsystem timingor orderingprogram.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
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1.5Test fordata disposaland memory测试数据处理和记忆1Qualify correctdata memory,collection andsearch ofsystems own.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数据处理的输出长度、承载和空2Qualify disposalof dataoutput length,carry andempty载的确认3Qualify thefunction ofsaving datato correspondingfolder.数据保存到相应文件夹的功能确认Test forshutdown/recovery关机/恢复测试⑴
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1.6Check conditionof thedata acquisitionbefore andafter shutdownsoastoensurethatdata havenot beendamaged orlost.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2Check thefunction ofbackup powersupply,uninterruptible powersupply,poweradjuster andpower generator.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3System breakdownsor failuresshouldbemade inaccordance withsystem operationmanualsoastoensurethat back-up system shouldbeprovided.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Other functiontest其他功能测试
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1.7Performance qualificationPQ性能确认
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3.5The purposeof PQis thatqualify theefficacy andstability ofrunning processonoperational circumstance.Test itemsshouldbeestablished inaccordancewithachievingdesired resultand duplicatequalificationshouldbe alsocarriedout.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PQ的结果相一致、二次确认也应该执行If systemis partof production,laboratory orutilities,PQ ofsystemshouldbe completedconformitywith PQof equipmentutilities.如果系统是生产,实验室或公共设施系统的一部分,系统的必须根据设备的进行完PQ PQ整性测试
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5.1If amanual systemis beingreplaced bycomputerizedandPLCcontrolsystem,the twoshouldbe runin parallel.当一个人工系统被电脑,控制系统取代时,两者需要平行运行PLC
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5.2Regarding toproduction equipment,the testfor productspecification,such asassay,testfor packagingspecification,etc,shouldbecarriedoutsoastoensurethat theall processcontrolfunctions areeffective.Tests shouldbecarriedoutforat least3consecutivebatches onthe someproduction condition.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,确保所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个连续批次的测试
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5.3Monitoring forequipment ofconsecutive processdisposal shouldbecarriedout,e.g.indexofclean-air system,such asdust particle,microorganism,temperature,humidity,air flow,pressure difference,air exchangefrequency,etc,shouldbemonitored duringaperiod.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,例如尘埃粒子、微生物、温度、湿度、风量、压差、换气频率等,应在一个周期内被监控5354Validation deviation・…偏差验证
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3.6The disposalofsystemvalidationdeviationcan refertoValidation Organizationandlmplementation.处置系统偏差验证可参阅〈验证组织和实施变更控制Change control
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3.7Change classification:change iscomposedofhardware change,software changeandchange ofcritical parametersin database.变更的分类:变更是由硬件变更、软件变更,和数据库的临界参数变更组成什
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7.1change occurring,change controlshouldbecarriedoutsoastoensurethat systemshouldbe onvalidated status.若发生改变,变更控制应确保系统处在已验证状态
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37.21Written applicationshouldbepreparedbyusedepartment,including changereason,evidence,and contentand implementationprotocol.使用部门应该准备好书面申请,包括变更原因,证据,内容和实施方案2Professional technologist,the headof relevantdepartment andQA areresponsible forassessing,reviewingandapproving.工艺主管,相关部门经理和负责评估、审查和批准QA3Whether revalidationshouldbe taken ornot shouldbe onthe basisof impactingrange.E.g.validationshouldbecarriedoutforthe partsof changewhich impactingthe validatedstatuesofcomputerizedandPLCcontrolsystem;sometimes revalidationshould notbecarried outafter assessmentif sufficientevidence canbeprovided.是否再验证应该在影响范围的基础上,如当改变的部分影响计算机控制系统的验证状态FLC时,改变的各个部分应当进行验证;有时如果在评估之后可以提供充分的证据表明没有影响,那么就不需要再验证,4The implementationshouldbecarriedoutafter changeapprovedbyrelevantpersonnel andaltering contentof approvedchange shouldbe forbidden.变更实施后,经有关人员、改变批准的变更内容是被禁止的不会翻译5Influence ofchange toother relevantsystemshouldbetakeninto consideration,。