翻译后的计算机化系统验证模板

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Author'sSignature:授权者签名Yoursignatureindicatesthatthisdocumenthasbeenpreparedinaccordancewithexistingprojectstandardsandadequatelyreflectsthetasksanddeliverablesnecessaryforvalidationofthe<equipmentname>您的签名表明这份文件的准备符合现行项目标准并且充分反映人物u和可交付使用对<设备名称>验证的必要。AuthoredBy:经授权：Typed/PrintedName,Title姓名，职称Signature签名Date日期Unit单位Reviewer'sSignature:审查员签名：Yoursignatureindicatesthat,youhavereviewedthisdocumentandthatitaccuratelyandcompletelyreflectsthetasksanddeliverablesnecessaryforvalidationofthe<equipmentname>.您的签名表明您已经审阅了这份文件，确认它精确并完全的反映任务和可交付使用对<设备名称>验证的必要。ReviewedBy:经审阅：Typed/PrintedName,Title姓名，职称Signature签名Date日期Unit单位Typed/PrintedName,Title姓名，职称Signature签名Date日期Unit单位Typed/PrintedName,Title姓名，职称Signature签名Date日期Unit单位QualityControl/ComplianceApprover'sSignature:质检/承认签名Yoursignatureindicatesthatthisdocumentcomplieswith<referenceValidationMasterPlan,companystandardsorguidelines>;andthatthedocumentationandinformationcontainedhereincomplieswithapplicableregulatory,corporate,divisional/departmentalrequirements,andcurrentGoodManufacturingPractices.您的签名表明这份文件符合〈证明人验证总计划，企业标准或政策〉，并且在此包含的文件和信息符合可应用的可调整的，共同的以及部门所有的／部门的要求和现行的ＧＭＰ标准。ApprovedBy:经核准：Typed/PrintedName,Title姓名，职称Signature签名Date日期Unit单位Typed/PrintedName,Title姓名，职称Signature签名Date日期Unit单位

RevisionHistory修订历史纪录Revision修订本RevisionDate修订日期ReasonforRevision/ChangeRequest修订/更改要求的原因RevisedBy修订人004-DEC-20022002/12/4OriginalRelease原始版本MichaelT.Filary迈克尔116-JAN-20032003/1/16UpdatedtheJETTlogoonthecoverpage.更新封页面的JETT的标识MichaelT.Filary迈克尔TableofContents目录TOC\o"1-2"1. Introduction绪论 51.1 Purpose目的 51.2 PolicyCompliance适用的政策 51.3 ScopeofValidation验证范围 51.4 Objectives目标 61.5 PeriodicReview定期审查 62. OrganizationalStructure组织结构 73. GxPCriticalityAssessmentGxP关键性评估 73.1 GxPCriticalityAssessment-RequirementsGxP关键性评估——要求 73.2 GxPCriticalityAssessment-ProceduresGxP关键性评估——程序83.3 GxPCriticalityAssessment–CurrentStatusGxP关键性评估——现行标准 84. ValidationStrategy验证策略 94.1 LifeCycle生命周期 94.2 RiskAssessment风险评估 94.3 HardwareCategories硬件分类 94.4 SoftwareCategories软件分类 94.5 ProjectInputs/OutputsforStages项目各阶段的输入/输出 104.6 AcceptanceCriteriaforStages各阶段的接受标 105. ValidationDeliverables 105.1 TraceabilityandLinkages描述和链接115.2 MasterListofallValidationProductsandSupportingDocumentation所有批准产品和证明文件的总清单115.3 UserRequirementsSpecification(URS)使用说明书 115.4 FunctionalRequirementSpecification(FRS)功能说明书 115.5 ConfigurationManagementandChangeControlDocumentation配置管理和变速控制文件115.6 VendorQualificationdocumentation卖主资格认证115.7 DesignSpecifications设计说明 125.8 TestingandVerificationRequirementsDocumentation试验和确认所需文件 125.9 SystemSecurity系统安全性 135.10 OperationalSupport运行支持 145.11 BusinessContinuityPlan业务持续计划 145.12 DisasterRecovery,BackupandRestoration灾难性恢复，备份及修复 145.13 SystemAcceptance–FinalReport系统接受――终报告 145.14 <Listanyadditionalvalidationproductsrequired>列出任何其他需要验证的产品 156. AcceptanceCriteria可接受标准 157. ChangeControl变更控制 157.1 Pre-ImplementationChanges预执行变更 157.2 Post-ImplementationChanges执行后变更 158. StandardOperatingProceduresSOP 158.1 SOPResponsibilitiesSOP职责 158.2 ListingofSOPsSOP列表 169. Training培训 1610. DocumentationManagement资料管理 1610.1 DocumentProduction文件产生 1610.2 DocumentReview文件回顾 1610.3 DocumentApproval文件批准 1610.4 DocumentIssue文件发布 1610.5 DocumentChanges文件变更 1710.6 DocumentWithdraw文件撤销 1710.7 DocumentStorage文件保存 1711. MaintainingtheValidatedState验证状态的维护 1711.1 SystemRetirement系统引退 1712. ValidationActivitiesTimeline验证执行时间表 17AppendixA附录A参与组织 18AppendixB附录B缩写词，定义 19AppendixC附录C责任/时间 22AppendixD附录D可交付的验证 23AppendixE附录E参考 24(ReminderofPageIntentionallyLeftBlank)

Introduction绪论Purpose目的Thisdocument,alsoreferredtoasthePlan,outlinestheplannedtasksandexpectationsforvalidationofthe<equipmentname>.这份文件，也称计划，略述计划的任务和〈设备名称〉的预期验证。WHOwillberesponsibleforcompletion,review,andapprovalofthesetasks.世界卫生组织将负责任务的完成、审阅和批准。WHATdocumentation/deliverableswillbegeneratedand/orretainedaspartoftheValidationPackage(s).什么文件/可交付使用的将会作为验证包的一部分被产生和/或保留。HOWthisdocumentationwillbeproduced/created(atamacrolevel).这份文件将被如何制作/产生（在宏观上）。PolicyCompliance遵守政策ThisPlanisbeingwrittentocomplywithcorporatepolicyrequirementsforvalidationasstatedinthe<refertospecificValidationMasterPlan(s),companypolicies,companystandards,and/orcompanyguidelines>,andtheappropriateAppendixofthecurrentrevisionofGAMP.这份计划将会遵守在〈涉及特殊验证总计划，公司政策，公司标准和公司指导方针〉和适当性（现行GAMＰ附录）中关于验证的统一要求。Thevalidationofthe<equipmentname>systemisacGMPrequirement.《设备名称》的验证系统是现行ＧＭＰ的一个要求。ScopeofValidation验证范围ThisValidationPlanforthe<equipmentname>islimitedtotheuniquecomponentsandcontrolsystemthatdefinetheequipment.Thisvalidationeffortwillbeconductedasaprospectivevalidation.这份为〈设备名称〉的验证计划仅限于特殊构成和定义设备的控制系统。该项验证成就将会被作为一项预期的验证执行。ProvideaBriefdescriptionofequipmentandprincipalfunction;RefertoUserRequirementSpecifications.Provideadescriptionoftheresearch,manufacturing,processing,packaging,holding,ordistributionprocessforwhichtheequipmentisplanned.对用户必备使用的说明书中的设备和主要功能的阐述.对实施计划的设备进行研究、生产、加工、包装、存储、分配过程的说明。In-Scope验证范围Thescopeofvalidationforthe<equipmentname>includesallthefollowingthatarenecessaryforthesystemtooperate.<clearlydefineallboundaries>（设备名称）验证的范围包括以下所有的系统运作所必需的内容。（明确界限）Controlssystemhardwareandsoftware控制系统得硬件和软件MechanicalHardware机械的硬件Instrumentation仪器Processpiping输水管道工艺UtilitySystems通用系统Facility设施<listallthatareappropriate>其他需要的名单Out-of-Scope验证范围例外Thescopeofvalidationforthe<equipmentname>doesnotinclude:（设备名称）验证的范围不包括：TheXYZsystemisvalidatedseparately.ＸＹＺ系统单独验证TheDataHistorianisvalidatedseparately.数据历史单独验证<listallthatareappropriate>其他名单RelatedValidation相关验证<Insertadescriptionofanyexistingorplannedvalidationthatisrelevanttothevalidationofthissystem.Theuseofpriordatamaybeconsideredeitherasreferencefortestmethodsordirectlyreplacingtests,ifthesystemsconfigurationcanbeshowntobethesamenowasatthetimethedatawascollected>插入现有的或计划的与本验证系统有关的验证的描述。如果系统配置和数据采集时是一致的，前期数据的使用可以作为试验方法的参考或直接替代试验，Therelatedvalidationthatwilloccurinsupportofthe<equipmentname>includesallthefollowingthatarenecessaryforthesystemtobeplacedintooperation.<clearlydefineallboundaries>支持（设备名称）的相关验证在以下情况发生：包括系统运行必需的几点（清晰的定义分界线）：ProcessValidation工艺验证CleaningStudies清洁研究AirClassification风力分级MicrobiologicalTesting微生物试验ChemicalTesting化学试验DryingStudies干燥研究SterilizationStudies无菌研究<listallthatareappropriate>其他名单Objectives目标Theobjectiveofthisvalidationplanistooutlinetherequirementsthatwilldemonstrateanddocumentthatallcomponents,controlsystem(s)andfunctionalityassociatedwiththe<equipmentname>areappropriateforcGMP-regulatedprocesses.Thequalificationsoutlinedaretobebasedon<companyname>policiesandproceduresandapplicableregulations,guidelines,andacceptedindustrypracticesforvalidation.该项验证计划的目标是简述一项要求，该要求能够证明所有与设备名称相关的组成、控制系统和功能都是恰当的符合现行ＧＭＰ标准的工艺。资格的综述要基于（公司名称）政策，程序以及可应用的规则、指导方针和公认的工业验证实践。PeriodicReview定期回顾ThisPlanshouldbereviewedperiodicallytoensurecomplianceandortodetermineifachangeisrequired.Someappropriatetimestorevieware:这份计划应该被定期回顾来保证符合并确定是否需要更改。一些适当的回顾时间是：ChangeinValidationMasterPlan验证主文件的更改发生时Changeinscopeoccurs验证范围的更改发生时Designchangeoccurs设计更改发生时PriortoIQandOQ在进行ＩＱ和ＯＱ之前CompletionofIQandOQＩＱ和ＯＱ完成时Seesection5foradescriptionofValidationManagementandtheprocessforreviewandrevisionstothisplanorrefertotheapplicablecorporatepolicyreviewcycle.见第五部分有关验证管理和针对该项计划的回顾、修订过程或指适应公司政策的回顾周期。2.OrganizationalStructure组织结构Specificresponsibilitiesrelatedtothevalidationofthe<equipmentname>areoutlinedinAppendixA.Ingeneral,theactivitiesassociatedwiththisproject,aretheresponsibilityofthefollowingindividualsandgroups:与（设备名称）验证相关的具体职责在附录Ａ中概述。大体上，与验证相关的活动项目由以下个人和部门负责：<Thedefinedroleandresponsibilitiesshouldincludeataminimumtheindividualslistedbelow-Describeeachroleandresponsibilityinageneralwayastheyapply>确定个人的任务和责任至少应包括以下几点，总体根据岗位不同描述每项任务和责任Managementlevel–Responsibleforprojectmanagementandplanning,controlofprojectactivities/resources/costs,monitoringprocess,initiatingcorrectiveaction,ensuringissues/projectobjectivesarecorrectlyaddressed/resolved,reportingtoseniormanagement,interfacetoQAtoensurecompliance,reviewingandapprovingvalidationdocumentationfortheproject…管理层：负责项目管理和计划。方案，活动，资源，成本的控制，监控工艺，QualityAssurance–Responsibleforassuringcompliancewithappropriateregulatory/business/technical/usercommunityrequirements,providingsupportforthecriterion/independentreview/approvalofdeliverables,approvingcompletionofstage/validationstatus…质保：负责保证符合适当的调整、商业、技术、用户群要求，支持维护标准、独立审查、可交付的批准、审批完成阶段和身份验证等。SystemOwner–Responsibleforimplementation/managementofthesystembythebusinessusercommunity,approvingcompletionofstage/validationstatus…系统所有者：负责执行和管理系统的用户群，审批完成阶段和验证身份。<Theseroleandresponsibilitiesmaybedefinedasappropriate-Describeeachroleandresponsibilityinageneralwayastheyapply>这些任务和责任可以适当的定义：按照他们的分工总体上定义每项任务和责任。Operations–Responsibleforproviding…操作：负责提供…ProjectLevel–Responsibleforproviding…项目水平：负责提供…TechnicalandEngineeringsupport–Responsibleforproviding…技术和工程支持：负责提供…ValidationSpecialist–Responsibleforproviding…验证专家：负责提供…SystemAdministrator–Responsibleforproviding…系统管理：负责提供…Purchasing-Responsibleforproviding…采供：负责提供…<Listallthatareappropriate>其他名单3.GxPCriticalityAssessmentGxP关键性估计DetailtheGxPcriticalityassessmentinformationrelatedtothe<equipmentname>.Thissectionmayreferenceanothersourceofinformationcoveringthistopic,suchasasysteminventory.详述和（设备名称）有关的GxP关键性估计信息。该部分包括另外一种信息，包括该主题，例如系统详细目录。3.1GxPCriticalityAssessment–RequirementsGxP关键性评估——要求DefinetherequirementsusedinthedeterminationofthelevelsforGxPcriticalityforthe<equipmentname>.TherequirementsfordeterminationofthelevelsforGxPcriticalitymayincludeDirectImpact,IndirectImpact,andNoImpactsystems.定义在决定（设备名称）Gxp水平中使用的关键性要求，包括直接影响，间接影响和无影响系统。DirectImpact–Systemorcomponentwithinasystemwheretheoperation,contact,data,control,alarm,orfailurewillhaveadirectimpactonproductquality.直接影响：系统或系统中的一个组成，对产品质量有直接影响的操作，接触，控制，预警或失败。IndirectImpact–Systemorcomponentwithinasystemwheretheoperation,contact,data,control,alarm,orfailurewillnothaveadirectimpactonproductquality.IndirectImpactsystemstypicallysupportDirectImpactsystems,thusindirectimpactsystemmayhaveanaffectontheperformanceoroperationofadirectimpactsystem.间接影响：系统或系统中的一个组成，对产品质量无直接影响的操作，接触，控制，预警或失败。间接影响系统专门支持直接影响系统，因此间接影响系统会对直接影响系统的执行和运作构成影响。NoImpact–Systemorcomponentwithinasystemwheretheoperation,contact,data,control,alarm,orfailurewillnothaveadirectorindirectimpactonproductquality.NoImpactsystemswillnotsupportDirectImpactsystems.无影响：系统或系统的一个组成，对产品质量不构成直接或间接影响的操作，接触，控制，预警或失败。无影响系统不能支持直接影响系统。3.2GxPCriticalityAssessment–ProceduresGxP关键性评估-程序Definetheproceduresused/followedintheassessmentofthelevelsforGxPcriticalityforthe<equipmentname>.DevelopadocumentedpaththatwillbefollowedtodeterminethelevelsforGxPcriticalityforeachitemassociatedwiththe<equipmentname>.ItmaybehelpfultodevelopadecisiontreetodemonstratetheoverviewtotheprocessrequiredindetermininglevelsforGxPcriticality.Internalproceduresmaybereferenced,ifavailable.定义使用的程序/（设备名称）的Gxp关键性水平的评估的标准。开发一种具有证明的文件路径，作为（设备名称）GxP关键性水平每一项目的评估标准。创建一个决策树将对在GxP关键性评估中论证工艺的一般观察要求有帮助。如果必要，可以引用国际程序作为参考。3.3GxPCriticalityAssessment–CurrentStatusGxP关键性评估-现行标准StatethecurrentstatusoftheassessmentfortheGxPcriticalitylevelsforthe<equipmentname>.陈述现行（设备名称）的GxP关键性水平评估的要求。TheDirectImpactSystemsassociatedwiththe<equipmentname>includeallthefollowing.<Clearlydevelopsupportingrationale>（设备名称的）直接影响因素包括以下的所有项。（清楚的规定支持理论）Controlssystemhardwareandsoftware-Thishasbeendeemedadirectimpactsystemdueto…控制系统硬件和软件：该项是一个直接影响由于…MechanicalHardware-Thishasbeendeemedadirectimpactsystemdueto…机械硬件：该项是一个直接影响由于…Instrumentation–Thishasbeendeemedadirectimpactsystemdueto…仪器：该项是一个直接影响由于…Processpiping-Thishasbeendeemedadirectimpactsystemdueto…工艺流程：该项是一个直接影响由于…UtilitySystems-Thishasbeendeemedadirectimpactsystemdueto…效用系统：该项是一个直接影响由于…Facility-Thishasbeendeemedadirectimpactsystemdueto…设备：该项是一个直接影响由于…<Listallthatareappropriate>其他名单TheIndirectImpactSystemsassociatedwiththe<equipmentname>includeallthefollowing.<Clearlydevelopsupportingrationale>（设备名称的）间接影响因素包括以下的所有项。（清楚的规定支持原理）Controlssystemhardwareandsoftware-Thishasbeendeemedanindirectimpactsystemdueto…控制系统硬件和软件：该项是一个间接影响由于…MechanicalHardware-Thishasbeendeemedanindirectimpactsystemdueto…机械硬件：该项是一个间接影响由于…Instrumentation–Thishasbeendeemedanindirectimpactsystemdueto…仪器：该项是一个间接影响由于…Processpiping-Thishasbeendeemedanindirectimpactsystemdueto…工艺流程：该项是一个间接影响由于…UtilitySystems-Thishasbeendeemedanindirectimpactsystemdueto…效用系统：该项是一个间接影响由于…Facility-Thishasbeendeemedanindirectimpactsystemdueto…设备：该项是一个间接影响由于…<Listallthatareappropriate>其他名单TheNoImpactSystemsassociatedwiththe<equipmentname>includeallthefollowing.<Clearlydevelopsupportingrationale>（设备名称的）无影响因素包括以下的所有项。（清楚的规定支持原理）Controlssystemhardwareandsoftware-Thishasbeendeemedanoimpactsystemdueto…控制系统硬件和软件：该项是一个无影响系统由于…MechanicalHardware-Thishasbeendeemedanoimpactsystemdueto…机械硬件：该项是一个无影响系统由于…Instrumentation–Thishasbeendeemedanoimpactsystemdueto…仪器：该项是一个无影响系统由于…UtilitySystems-Thishasbeendeemedanoimpactsystemdueto…工艺流程：该项是一个无影响系统由于…Facility-Thishasbeendeemedanoimpactsystemdueto…设备：该项是一个无影响系统由于…<Listallthatareappropriate>其他名单4.ValidationStrategy验证策略4.1LifeCycle生命周期Definetheinternalrequirementsfordevelopment,testing,delivery,andsupportthatdefinetheperiodoftimethatbeginswhenasystemisconceivedandendswhenthesystemisnolongeravailableforuse.陈述国内研发，测试，运输和维护的要求，定义验证开始的时间段（系统存在时开始），系统结束的时间（系统不可用时结束）。4.2RiskAssessment风险评估StatethecurrentstatusoftheassessmentfortheGxPRiskandBusinessRiskforthe<equipmentname>.Theprocessneedstoaddressthefollowingquestions:陈述现行（设备名称）的GxP关键性水平评估的风险和商业风险。该程序必须包括以下问题：Doesthisautomatedsystemrequirevalidation?自动化系统需要验证吗？Howmuchvalidationisrequiredforthissystem?该系统要求多少验证？Whataspectsofthesystemorprocessarecriticaltoproductandpatientsafety?系统的哪个方面或工艺对产品和患者安全性是关键性因素？Whataspectsofthesystemorprocessarecriticaltobusiness?系统的哪个方面或工艺过程对商业是关键性因素?4.3HardwareCategories硬件分类Definethecategoriesofthehardwareassociatedwiththe<equipmentname>.定义(设备名称)的硬件种类HardwarecomponentsofasystemcanbeanalyzedandcategorizedintooneofthefollowingGAMPdefinedcategories:硬件系统组成可以按照以下GAMP详述的分类方法进行分析和归类：HardwareCategory1–StandardHardwareComponents硬件分类1:标准硬件组成HardwareCategory2–CustomBuiltHardwareComponents硬件分类2：定制的硬件组成4.4SoftwareCategories软件分类Definethecategoriesofthesoftwareassociatedwiththe<equipmentname>.定义(设备名称)的软件种类SoftwarecomponentsofasystemcanbeanalyzedandcategorizedintooneofthefollowingGAMPdefinedcategories:软件系统组成可以按照以下GAMP详述的分类方法进行分析和归类：SoftwareCategory1–OperatingSystems软件分类1：运行系统SoftwareCategory2–Firmware软件分类2：固件（软件硬件相结合）SoftwareCategory3–StandardSoftwarePackages软件分类3：标准软件包SoftwareCategory4–ConfigurableSoftwarePackages软件分类4：结构软件包SoftwareCategory5–CustomSoftware软件分类5：定制软件4.5ProjectInputs/OutputsforStages项目各阶段的输入/输出Definetheprojectinputandoutputsforeachstageoftheprojectassociatedwiththe<equipmentname>.详述（设备名称）的相关项目每一阶段的的输入/输出4.6AcceptanceCriteriaforStages各阶段的接受标准Definetheacceptancecriteriaforeachstageoftheprojectassociatedwiththe<equipmentname>.详述（设备名称）的相关项目各阶段的接受标准。5.ValidationDeliverables验证可交付性ThebalanceofthisPlanoutlinesspecificvalidationactivitiesandproductsthatwillbecreatedandassembledthroughoutthesystemdevelopmentlifecycleandcollectivelywillcomprisetheValidationPackage.ThePlancanserveasanoverviewor"roadmap"totheindividualvalidationproductsasspecifiedbythe<applicablecorporatepolicy>.Additionaldetail,includingimplementationinformation,canbefoundintheindividualproductsthemselves.该计划的平衡略述产生和聚集于系统开发的整个生命过程中的具体的验证活动和产品，包含验证包。该计划可以作为对公司适用政策中规定的个别验证产品的一个回顾或路线图。补充细节，包括执行信息，可以在个别产品中找到。

5.1TraceabilityandLinkages描述和链接ThisdocumentlinkstheURS,FRS,DesignSpecificationsandtheTestingSpecifications(IQ,OQ,PQ)pertheV-Model这份文件像下面所示的V模型一样与URS,FRS,设计阐述和检测说明(IQ,OQ,PQ)链接UserRequirementsSpecificationUserRequirementsSpecification使用要求PerformanceQualificationVerifies证实Verifies证实使用者的需求说明执行条件OperationalQualificationFunctionalOperationalQualificationFunctionalSpecificationsVerifies证实Verifies证实功能阐述运作条件InstallationQualificationDesignSpecificationsInstallationQualificationDesignSpecificationsVerifies证实Verifies证实设计阐述设立条件BuildSystemBuildSystem构筑体系5.2MasterListofallValidationProductsandSupportingDocumentation所有批准产品和证明文件的总清单5.3UserRequirementsSpecification(URS)使用说明书Thisdocumentdescribeswhattheequipmentisintendedtodoandallessentialrequirementssuchasproductionrates,operatingranges,etc.Itisusuallydevelopedbytheowner.ThisdocumentlinkstothePQdocumentwhichtestsforeachoftherequirements.此文件描述了仪器的用途，和对使用率，操作范围等的主要要求，通常是仪器的持有者对其进行改进，此文件与对各项要求进行测试的PQ文件相结合。5.4FunctionalRequirementSpecification(FRS)功能说明书Thisdocumentdescribesthedetailedfunctionalityoftheequipment.Itisusuallydevelopedbythesupplier.ThisdocumentislinkedtotheOQdocumentwhichtestsforeachfunction.次文件对仪器详细功能进行的了描绘，通常是仪器供应商对其进行改进，此文件与检测各项功能的OQ文件相结合。5.5ConfigurationManagementandChangeControlDocumentation配置管理和变速控制文件Changecontrolisaformalprocessbywhichqualifiedrepresentativesofappropriatedisciplinesreviewproposedoractualchangesthatmightaffectavalidatedand/orapprovedstatus.Theintentistodeterminetheneedforactionthatwouldensureanddocumentthatthesystemmaintainsthisstatus.Thisprocessdocumentsthepre-implementationchangesandpost-implementationchanges.DocumentsthatrequirechangecontrolmayincludeanyoftheValidationProductslistedinsection5.变化控制是正式的程序，是根据适当的重复检测而得出的有代表性的检测而提出的。其目的是决定操作规程和保持系统稳定的文件。这个程序为变速前后的安装启用提供证明。要求执行变速控制的文件应该包括第5部分目录中任何一个合格产品。5.6VendorQualificationdocumentation卖主资格认证Providedocumentationthatverifiesthatvendor(s)arequalified,competentandexperienced.提供文件来证实卖主是有资格的，有能力的，有经验的5.7DesignSpecifications设计说明Includeanydocumentsrequiredtosupportinstallation.(Thefollowingdocumentsareexamples,butarenotmeanttobeanexclusivelist).包括所有需要支持安装装置的文件。（以下文件供参考，但不是完整清单）Detailedprocessdescriptions,narratives,andsequenceofoperations详细的工艺种类，描述和操作性的Subsystemdefinitions子系统得定义DataFlowDiagrams流程表数据ProcessFlowDiagrams工艺流程数据Systemarchitecturedra系统建筑学数据Pipingandinstrumentationdiagrams管道和仪器图表Controlwiringdiagrams控制配线图表Powerdistributionandgroundingdiagrams分销能力和基地表Panellayoutdrawings设计图纸Hardwareandsoftwaredesignspecifications硬件和软件设计说明书Billofmaterials物料清单Otherdocumentsrequiredforinstallation,operationsandmaintenance其他安装，运行和维护文件5.7.1TraceabilityMatrix矩阵描述Thetraceabilityofcriticalparametersanddatathroughthedesignprocesstothefinaltestingstagewillbemaintainedusingamatrix.Thismatrixshalldetailallcriticalequipmentandsoftwareparametersandlinkthemtotheirindividualtestcasesandthedocumentinwhichtheyappear.Therequirementstraceabilitymatrixshallbemaintainedunderchangecontrolforthelifeoftheequipment.从设计阶段到最终的测试阶段的重要参数和数据的描述应该用矩阵来表示。这个矩阵应该详述所有的关键设备和软件的参数，并链接到他们各自所在的检测文件中。需求量的描述应该维持在设备寿命变化控制以下。Author'sSignature:Yoursignatureindicatesthatthisdocumenthasbeenpreparedinaccordancewithexistingprojectstandardsandadequatelyreflectsthetasksanddeliverablesnecessaryforvalidationofthe<equipmentname>AuthoredBy:Typed/PrintedName,TitleSignatureDateUnitReviewer'sSignature:Yoursignatureindicatesthat,youhavereviewedthisdocumentandthatitaccuratelyandcompletelyreflectsthetasksanddeliverablesnecessaryforvalidationofthe<equipmentname>.ReviewedBy:Typed/PrintedName,TitleSignatureDateUnitTyped/PrintedName,TitleSignatureDateUnitTyped/PrintedName,TitleSignatureDateUnitQualityControl/ComplianceApprover'sSignature:Yoursignatureindicatesthatthisdocumentcomplieswith<referenceValidationMasterPlan,companystandardsorguidelines>;andthatthedocumentationandinformationcontainedhereincomplieswithapplicableregulatory,corporate,divisional/departmentalrequirements,andcurrentGoodManufacturingPractices.ApprovedBy:Typed/PrintedName,TitleSignatureDateUnitTyped/PrintedName,TitleSignatureDateUnit

RevisionHistoryRevisionRevisionDateReasonforRevision/ChangeRequestRevisedByA02001.03.04-DEC-200220OriginalDraftReleaseMichaelT.FilaryBruceLauderman116-JAN-2003UpdatedtheJETTlogoonthecoverpage.MichaelT.Filary

TableofContentsTOC\o"1-2"1. Introduction 51.1 Purpose 51.2 PolicyCompliance 51.3 ScopeofValidation 51.4 Objectives 61.5 PeriodicReview 62. OrganizationalStructure 73. GxPCriticalityAssessment 73.1 GxPCriticalityAssessment-Requirements 73.2 GxPCriticalityAssessment-Procedures 83.3 GxPCriticalityAssessment–CurrentStatus 84. ValidationStrategy 94.1 LifeCycle 94.2 RiskAssessment 94.3 HardwareCategories 94.4 SoftwareCategories 94.5 ProjectInputs/OutputsforStages 104.6 AcceptanceCriteriaforStages 105. ValidationDeliverables 105.1 TraceabilityandLinkages 115.2 MasterListofallValidationProductsandSupportingDocumentation 115.3 UserRequirementsSpecification(URS) 115.4 FunctionalRequirementSpecification(FRS) 115.5 ConfigurationManagementandChangeControlDocumentation 115.6 VendorQualificationdocumentation 115.7 DesignSpecifications 125.8 TestingandVerificationRequirementsDocumentation 125.9 SystemSecurity 135.10 OperationalSupport 145.11 BusinessContinuityPlan 145.12 DisasterRecovery,BackupandRestoration 145.13 SystemAcceptance–FinalReport 145.14 <Listanyadditionalvalidationproductsrequired> 156. AcceptanceCriteria 157. ChangeControl 157.1 Pre-ImplementationChanges 157.2 Post-ImplementationChanges 158. StandardOperatingProcedures 158.1 SOPResponsibilities 158.2 ListingofSOPs 169. Training 1610. DocumentationManagement 1610.1 DocumentProduction 1610.2 DocumentReview 1610.3 DocumentApproval 1610.4 DocumentIssue 1610.5 DocumentChanges 1710.6 DocumentWithdraw 1710.7 DocumentStorage 1711. MaintainingtheValidatedState 1711.1 SystemRetirement 1712. ValidationActivitiesTimeline 17AppendixA 18AppendixB 19AppendixC 22AppendixD 23AppendixE 241. Introduction 51.1 Purpose 51.2 PolicyCompliance 51.3 ScopeofValidation 51.4 Objectives 71.5 PeriodicReview 72. RolesandResponsibilities 83. SystemDescription 83.1 GeneralOverviewofEquipment 83.2 GeneralOverviewofEnvironment 84. ValidationManagement 94.1 Approach 94.2 ChangeManagement 94.3 RecordManagement 95. ValidationProductRequirements 1095.1 UserRequirementsSpecification(URS) 105.2 FunctionalRequirementSpecification(FRS) 105.3 ChangeManagementDocumentation 105.4 VendorQualificationdocumentation 105.5 DesignSpecifications 11105.6 TraceabilityandLinkages 12115.7 TestingRequirementsDocumentation 12115.8 TrainingRequirementsDocumentation 13125.9 SystemSecurity 14125.10 OperationalSupport 14125.11 BusinessContinuityPlan 15145.12 SystemAcceptance–FinalReport 15145.13 Anyadditionalvalidationproductsrequired 15146. ValidationActivitiesTimeline 1514AppendixA 1715AppendixB 1816AppendixC 2119AppendixD 2220(ReminderofPageIntentionallyLeftBlank)

IntroductionPurposeThisdocument,alsoreferredtoasthePlan,outlinestheplannedtasksandexpectationsforvalidationofthe<equipmentname>.WHOwillberesponsibleforcompletion,review,andapprovalofthesetasks.WHATdocumentation/deliverableswillbegeneratedand/orretainedaspartoftheValidationPackage(s).HOWthisdocumentationwillbeproduced/created(atamacrolevel).PolicyComplianceThisPlanisbeingwrittentocomplywithcorporatepolicyrequirementsforvalidationasstatedinthe<refertospecificValidationMasterPlan(s),n,,companystandardspolicies,companystandards,and/orcompanyorguidelines>,andtheappropriateAppendix6ofofthecurrentrevisionofGAMP3.Thevalidationofthe<equipmentname>systemisacGMPrequirement.ScopeofValidationThisValidationPlanforthe<equipmentname>islimitedtotheuniquecomponentsandcontrolsystemthatdefinethattheequipment.Thisvalidationeffortwillbeconductedasaprospectivevalidation.ProvideaBriefdescriptionofequipmentandprincipalfunction;RefertoUserRequirementSpecifications.Provideadescriptionoftheresearch,manufacturing,processing,packaging,holding,ordistributionprocessforwhichtheequipmentisplanned.ofthe<equipmentname>equipmentname>equipmentname><equipmentname><equipmentname>In-ScopeThescopeofvalidationforthe<equipmentname>includesallthefollowingthatwhicharenecessaryforthesystemtooperate.<clearlydefineallboundaries>ControlssystemhardwareandsoftwareMechanicalHardwareInstrumentat