翻譯后的計算機化系統(tǒng)驗證模板

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

Author'sSignature:授權者簽名Yoursignatureindicatesthatthisdocumenthasbeenpreparedinaccordancewithexistingprojectstandardsandadequatelyreflectsthetasksanddeliverablesnecessaryforvalidationofthe<equipmentname>您的簽名表明這份文件的準備符合現(xiàn)行項目標準并且充分反映人物u和可交付使用對<設備名稱>驗證的必要。AuthoredBy:經(jīng)授權：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，確認它精確并完全的反映任務和可交付使用對<設備名稱>驗證的必要。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:質檢/承認簽名Yoursignatureindicatesthatthisdocumentcomplieswith<referenceValidationMasterPlan,companystandardsorguidelines>;andthatthedocumentationandinformationcontainedhereincomplieswithapplicableregulatory,corporate,divisional/departmentalrequirements,andcurrentGoodManufacturingPractices.您的簽名表明這份文件符合〈證明人驗證總計劃，企業(yè)標準或政策〉，并且在此包含的文件和信息符合可應用的可調整的，共同的以及部門所有的／部門的要求和現(xiàn)行的ＧＭＰ標準。ApprovedBy:經(jīng)核準：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.更新封頁面的JETT的標識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驗證范圍 51.4 Objectives目標 61.5 PeriodicReview定期審查 62. OrganizationalStructure組織結構 73. GxPCriticalityAssessmentGxP關鍵性評估 73.1 GxPCriticalityAssessment-RequirementsGxP關鍵性評估——要求 73.2 GxPCriticalityAssessment-ProceduresGxP關鍵性評估——程序83.3 GxPCriticalityAssessment–CurrentStatusGxP關鍵性評估——現(xiàn)行標準 84. ValidationStrategy驗證策略 94.1 LifeCycle生命周期 94.2 RiskAssessment風險評估 94.3 HardwareCategories硬件分類 94.4 SoftwareCategories軟件分類 94.5 ProjectInputs/OutputsforStages項目各階段的輸入/輸出 104.6 AcceptanceCriteriaforStages各階段的接受標 105. ValidationDeliverables 105.1 TraceabilityandLinkages描述和鏈接115.2 MasterListofallValidationProductsandSupportingDocumentation所有批準產品和證明文件的總清單115.3 UserRequirementsSpecification(URS)使用說明書 115.4 FunctionalRequirementSpecification(FRS)功能說明書 115.5 ConfigurationManagementandChangeControlDocumentation配置管理和變速控制文件115.6 VendorQualificationdocumentation賣主資格認證115.7 DesignSpecifications設計說明 125.8 TestingandVerificationRequirementsDocumentation試驗和確認所需文件 125.9 SystemSecurity系統(tǒng)安全性 135.10 OperationalSupport運行支持 145.11 BusinessContinuityPlan業(yè)務持續(xù)計劃 145.12 DisasterRecovery,BackupandRestoration災難性恢復，備份及修復 145.13 SystemAcceptance–FinalReport系統(tǒng)接受――終報告 145.14 <Listanyadditionalvalidationproductsrequired>列出任何其他需要驗證的產品 156. AcceptanceCriteria可接受標準 157. ChangeControl變更控制 157.1 Pre-ImplementationChanges預執(zhí)行變更 157.2 Post-ImplementationChanges執(zhí)行后變更 158. StandardOperatingProceduresSOP 158.1 SOPResponsibilitiesSOP職責 158.2 ListingofSOPsSOP列表 169. Training培訓 1610. DocumentationManagement資料管理 1610.1 DocumentProduction文件產生 1610.2 DocumentReview文件回顧 1610.3 DocumentApproval文件批準 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驗證狀態(tài)的維護 1711.1 SystemRetirement系統(tǒng)引退 1712. ValidationActivitiesTimeline驗證執(zhí)行時間表 17AppendixA附錄A參與組織 18AppendixB附錄B縮寫詞，定義 19AppendixC附錄C責任/時間 22AppendixD附錄D可交付的驗證 23AppendixE附錄E參考 24(ReminderofPageIntentionallyLeftBlank)

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

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,設計闡述和檢測說明(IQ,OQ,PQ)鏈接UserRequirementsSpecificationUserRequirementsSpecification使用要求PerformanceQualificationVerifies證實Verifies證實使用者的需求說明執(zhí)行條件OperationalQualificationFunctionalOperationalQualificationFunctionalSpecificationsVerifies證實Verifies證實功能闡述運作條件InstallationQualificationDesignSpecificationsInstallationQualificationDesignSpecificationsVerifies證實Verifies證實設計闡述設立條件BuildSystemBuildSystem構筑體系5.2MasterListofallValidationProductsandSupportingDocumentation所有批準產品和證明文件的總清單5.3UserRequirementsSpecification(URS)使用說明書Thisdocumentdescribeswhattheequipmentisintendedtodoandallessentialrequirementssuchasproductionrates,operatingranges,etc.Itisusuallydevelopedbytheowner.ThisdocumentlinkstothePQdocumentwhichtestsforeachoftherequirements.此文件描述了儀器的用途，和對使用率，操作范圍等的主要要求，通常是儀器的持有者對其進行改進，此文件與對各項要求進行測試的PQ文件相結合。5.4FunctionalRequirementSpecification(FRS)功能說明書Thisdocumentdescribesthedetailedfunctionalityoftheequipment.Itisusuallydevelopedbythesupplier.ThisdocumentislinkedtotheOQdocumentwhichtestsforeachfunction.次文件對儀器詳細功能進行的了描繪，通常是儀器供應商對其進行改進，此文件與檢測各項功能的OQ文件相結合。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?shù)闹貜蜋z測而得出的有代表性的檢測而提出的。其目的是決定操作規(guī)程和保持系統(tǒng)穩(wěn)定的文件。這個程序為變速前后的安裝啟用提供證明。要求執(zhí)行變速控制的文件應該包括第5部分目錄中任何一個合格產品。5.6VendorQualificationdocumentation賣主資格認證Providedocumentationthatverifiesthatvendor(s)arequalified,competentandexperienced.提供文件來證實賣主是有資格的，有能力的，有經(jīng)驗的5.7DesignSpecifications設計說明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設計圖紙Hardwareandsoftwaredesignspecifications硬件和軟件設計說明書Billofmaterials物料清單Otherdocumentsrequiredforinstallation,operationsandmaintenance其他安裝，運行和維護文件5.7.1TraceabilityMatrix矩陣描述Thetraceabilityofcriticalparametersanddatathroughthedesignprocesstothefinaltestingstagewillbemaintainedusingamatrix.Thismatrixshalldetailallcriticalequipmentandsoftwareparametersandlinkthemtotheirindividualtestcasesandthedocumentinwhichtheyappear.Therequirementstraceabilitymatrixshallbemaintainedunderchangecontrolforthelifeoftheequipment.從設計階段到最終的測試階段的重要參數(shù)和數(shù)據(jù)的描述應該用矩陣來表示。這個矩陣應該詳述所有的關鍵設備和軟件的參數(shù)，并鏈接到他們各自所在的檢測文件中。需求量的描述應該維持在設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