验证计划模板

Author'sSignature:授权者署名Yoursignatureindicatesthatthisdocumenthasbeenpreparedinaccordancewithexistingprojectstandardsandadequatelyreflectsthetasksanddeliverablesnecessaryforvalidationofthe<equipmentname>您的署名表白这份文献的准备符合现行项目的准并且充足反映人物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署名Date日期Unit单位Reviewer'sSignature:审查员署名：Yoursignatureindicatesthat,youhavereviewedthisdocumentandthatitaccuratelyandcompletelyreflectsthetasksanddeliverablesnecessaryforvalidationofthe<equipmentname>.您的署名表白您已经审阅了这份文献，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署名Date日期Unit单位Typed/PrintedName,Title姓名，职称Signature署名Date日期Unit单位Typed/PrintedName,Title姓名，职称Signature署名Date日期Unit单位QualityControl/ComplianceApprover'sSignature:质检/认可署名Yoursignatureindicatesthatthisdocumentcomplieswith<referenceValidationMasterPlan,companystandardsorguidelines>;andthatthedocumentationandinformationcontainedhereincomplieswithapplicableregulatory,corporate,divisional/departmentalrequirements,andcurrentGoodManufacturingPractices.您的署名表白这份文献符合〈证明人验证总计划，公司标准或政策〉，并且在此包含的文献和信息符合可应用的可调整的，共同的以及部门所有的／部门的规定和现行的ＧＭＰ标准。ApprovedBy:经核准：Typed/PrintedName,Title姓名，职称Signature署名Date日期Unit单位Typed/PrintedName,Title姓名，职称Signature署名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/更改规定的因素RevisedBy修订人004-DEC-20232023/12/4OriginalRelease原始版本MichaelT.Filary迈克尔116-JAN-20232023/1/16UpdatedtheJETTlogoonthecoverpage.更新封页面的JETT的标记MichaelT.Filary迈克尔TableofContents目录TOC\o"1-2"1. Introduction 61.1 Purpose 61.2 PolicyCompliance 61.3 ScopeofValidation 61.4 Objectives 81.5 PeriodicReview 8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。 92.OrganizationalStructure 93.GxPCriticalityAssessment 103.1GxPCriticalityAssessment–Requirements 103.2GxPCriticalityAssessment–Procedures 113.3GxPCriticalityAssessment–CurrentStatus 114.ValidationStrategy 134.1LifeCycle 134.2RiskAssessment 134.3HardwareCategories 134.4SoftwareCategories 144.5ProjectInputs/OutputsforStages 144.6AcceptanceCriteriaforStages 155.ValidationDeliverables 155.1TraceabilityandLinkages 165.2MasterListofallValidationProductsandSupportingDocumentation 165.3UserRequirementsSpecification(URS)使用说明书 165.4FunctionalRequirementSpecification(FRS)功能说明书 165.5ConfigurationManagementandChangeControlDocumentation 175.6VendorQualificationdocumentation 175.7DesignSpecifications 171.6 TestingandVerificationRequirementsDocumentation 181.7 SystemSecurity 191.8 OperationalSupport运营支持 201.9 BusinessContinuityPlan业务连续计划 201.10 DisasterRecovery,BackupandRestoration劫难性恢复，备份及修复 211.11 SystemAcceptance–FinalReport系统接受――终报告 211.12 <Listanyadditionalvalidationproductsrequired>列出任何其他需要验证的产品 212. AcceptanceCriteria可接受标准 213. ChangeControl变更控制 223.1 Pre-ImplementationChanges预执行变更 223.2 Post-ImplementationChanges执行后变更 224. StandardOperatingProceduresSOP 224.1 SOPResponsibilitiesSOP职责 224.2 ListingofSOPsSOP列表 235. Training培训 236. DocumentationManagement资料管理 236.1 DocumentProduction文献产生 236.2 DocumentReview文献回顾 236.3 DocumentApproval文献批准 236.4 DocumentIssue文献发布 246.5 DocumentChanges文献变更 246.6 DocumentWithdraw文献撤消 246.7 DocumentStorage文献保存 247. MaintainingtheValidatedState验证状态的维护 247.1 SystemRetirement系统引退 248. ValidationActivitiesTimeline验证执行时间表 25AppendixA 26AppendixB 27AppendixC 30AppendixD 32AppendixE 34(ReminderofPageIntentionallyLeftBlank)

Introduction绪论Purpose目的Thisdocument,alsoreferredtoasthePlan,outlinestheplannedtasksandexpectationsforvalidationofthe<equipmentname>.这份文献，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毕、审阅和批准。WHATdocumentation/deliverableswillbegeneratedand/orretainedaspartoftheValidationPackage(s).什么文献/可交付使用的将会作为验证包的一部分被产生和/或保存。HOWthisdocumentationwillbeproduced/created(atamacrolevel).这份文献将被如何制作/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）中关于验证的统一规定。Thevalidationofthe<equipmentname>systemisacGMPrequirement.《设备名称》的验证系统是现行ＧＭＰ的一个规定。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重要功能的阐述.对实行计划的设备进行研究、生产、加工、包装、存储、分派过程的说明。In-Scope验证范围Thescopeofvalidationforthe<equipmentname>includesallthefollowingthatarenecessaryforthesystemtooperate.<clearlydefineallboundaries>（设备名称）验证的范围涉及以下所有的系统运作所必需的内容。（明确界线）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）验证的范围不涉及：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。假如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实验方法的参考或直接替代实验，Therelatedvalidationthatwilloccurinsupportofthe<equipmentname>includesallthefollowingthatarenecessaryforthesystemtobeplacedintooperation.<clearlydefineallboundaries>支持（设备名称）的相关验证在以下情况发生：涉及系统运营必需的几点（清楚的定义分界线）：ProcessValidation工艺验证CleaningStudies清洁研究AirClassification风力分级MicrobiologicalTesting微生物实验ChemicalTesting化学实验DryingStudies干燥研究SterilizationStudies无菌研究<listallthatareappropriate>其他名单Objectives目的Theobjectiveofthisvalidationplanistooutlinetherequirementsthatwilldemonstrateanddocumentthatallcomponents,controlsystem(s)andfunctionalityassociatedwiththe<equipmentname>areappropriateforcGMP-regulatedprocesses.Thequalificationsoutlinedaretobebasedon<companyname>policiesandproceduresandapplicableregulations,guidelines,andacceptedindustrypracticesforvalidation.该项验证计划的目的是简述一项规定，该规定可以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:这份计划应当被定期回顾来保证符合并拟定是否需要更改。一些适当的回顾时间是：ChangeinValidationMasterPlan验证主文献的更改发生时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完毕时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>拟定个人的任务和责任至少应涉及以下几点，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、用户群规定，支持维护标准、独立审查、可交付的批准、审批完毕阶段和身份验证等。SystemOwner–Responsibleforimplementation/managementofthesystembythebusinessusercommunity,approvingcompletionofstage/validationstatus…系统所有者：负责执行和管理系统的用户群，审批完毕阶段和验证身份。<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。该部分涉及此外一种信息，涉及该主题，例如系统具体目录。3.1GxPCriticalityAssessment–RequirementsGxP关键性评估——规定DefinetherequirementsusedinthedeterminationofthelevelsforGxPcriticalityforthe<equipmentname>.TherequirementsfordeterminationofthelevelsforGxPcriticalitymayincludeDirectImpact,IndirectImpact,andNoImpactsystems.定义在决定（设备名称）Gxp水平中使用的关键性规定，涉及直接影响，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献途径，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测规定有帮助。假如必要，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关键性水平评估的规定。TheDirectImpactSystemsassociatedwiththe<equipmentname>includeallthefollowing.<Clearlydevelopsupportingrationale>（设备名称的）直接影响因素涉及以下的所有项。（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）间接影响因素涉及以下的所有项。（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）无影响因素涉及以下的所有项。（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，运送和维护的规定，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。该程序必须涉及以下问题：Doesthisautomatedsystemrequirevalidation?自动化系统需要验证吗？Howmuchvalidationisrequiredforthissystem?该系统规定多少验证？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：运营系统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合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，涉及执行信息，可以在个别产品中找到。

5.1TraceabilityandLinkages描述和链接ThisdocumentlinkstheURS,FRS,DesignSpecificationsandtheTestingSpecifications(IQ,OQ,PQ这份文献像下面所示的V模型同样与URS,FRS,设计阐述和检测说明(IQ,OQ,PQ)链接UserRequirementsSpecificationUserRequirementsSpecification使用规定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献的总清单5.3UserRequirementsSpecification(URS)使用说明书Thisdocumentdescribeswhattheequipmentisintendedtodoandallessentialrequirementssuchasproductionrates,operatingranges,etc.Itisusuallydevelopedbytheowner.ThisdocumentlinkstothePQdocumentwhichtestsforeachoftherequirements.此文献描述了仪器的用途，和对使用率，操作范围等的重要规定，通常是仪器的持有者对其进行改善，此文献与对各项规定进行测试的PQ文献相结合。5.4FunctionalRequirementSpecification(FRS)功能说明书Thisdocumentdescribesthedetailedfunctionalityoftheequipment.Itisusuallydevelopedbythesupplier.ThisdocumentislinkedtotheOQdocumentwhichtestsforeachfunction.次文献对仪器具体功能进行的了描绘，通常是仪器供应商对其进行改善，此文献与检测各项功能的OQ文献相结合。5.5ConfigurationManagementandChangeControlDocumentation配置管理和变速控制文献Changecontrolisaformalprocessbywhichqualifiedrepresentativesofappropriatedisciplinesreviewproposedoractualchangesthatmightaffectavalidatedand/orapprovedstatus.Theintentistodeterminetheneedforactionthatwouldensureanddocumentthatthesystemmaintainsthisstatus.Thisprocessdocumentsthepre-implementationchangesandpost-implementationchanges.DocumentsthatrequirechangecontrolmayincludeanyoftheValidationProductslistedinsection5.变化控制是正式的程序，是根据适当的反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献。这个程序为变速前后的安装启用提供证明。规定执行变速控制的文献应当涉及第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.提供文献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).涉及所有需要支持安装装置的文献。（以下文献供参考，但不是完整清单）Detailedprocessdescriptions,narratives,andsequenceofoperations具体的工艺种类，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，运营和维护文献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当用矩阵来表达。这个矩阵应当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献中。需求量的描述应当维持在设备寿命变化控制以下。TestingandVerificationRequirementsDocumentation实验和确认所需文献Testingwillbeperformedinamannertoassure,inacomplete,verifiablemanner,therequirements,design,andcharacteristicsofthesystemanditscomponents.Testingwillincludethefollowing:实验的进行要复合规定、设计、系统特性及其组成。实验要涉及以下方面：Testingdocuments实验文献Thevalidationprojectmayincludeallorpartofthefollowingtestingcomponents(seeAppendixBfordefinitions):验证计划应涉及所有或部分以下的实验内容（见附件B的定义）DQorDesignReviewsDQ或设计回顾FATSATCommissioning指令P&IDchecksoftheequipment仪器的P&ID检测InstallationQualification(IQ)documents安装确认文献IQisthedocumentedverificationthatallkeyaspectsofthehardwareandsoftwareinstallationadheretoappropriatecodesandapproveddesignintentionsandthattherecommendationsofthemanufacturerhavebeensuitablyconsidered.安装确认指的是硬件和软件系统安装中所有关键点的确认，其中软件涉及相关代码和被认可的设计目的以及那些由生产商推荐的通过考虑的部分。AnIQprotocolshallbegenerated,executedandapprovedtoprovidedocumentedevidencethattheequipmentwasinstalledaccordingtothedesignspecificationrequirements.Afinalreportshallbegeneratedsummarizingtheresults.Anyobserveddeficienciesandthecorrectiveactionsaretobeaddressedinthisreport.安装确认计划从其产生、执行到核准，应当可以提供仪器的安装是根据设计规定进行操作的证明证据。OperationQualification(OQ)documents运营确认文献OQisthedocumentedverificationthattheequipment-relatedsystemorsubsystemperformsasspecifiedthroughoutrepresentativeoranticipatedoperatingranges.运营确认是作为运营范围内代表性的或参与其中的设备相关系统或子系统的确认AnOQprotocolshallbegenerated,executedandapprovedtoprovidedocumentedevidencethattheequipmentoperatesaccordingtothefunctionalrequirementspecification.Afinalreportshallbegeneratedsummarizingtheresults.Anyobserveddeficienciesandthecorrectiveactionsaretobeaddressedinthisreport.运营确认计划从其产生、执行到核准，应当可以提供仪器的操作是根据其性能规定执行的证明证据。PerformanceQualification(PQ)documents性能确认文献PQisthedocumentedverificationthattheprocessand/orthetotalprocess-relatedsystemperformsasintendedthroughoutallanticipatedoperatingranges.性能确认是整个操作范围的过程和/或所有过程相关系统的文献确认。APQprotocolshallbegenerated,executedandapprovedtoprovidedocumentedevidencethattheequipmentsatisfiestheuserrequirementspecifications.Afinalreportshallbegeneratedsummarizingtheresults.Anyobserveddeficienciesandthecorrectiveactionsaretobeaddressedinthisreport.性能确认计划从其产生、执行到核准，应当可以提供仪器可以满足使用者使用规定的证明证据。DeviationManagement偏差解决Deviationsarisingduringtestingshallberecordedandbetraceablethroughoutcorrectionandretestintofinalclosureinaccordancewith<insertcompanyprocedure>.实验中出现的偏差应当进行记录并可以追溯改正，再进行实验并根据《公司变更程序》管理制度进行终止。SystemSecurity系统安全性AcomprehensiveSecurityPlanwillbedeveloped.Theplanwilladdressbothphysicalandlogicalsecuritycontrolstobeappliedtotheapplication,andoperatingsystem,storagemedia,equipment,anddocumentation.Anaccesscontrolmatrixwilldefinethevariousclassesofusers,thevariousclassesofdata/information,andtheaccessprivileges(e.g.,create,read,update,delete)foreachcombinationofuseranddata.Application-levelprivilegeswillbespecifiedconsistentwithexistingbusinessareapracticesandprocedures.制定一个安全性综合计划。计划将关注于物理安全性控制和逻辑安全性控制两个方面，应用对象涉及应用系统和操作系统，存储介质，仪器和文献。访问控制矩阵将定义不同类型的用户，不同类型的数据/信息以及对于每一个用户和数据组合的访问权限（比如创建、阅读、更新、删除）。申请级别权限将与现有的商业惯例和程序相一致。TheSecurityPlanwillalsodescribeorreferenceproposedprocessesforauthorizationandadministrationofaccountsfor:安全性计划也可以描述或参照通过授权认可的环节进行OperatingSystem操作系统Applicationmanagementandusageaccountsand/orqualifications申请管理、使用帐户和/或使用权限OperationalSupport运营支持TheOperationalSupportdocumentwillbecomposedofdocumentationandwritteninstructionsforroutine,day-to-dayactivitiesassociatedwithusingandsupportingthisequipmentincludingoperatingranges,cleaningorsanitizing,etc.Writteninstructionswillincludebothenduserinstructionsandtechnicalinstructionsforsystemsupport.Documentsthatwillbedevelopedorreferencedinclude:运营支持文献由以下内容组成：平常工作的书面指令，与设备使用和支持相关的的平常行为，涉及操作范围、清洗或消毒，等等。书面指令涉及最终用户指令和系统支持的技术指令。Installationandmaintenancemanualsforvendor-suppliedequipment设备供应商的安装和维护指南EquipmentOperatingProcedures设备操作程序EquipmentMaintenanceProcedures设备维护程序CleaningProcedures清洁程序SanitizationProcedures消毒程序ApplicationSourceCode应用源程序<Listallapplicabledocumentsthatarecreates,updated,and/orretiredasaresultofthenewequipment>作为新设备替代的结果，列出所有可用文献：创建、更新、和/或废止BusinessContinuityPlan业务连续计划Abusinessimpactassessment(BIA)forthe<equipmentname>willbeconductedtoidentifytheinformationalassetsofthesystemandtoevaluatethecriticalityofthoseassetsnotbeingavailable.BasedontheresultsoftheBIA,aBusinessContinuityPlan(BCP)willbedeveloped.Thisplanwillincludeorreference:固定资产的业务影响分析是用来拟定系统的信息资产以及信息资产在不能使用时所导致的危害限度。基于业务影响分析结果的基础上形成业务连续计划。计划应当涉及或参考以下内容：Recoveryplansforcomputerizedsystemsandassociatedequipment计算机化系统和相关仪器的恢复计划Businessprocedurestofollowinordertocontinueoperation(includingpossibleinterimmanualoperations)继续操作的业务程序（涉及也许的过渡手册操作）Amethodtocapturedataforre-entryintothesystemafterrecovery恢复后重新进入系统可以保证获得数据的方法Theresourcesneededfortheabovenamedactivitiesincluding:以上提到的行为来源涉及Hardwareinventories硬件具体目录Softwareinventoriesandconfiguration软件具体目录和配置NetworkSe