翻譯后的計(jì)算機(jī)化系統(tǒng)驗(yàn)證模板

CompanyLogo###-##NUM-Aug-200220-Mar-2001

Author'sSignature:授權(quán)者簽名Yoursignatureindicatesthatthisdocumenthasbeenpreparedinaccordancewithexistingprojectstandardsandadequatelyreflectsthetasksanddeliverablesnecessaryforvalidationofthe<equipmentname>您的簽名表明這份文件的準(zhǔn)備符合現(xiàn)行項(xiàng)目標(biāo)準(zhǔn)并且充分反映人物u和可交付使用對(duì)<設(shè)備名稱>驗(yàn)證的必要。AuthoredBy:經(jīng)授權(quán)：Typed/PrintedName,Title姓名，職稱Signature簽名Date日期Unit單位Reviewer'sSignature:審查員簽名：Yoursignatureindicatesthat,youhavereviewedthisdocumentandthatitaccuratelyandcompletelyreflectsthetasksanddeliverablesnecessaryforvalidationofthe<equipmentname>.您的簽名表明您已經(jīng)審閱了這份文件，確認(rèn)它精確并完全的反映任務(wù)和可交付使用對(duì)<設(shè)備名稱>驗(yàn)證的必要。ReviewedBy:經(jīng)審閱：Typed/PrintedName,Title姓名，職稱Signature簽名Date日期Unit單位Typed/PrintedName,Title姓名，職稱Signature簽名Date日期Unit單位Typed/PrintedName,Title姓名，職稱Signature簽名Date日期Unit單位QualityControl/ComplianceApprover'sSignature:質(zhì)檢/承認(rèn)簽名Yoursignatureindicatesthatthisdocumentcomplieswith<referenceValidationMasterPlan,companystandardsorguidelines>;andthatthedocumentationandinformationcontainedhereincomplieswithapplicableregulatory,corporate,divisional/departmentalrequirements,andcurrentGoodManufacturingPractices.您的簽名表明這份文件符合〈證明人驗(yàn)證總計(jì)劃，企業(yè)標(biāo)準(zhǔn)或政策〉，并且在此包含的文件和信息符合可應(yīng)用的可調(diào)整的，共同的以及部門所有的／部門的要求和現(xiàn)行的ＧＭＰ標(biāo)準(zhǔn)。ApprovedBy:經(jīng)核準(zhǔn)：Typed/PrintedName,Title姓名，職稱Signature簽名Date日期Unit單位Typed/PrintedName,Title姓名，職稱Signature簽名Date日期Unit單位

RevisionHistory修訂歷史紀(jì)錄Revision修訂本RevisionDate修訂日期ReasonforRevision/ChangeRequest修訂/更改要求的原因RevisedBy修訂人004-DEC-20022002/12/4OriginalRelease原始版本MichaelT.Filary邁克爾116-JAN-20032003/1/16UpdatedtheJETTlogoonthecoverpage.更新封頁(yè)面的JETT的標(biāo)識(shí)MichaelT.Filary邁克爾TableofContents目錄TOC\o"1-2"1. Introduction緒論 51.1 Purpose目的 51.2 PolicyCompliance適用的政策 51.3 ScopeofValidation驗(yàn)證范圍 51.4 Objectives目標(biāo) 61.5 PeriodicReview定期審查 62. OrganizationalStructure組織結(jié)構(gòu) 73. GxPCriticalityAssessmentGxP關(guān)鍵性評(píng)估 73.1 GxPCriticalityAssessment-RequirementsGxP關(guān)鍵性評(píng)估——要求 73.2 GxPCriticalityAssessment-ProceduresGxP關(guān)鍵性評(píng)估——程序83.3 GxPCriticalityAssessment–CurrentStatusGxP關(guān)鍵性評(píng)估——現(xiàn)行標(biāo)準(zhǔn) 84. ValidationStrategy驗(yàn)證策略 94.1 LifeCycle生命周期 94.2 RiskAssessment風(fēng)險(xiǎn)評(píng)估 94.3 HardwareCategories硬件分類 94.4 SoftwareCategories軟件分類 94.5 ProjectInputs/OutputsforStages項(xiàng)目各階段的輸入/輸出 104.6 AcceptanceCriteriaforStages各階段的接受標(biāo) 105. ValidationDeliverables 105.1 TraceabilityandLinkages描述和鏈接115.2 MasterListofallValidationProductsandSupportingDocumentation所有批準(zhǔn)產(chǎn)品和證明文件的總清單115.3 UserRequirementsSpecification(URS)使用說(shuō)明書 115.4 FunctionalRequirementSpecification(FRS)功能說(shuō)明書 115.5 ConfigurationManagementandChangeControlDocumentation配置管理和變速控制文件115.6 VendorQualificationdocumentation賣主資格認(rèn)證115.7 DesignSpecifications設(shè)計(jì)說(shuō)明 125.8 TestingandVerificationRequirementsDocumentation試驗(yàn)和確認(rèn)所需文件 125.9 SystemSecurity系統(tǒng)安全性 135.10 OperationalSupport運(yùn)行支持 145.11 BusinessContinuityPlan業(yè)務(wù)持續(xù)計(jì)劃 145.12 DisasterRecovery,BackupandRestoration災(zāi)難性恢復(fù)，備份及修復(fù) 145.13 SystemAcceptance–FinalReport系統(tǒng)接受――終報(bào)告 145.14 <Listanyadditionalvalidationproductsrequired>列出任何其他需要驗(yàn)證的產(chǎn)品 156. AcceptanceCriteria可接受標(biāo)準(zhǔn) 157. ChangeControl變更控制 157.1 Pre-ImplementationChanges預(yù)執(zhí)行變更 157.2 Post-ImplementationChanges執(zhí)行后變更 158. StandardOperatingProceduresSOP 158.1 SOPResponsibilitiesSOP職責(zé) 158.2 ListingofSOPsSOP列表 169. Training培訓(xùn) 1610. DocumentationManagement資料管理 1610.1 DocumentProduction文件產(chǎn)生 1610.2 DocumentReview文件回顧 1610.3 DocumentApproval文件批準(zhǔn) 1610.4 DocumentIssue文件發(fā)布 1610.5 DocumentChanges文件變更 1710.6 DocumentWithdraw文件撤銷 1710.7 DocumentStorage文件保存 1711. MaintainingtheValidatedState驗(yàn)證狀態(tài)的維護(hù) 1711.1 SystemRetirement系統(tǒng)引退 1712. ValidationActivitiesTimeline驗(yàn)證執(zhí)行時(shí)間表 17AppendixA附錄A參與組織 18AppendixB附錄B縮寫詞，定義 19AppendixC附錄C責(zé)任/時(shí)間 22AppendixD附錄D可交付的驗(yàn)證 23AppendixE附錄E參考 24(ReminderofPageIntentionallyLeftBlank)

Introduction緒論P(yáng)urpose目的Thisdocument,alsoreferredtoasthePlan,outlinestheplannedtasksandexpectationsforvalidationofthe<equipmentname>.這份文件，也稱計(jì)劃，略述計(jì)劃的任務(wù)和〈設(shè)備名稱〉的預(yù)期驗(yàn)證。WHOwillberesponsibleforcompletion,review,andapprovalofthesetasks.世界衛(wèi)生組織將負(fù)責(zé)任務(wù)的完成、審閱和批準(zhǔn)。WHATdocumentation/deliverableswillbegeneratedand/orretainedaspartoftheValidationPackage(s).什么文件/可交付使用的將會(huì)作為驗(yàn)證包的一部分被產(chǎn)生和/或保留。HOWthisdocumentationwillbeproduced/created(atamacrolevel).這份文件將被如何制作/產(chǎn)生（在宏觀上）。PolicyCompliance遵守政策ThisPlanisbeingwrittentocomplywithcorporatepolicyrequirementsforvalidationasstatedinthe<refertospecificValidationMasterPlan(s),companypolicies,companystandards,and/orcompanyguidelines>,andtheappropriateAppendixofthecurrentrevisionofGAMP.這份計(jì)劃將會(huì)遵守在〈涉及特殊驗(yàn)證總計(jì)劃，公司政策，公司標(biāo)準(zhǔn)和公司指導(dǎo)方針〉和適當(dāng)性（現(xiàn)行GAMＰ附錄）中關(guān)于驗(yàn)證的統(tǒng)一要求。Thevalidationofthe<equipmentname>systemisacGMPrequirement.《設(shè)備名稱》的驗(yàn)證系統(tǒng)是現(xiàn)行ＧＭＰ的一個(gè)要求。ScopeofValidation驗(yàn)證范圍ThisValidationPlanforthe<equipmentname>islimitedtotheuniquecomponentsandcontrolsystemthatdefinetheequipment.Thisvalidationeffortwillbeconductedasaprospectivevalidation.這份為〈設(shè)備名稱〉的驗(yàn)證計(jì)劃僅限于特殊構(gòu)成和定義設(shè)備的控制系統(tǒng)。該項(xiàng)驗(yàn)證成就將會(huì)被作為一項(xiàng)預(yù)期的驗(yàn)證執(zhí)行。ProvideaBriefdescriptionofequipmentandprincipalfunction;RefertoUserRequirementSpecifications.Provideadescriptionoftheresearch,manufacturing,processing,packaging,holding,ordistributionprocessforwhichtheequipmentisplanned.對(duì)用戶必備使用的說(shuō)明書中的設(shè)備和主要功能的闡述.對(duì)實(shí)施計(jì)劃的設(shè)備進(jìn)行研究、生產(chǎn)、加工、包裝、存儲(chǔ)、分配過(guò)程的說(shuō)明。In-Scope驗(yàn)證范圍Thescopeofvalidationforthe<equipmentname>includesallthefollowingthatarenecessaryforthesystemtooperate.<clearlydefineallboundaries>（設(shè)備名稱）驗(yàn)證的范圍包括以下所有的系統(tǒng)運(yùn)作所必需的內(nèi)容。（明確界限）Controlssystemhardwareandsoftware控制系統(tǒng)得硬件和軟件MechanicalHardware機(jī)械的硬件Instrumentation儀器Processpiping輸水管道工藝UtilitySystems通用系統(tǒng)Facility設(shè)施<listallthatareappropriate>其他需要的名單Out-of-Scope驗(yàn)證范圍例外Thescopeofvalidationforthe<equipmentname>doesnotinclude:（設(shè)備名稱）驗(yàn)證的范圍不包括：TheXYZsystemisvalidatedseparately.ＸＹＺ系統(tǒng)單獨(dú)驗(yàn)證TheDataHistorianisvalidatedseparately.數(shù)據(jù)歷史單獨(dú)驗(yàn)證<listallthatareappropriate>其他名單RelatedValidation相關(guān)驗(yàn)證<Insertadescriptionofanyexistingorplannedvalidationthatisrelevanttothevalidationofthissystem.Theuseofpriordatamaybeconsideredeitherasreferencefortestmethodsordirectlyreplacingtests,ifthesystemsconfigurationcanbeshowntobethesamenowasatthetimethedatawascollected>插入現(xiàn)有的或計(jì)劃的與本驗(yàn)證系統(tǒng)有關(guān)的驗(yàn)證的描述。如果系統(tǒng)配置和數(shù)據(jù)采集時(shí)是一致的，前期數(shù)據(jù)的使用可以作為試驗(yàn)方法的參考或直接替代試驗(yàn)，Therelatedvalidationthatwilloccurinsupportofthe<equipmentname>includesallthefollowingthatarenecessaryforthesystemtobeplacedintooperation.<clearlydefineallboundaries>支持（設(shè)備名稱）的相關(guān)驗(yàn)證在以下情況發(fā)生：包括系統(tǒng)運(yùn)行必需的幾點(diǎn)（清晰的定義分界線）：ProcessValidation工藝驗(yàn)證CleaningStudies清潔研究AirClassification風(fēng)力分級(jí)MicrobiologicalTesting微生物試驗(yàn)ChemicalTesting化學(xué)試驗(yàn)DryingStudies干燥研究SterilizationStudies無(wú)菌研究<listallthatareappropriate>其他名單Objectives目標(biāo)Theobjectiveofthisvalidationplanistooutlinetherequirementsthatwilldemonstrateanddocumentthatallcomponents,controlsystem(s)andfunctionalityassociatedwiththe<equipmentname>areappropriateforcGMP-regulatedprocesses.Thequalificationsoutlinedaretobebasedon<companyname>policiesandproceduresandapplicableregulations,guidelines,andacceptedindustrypracticesforvalidation.該項(xiàng)驗(yàn)證計(jì)劃的目標(biāo)是簡(jiǎn)述一項(xiàng)要求，該要求能夠證明所有與設(shè)備名稱相關(guān)的組成、控制系統(tǒng)和功能都是恰當(dāng)?shù)姆犀F(xiàn)行ＧＭＰ標(biāo)準(zhǔn)的工藝。資格的綜述要基于（公司名稱）政策，程序以及可應(yīng)用的規(guī)則、指導(dǎo)方針和公認(rèn)的工業(yè)驗(yàn)證實(shí)踐。PeriodicReview定期回顧ThisPlanshouldbereviewedperiodicallytoensurecomplianceandortodetermineifachangeisrequired.Someappropriatetimestorevieware:這份計(jì)劃應(yīng)該被定期回顧來(lái)保證符合并確定是否需要更改。一些適當(dāng)?shù)幕仡檿r(shí)間是：ChangeinValidationMasterPlan驗(yàn)證主文件的更改發(fā)生時(shí)Changeinscopeoccurs驗(yàn)證范圍的更改發(fā)生時(shí)Designchangeoccurs設(shè)計(jì)更改發(fā)生時(shí)PriortoIQandOQ在進(jìn)行ＩＱ和ＯＱ之前CompletionofIQandOQＩＱ和ＯＱ完成時(shí)Seesection5foradescriptionofValidationManagementandtheprocessforreviewandrevisionstothisplanorrefertotheapplicablecorporatepolicyreviewcycle.見(jiàn)第五部分有關(guān)驗(yàn)證管理和針對(duì)該項(xiàng)計(jì)劃的回顧、修訂過(guò)程或指適應(yīng)公司政策的回顧周期。2.OrganizationalStructure組織結(jié)構(gòu)Specificresponsibilitiesrelatedtothevalidationofthe<equipmentname>areoutlinedinAppendixA.Ingeneral,theactivitiesassociatedwiththisproject,aretheresponsibilityofthefollowingindividualsandgroups:與（設(shè)備名稱）驗(yàn)證相關(guān)的具體職責(zé)在附錄Ａ中概述。大體上，與驗(yàn)證相關(guān)的活動(dòng)項(xiàng)目由以下個(gè)人和部門負(fù)責(zé)：<Thedefinedroleandresponsibilitiesshouldincludeataminimumtheindividualslistedbelow-Describeeachroleandresponsibilityinageneralwayastheyapply>確定個(gè)人的任務(wù)和責(zé)任至少應(yīng)包括以下幾點(diǎn)，總體根據(jù)崗位不同描述每項(xiàng)任務(wù)和責(zé)任Managementlevel–Responsibleforprojectmanagementandplanning,controlofprojectactivities/resources/costs,monitoringprocess,initiatingcorrectiveaction,ensuringissues/projectobjectivesarecorrectlyaddressed/resolved,reportingtoseniormanagement,interfacetoQAtoensurecompliance,reviewingandapprovingvalidationdocumentationfortheproject…管理層：負(fù)責(zé)項(xiàng)目管理和計(jì)劃。方案，活動(dòng)，資源，成本的控制，監(jiān)控工藝，QualityAssurance–Responsibleforassuringcompliancewithappropriateregulatory/business/technical/usercommunityrequirements,providingsupportforthecriterion/independentreview/approvalofdeliverables,approvingcompletionofstage/validationstatus…質(zhì)保：負(fù)責(zé)保證符合適當(dāng)?shù)恼{(diào)整、商業(yè)、技術(shù)、用戶群要求，支持維護(hù)標(biāo)準(zhǔn)、獨(dú)立審查、可交付的批準(zhǔn)、審批完成階段和身份驗(yàn)證等。SystemOwner–Responsibleforimplementation/managementofthesystembythebusinessusercommunity,approvingcompletionofstage/validationstatus…系統(tǒng)所有者：負(fù)責(zé)執(zhí)行和管理系統(tǒng)的用戶群，審批完成階段和驗(yàn)證身份。<Theseroleandresponsibilitiesmaybedefinedasappropriate-Describeeachroleandresponsibilityinageneralwayastheyapply>這些任務(wù)和責(zé)任可以適當(dāng)?shù)亩x：按照他們的分工總體上定義每項(xiàng)任務(wù)和責(zé)任。Operations–Responsibleforproviding…操作：負(fù)責(zé)提供…ProjectLevel–Responsibleforproviding…項(xiàng)目水平：負(fù)責(zé)提供…TechnicalandEngineeringsupport–Responsibleforproviding…技術(shù)和工程支持：負(fù)責(zé)提供…ValidationSpecialist–Responsibleforproviding…驗(yàn)證專家：負(fù)責(zé)提供…SystemAdministrator–Responsibleforproviding…系統(tǒng)管理：負(fù)責(zé)提供…Purchasing-Responsibleforproviding…采供：負(fù)責(zé)提供…<Listallthatareappropriate>其他名單3.GxPCriticalityAssessmentGxP關(guān)鍵性估計(jì)DetailtheGxPcriticalityassessmentinformationrelatedtothe<equipmentname>.Thissectionmayreferenceanothersourceofinformationcoveringthistopic,suchasasysteminventory.詳述和（設(shè)備名稱）有關(guān)的GxP關(guān)鍵性估計(jì)信息。該部分包括另外一種信息，包括該主題，例如系統(tǒng)詳細(xì)目錄。3.1GxPCriticalityAssessment–RequirementsGxP關(guān)鍵性評(píng)估——要求DefinetherequirementsusedinthedeterminationofthelevelsforGxPcriticalityforthe<equipmentname>.TherequirementsfordeterminationofthelevelsforGxPcriticalitymayincludeDirectImpact,IndirectImpact,andNoImpactsystems.定義在決定（設(shè)備名稱）Gxp水平中使用的關(guān)鍵性要求，包括直接影響，間接影響和無(wú)影響系統(tǒng)。DirectImpact–Systemorcomponentwithinasystemwheretheoperation,contact,data,control,alarm,orfailurewillhaveadirectimpactonproductquality.直接影響：系統(tǒng)或系統(tǒng)中的一個(gè)組成，對(duì)產(chǎn)品質(zhì)量有直接影響的操作，接觸，控制，預(yù)警或失敗。IndirectImpact–Systemorcomponentwithinasystemwheretheoperation,contact,data,control,alarm,orfailurewillnothaveadirectimpactonproductquality.IndirectImpactsystemstypicallysupportDirectImpactsystems,thusindirectimpactsystemmayhaveanaffectontheperformanceoroperationofadirectimpactsystem.間接影響：系統(tǒng)或系統(tǒng)中的一個(gè)組成，對(duì)產(chǎn)品質(zhì)量無(wú)直接影響的操作，接觸，控制，預(yù)警或失敗。間接影響系統(tǒng)專門支持直接影響系統(tǒng)，因此間接影響系統(tǒng)會(huì)對(duì)直接影響系統(tǒng)的執(zhí)行和運(yùn)作構(gòu)成影響。NoImpact–Systemorcomponentwithinasystemwheretheoperation,contact,data,control,alarm,orfailurewillnothaveadirectorindirectimpactonproductquality.NoImpactsystemswillnotsupportDirectImpactsystems.無(wú)影響：系統(tǒng)或系統(tǒng)的一個(gè)組成，對(duì)產(chǎn)品質(zhì)量不構(gòu)成直接或間接影響的操作，接觸，控制，預(yù)警或失敗。無(wú)影響系統(tǒng)不能支持直接影響系統(tǒng)。3.2GxPCriticalityAssessment–ProceduresGxP關(guān)鍵性評(píng)估-程序Definetheproceduresused/followedintheassessmentofthelevelsforGxPcriticalityforthe<equipmentname>.DevelopadocumentedpaththatwillbefollowedtodeterminethelevelsforGxPcriticalityforeachitemassociatedwiththe<equipmentname>.ItmaybehelpfultodevelopadecisiontreetodemonstratetheoverviewtotheprocessrequiredindetermininglevelsforGxPcriticality.Internalproceduresmaybereferenced,ifavailable.定義使用的程序/（設(shè)備名稱）的Gxp關(guān)鍵性水平的評(píng)估的標(biāo)準(zhǔn)。開(kāi)發(fā)一種具有證明的文件路徑，作為（設(shè)備名稱）GxP關(guān)鍵性水平每一項(xiàng)目的評(píng)估標(biāo)準(zhǔn)。創(chuàng)建一個(gè)決策樹(shù)將對(duì)在GxP關(guān)鍵性評(píng)估中論證工藝的一般觀察要求有幫助。如果必要，可以引用國(guó)際程序作為參考。3.3GxPCriticalityAssessment–CurrentStatusGxP關(guān)鍵性評(píng)估-現(xiàn)行標(biāo)準(zhǔn)StatethecurrentstatusoftheassessmentfortheGxPcriticalitylevelsforthe<equipmentname>.陳述現(xiàn)行（設(shè)備名稱）的GxP關(guān)鍵性水平評(píng)估的要求。TheDirectImpactSystemsassociatedwiththe<equipmentname>includeallthefollowing.<Clearlydevelopsupportingrationale>（設(shè)備名稱的）直接影響因素包括以下的所有項(xiàng)。（清楚的規(guī)定支持理論）Controlssystemhardwareandsoftware-Thishasbeendeemedadirectimpactsystemdueto…控制系統(tǒng)硬件和軟件：該項(xiàng)是一個(gè)直接影響由于…MechanicalHardware-Thishasbeendeemedadirectimpactsystemdueto…機(jī)械硬件：該項(xiàng)是一個(gè)直接影響由于…Instrumentation–Thishasbeendeemedadirectimpactsystemdueto…儀器：該項(xiàng)是一個(gè)直接影響由于…Processpiping-Thishasbeendeemedadirectimpactsystemdueto…工藝流程：該項(xiàng)是一個(gè)直接影響由于…UtilitySystems-Thishasbeendeemedadirectimpactsystemdueto…效用系統(tǒng)：該項(xiàng)是一個(gè)直接影響由于…Facility-Thishasbeendeemedadirectimpactsystemdueto…設(shè)備：該項(xiàng)是一個(gè)直接影響由于…<Listallthatareappropriate>其他名單TheIndirectImpactSystemsassociatedwiththe<equipmentname>includeallthefollowing.<Clearlydevelopsupportingrationale>（設(shè)備名稱的）間接影響因素包括以下的所有項(xiàng)。（清楚的規(guī)定支持原理）Controlssystemhardwareandsoftware-Thishasbeendeemedanindirectimpactsystemdueto…控制系統(tǒng)硬件和軟件：該項(xiàng)是一個(gè)間接影響由于…MechanicalHardware-Thishasbeendeemedanindirectimpactsystemdueto…機(jī)械硬件：該項(xiàng)是一個(gè)間接影響由于…Instrumentation–Thishasbeendeemedanindirectimpactsystemdueto…儀器：該項(xiàng)是一個(gè)間接影響由于…Processpiping-Thishasbeendeemedanindirectimpactsystemdueto…工藝流程：該項(xiàng)是一個(gè)間接影響由于…UtilitySystems-Thishasbeendeemedanindirectimpactsystemdueto…效用系統(tǒng)：該項(xiàng)是一個(gè)間接影響由于…Facility-Thishasbeendeemedanindirectimpactsystemdueto…設(shè)備：該項(xiàng)是一個(gè)間接影響由于…<Listallthatareappropriate>其他名單TheNoImpactSystemsassociatedwiththe<equipmentname>includeallthefollowing.<Clearlydevelopsupportingrationale>（設(shè)備名稱的）無(wú)影響因素包括以下的所有項(xiàng)。（清楚的規(guī)定支持原理）Controlssystemhardwareandsoftware-Thishasbeendeemedanoimpactsystemdueto…控制系統(tǒng)硬件和軟件：該項(xiàng)是一個(gè)無(wú)影響系統(tǒng)由于…MechanicalHardware-Thishasbeendeemedanoimpactsystemdueto…機(jī)械硬件：該項(xiàng)是一個(gè)無(wú)影響系統(tǒng)由于…Instrumentation–Thishasbeendeemedanoimpactsystemdueto…儀器：該項(xiàng)是一個(gè)無(wú)影響系統(tǒng)由于…UtilitySystems-Thishasbeendeemedanoimpactsystemdueto…工藝流程：該項(xiàng)是一個(gè)無(wú)影響系統(tǒng)由于…Facility-Thishasbeendeemedanoimpactsystemdueto…設(shè)備：該項(xiàng)是一個(gè)無(wú)影響系統(tǒng)由于…<Listallthatareappropriate>其他名單4.ValidationStrategy驗(yàn)證策略4.1LifeCycle生命周期Definetheinternalrequirementsfordevelopment,testing,delivery,andsupportthatdefinetheperiodoftimethatbeginswhenasystemisconceivedandendswhenthesystemisnolongeravailableforuse.陳述國(guó)內(nèi)研發(fā)，測(cè)試，運(yùn)輸和維護(hù)的要求，定義驗(yàn)證開(kāi)始的時(shí)間段（系統(tǒng)存在時(shí)開(kāi)始），系統(tǒng)結(jié)束的時(shí)間（系統(tǒng)不可用時(shí)結(jié)束）。4.2RiskAssessment風(fēng)險(xiǎn)評(píng)估StatethecurrentstatusoftheassessmentfortheGxPRiskandBusinessRiskforthe<equipmentname>.Theprocessneedstoaddressthefollowingquestions:陳述現(xiàn)行（設(shè)備名稱）的GxP關(guān)鍵性水平評(píng)估的風(fēng)險(xiǎn)和商業(yè)風(fēng)險(xiǎn)。該程序必須包括以下問(wèn)題：Doesthisautomatedsystemrequirevalidation?自動(dòng)化系統(tǒng)需要驗(yàn)證嗎？Howmuchvalidationisrequiredforthissystem?該系統(tǒng)要求多少驗(yàn)證？Whataspectsofthesystemorprocessarecriticaltoproductandpatientsafety?系統(tǒng)的哪個(gè)方面或工藝對(duì)產(chǎn)品和患者安全性是關(guān)鍵性因素？Whataspectsofthesystemorprocessarecriticaltobusiness?系統(tǒng)的哪個(gè)方面或工藝過(guò)程對(duì)商業(yè)是關(guān)鍵性因素?4.3HardwareCategories硬件分類Definethecategoriesofthehardwareassociatedwiththe<equipmentname>.定義(設(shè)備名稱)的硬件種類HardwarecomponentsofasystemcanbeanalyzedandcategorizedintooneofthefollowingGAMPdefinedcategories:硬件系統(tǒng)組成可以按照以下GAMP詳述的分類方法進(jìn)行分析和歸類：HardwareCategory1–StandardHardwareComponents硬件分類1:標(biāo)準(zhǔn)硬件組成HardwareCategory2–CustomBuiltHardwareComponents硬件分類2：定制的硬件組成4.4SoftwareCategories軟件分類Definethecategoriesofthesoftwareassociatedwiththe<equipmentname>.定義(設(shè)備名稱)的軟件種類SoftwarecomponentsofasystemcanbeanalyzedandcategorizedintooneofthefollowingGAMPdefinedcategories:軟件系統(tǒng)組成可以按照以下GAMP詳述的分類方法進(jìn)行分析和歸類：SoftwareCategory1–OperatingSystems軟件分類1：運(yùn)行系統(tǒng)SoftwareCategory2–Firmware軟件分類2：固件（軟件硬件相結(jié)合）SoftwareCategory3–StandardSoftwarePackages軟件分類3：標(biāo)準(zhǔn)軟件包SoftwareCategory4–ConfigurableSoftwarePackages軟件分類4：結(jié)構(gòu)軟件包SoftwareCategory5–CustomSoftware軟件分類5：定制軟件4.5ProjectInputs/OutputsforStages項(xiàng)目各階段的輸入/輸出Definetheprojectinputandoutputsforeachstageoftheprojectassociatedwiththe<equipmentname>.詳述（設(shè)備名稱）的相關(guān)項(xiàng)目每一階段的的輸入/輸出4.6AcceptanceCriteriaforStages各階段的接受標(biāo)準(zhǔn)Definetheacceptancecriteriaforeachstageoftheprojectassociatedwiththe<equipmentname>.詳述（設(shè)備名稱）的相關(guān)項(xiàng)目各階段的接受標(biāo)準(zhǔn)。5.ValidationDeliverables驗(yàn)證可交付性ThebalanceofthisPlanoutlinesspecificvalidationactivitiesandproductsthatwillbecreatedandassembledthroughoutthesystemdevelopmentlifecycleandcollectivelywillcomprisetheValidationPackage.ThePlancanserveasanoverviewor"roadmap"totheindividualvalidationproductsasspecifiedbythe<applicablecorporatepolicy>.Additionaldetail,includingimplementationinformation,canbefoundintheindividualproductsthemselves.該計(jì)劃的平衡略述產(chǎn)生和聚集于系統(tǒng)開(kāi)發(fā)的整個(gè)生命過(guò)程中的具體的驗(yàn)證活動(dòng)和產(chǎn)品，包含驗(yàn)證包。該計(jì)劃可以作為對(duì)公司適用政策中規(guī)定的個(gè)別驗(yàn)證產(chǎn)品的一個(gè)回顧或路線圖。補(bǔ)充細(xì)節(jié)，包括執(zhí)行信息，可以在個(gè)別產(chǎn)品中找到。

5.1TraceabilityandLinkages描述和鏈接ThisdocumentlinkstheURS,FRS,DesignSpecificationsandtheTestingSpecifications(IQ,OQ,PQ)pertheV-Model這份文件像下面所示的V模型一樣與URS,FRS,設(shè)計(jì)闡述和檢測(cè)說(shuō)明(IQ,OQ,PQ)鏈接UserRequirementsSpecificationUserRequirementsSpecification使用要求PerformanceQualificationVerifies證實(shí)Verifies證實(shí)使用者的需求說(shuō)明執(zhí)行條件OperationalQualificationFunctionalOperationalQualificationFunctionalSpecificationsVerifies證實(shí)Verifies證實(shí)功能闡述運(yùn)作條件InstallationQualificationDesignSpecificationsInstallationQualificationDesignSpecificationsVerifies證實(shí)Verifies證實(shí)設(shè)計(jì)闡述設(shè)立條件BuildSystemBuildSystem構(gòu)筑體系5.2MasterListofallValidationProductsandSupportingDocumentation所有批準(zhǔn)產(chǎn)品和證明文件的總清單5.3UserRequirementsSpecification(URS)使用說(shuō)明書Thisdocumentdescribeswhattheequipmentisintendedtodoandallessentialrequirementssuchasproductionrates,operatingranges,etc.Itisusuallydevelopedbytheowner.ThisdocumentlinkstothePQdocumentwhichtestsforeachoftherequirements.此文件描述了儀器的用途，和對(duì)使用率，操作范圍等的主要要求，通常是儀器的持有者對(duì)其進(jìn)行改進(jìn)，此文件與對(duì)各項(xiàng)要求進(jìn)行測(cè)試的PQ文件相結(jié)合。5.4FunctionalRequirementSpecification(FRS)功能說(shuō)明書Thisdocumentdescribesthedetailedfunctionalityoftheequipment.Itisusuallydevelopedbythesupplier.ThisdocumentislinkedtotheOQdocumentwhichtestsforeachfunction.次文件對(duì)儀器詳細(xì)功能進(jìn)行的了描繪，通常是儀器供應(yīng)商對(duì)其進(jìn)行改進(jìn)，此文件與檢測(cè)各項(xiàng)功能的OQ文件相結(jié)合。5.5ConfigurationManagementandChangeControlDocumentation配置管理和變速控制文件Changecontrolisaformalprocessbywhichqualifiedrepresentativesofappropriatedisciplinesreviewproposedoractualchangesthatmightaffectavalidatedand/orapprovedstatus.Theintentistodeterminetheneedforactionthatwouldensureanddocumentthatthesystemmaintainsthisstatus.Thisprocessdocumentsthepre-implementationchangesandpost-implementationchanges.DocumentsthatrequirechangecontrolmayincludeanyoftheValidationProductslistedinsection5.變化控制是正式的程序，是根據(jù)適當(dāng)?shù)闹貜?fù)檢測(cè)而得出的有代表性的檢測(cè)而提出的。其目的是決定操作規(guī)程和保持系統(tǒng)穩(wěn)定的文件。這個(gè)程序?yàn)樽兯偾昂蟮陌惭b啟用提供證明。要求執(zhí)行變速控制的文件應(yīng)該包括第5部分目錄中任何一個(gè)合格產(chǎn)品。5.6VendorQualificationdocumentation賣主資格認(rèn)證Providedocumentationthatverifiesthatvendor(s)arequalified,competentandexperienced.提供文件來(lái)證實(shí)賣主是有資格的，有能力的，有經(jīng)驗(yàn)的5.7DesignSpecifications設(shè)計(jì)說(shuō)明Includeanydocumentsrequiredtosupportinstallation.(Thefollowingdocumentsareexamples,butarenotmeanttobeanexclusivelist).包括所有需要支持安裝裝置的文件。（以下文件供參考，但不是完整清單）Detailedprocessdescriptions,narratives,andsequenceofoperations詳細(xì)的工藝種類，描述和操作性的Subsystemdefinitions子系統(tǒng)得定義DataFlowDiagrams流程表數(shù)據(jù)ProcessFlowDiagrams工藝流程數(shù)據(jù)Systemarchitecturedra系統(tǒng)建筑學(xué)數(shù)據(jù)Pipingandinstrumentationdiagrams管道和儀器圖表Controlwiringdiagrams控制配線圖表Powerdistributionandgroundingdiagrams分銷能力和基地表Panellayoutdrawings設(shè)計(jì)圖紙Hardwareandsoftwaredesignspecifications硬件和軟件設(shè)計(jì)說(shuō)明書B(niǎo)illofmaterials物料清單Otherdocumentsrequiredforinstallation,operationsandmaintenance其他安裝，運(yùn)行和維護(hù)文件5.7.1TraceabilityMatrix矩陣描述Thetraceabilityofcriticalparametersanddatathroughthedesignprocesstothefinaltestingstagewillbemaintainedusingamatrix.Thismatrixshalldetailallcriticalequipmentandsoftwareparametersandlinkthemtotheirindividualtestcasesandthedocumentinwhichtheyappear.Therequirementstraceabilitymatrixshallbemaintainedunderchangecontrolforthelifeoftheequipment.從設(shè)計(jì)階段到最終的測(cè)試階段的重要參數(shù)和數(shù)據(jù)的描述應(yīng)該用矩陣來(lái)表示。這個(gè)矩陣應(yīng)該詳述所有的關(guān)鍵設(shè)備和軟件的參數(shù)，并鏈接到他們各自所在的檢測(cè)文件中。需求量的描述應(yīng)該維持在設(shè)備壽命變化控制以下。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