JETT 设备验证(中英文)

CompanyLogoDOCUMENTNUMBER:###-##PAGE:1of34LOCATION:Revision:Rev##EFFECTIVE:yyyy.mm.ddTITLE:VALIDATIONPLANFORTHEEquipmentName,ID#12345FileName:1583685981672LastSaveDate:08-Mar-2020PrintDate:3/8/20CompanyLogoDOCUMENTNUMBER:###-##PAGE:2of34LOCATION:Revision:Rev##EFFECTIVE:yyyy.mm.ddTITLE:VALIDATIONPLANFORTHEEquipmentName,ID#12345FileName:1583685981672LastSaveDate:08-Mar-2020PrintDate:3/8/20Author'sSignature:授权者签名Yoursignatureindicatesthatthisdocumenthasbeenpreparedinaccordancewithexistingprojectstandardsandadequatelyreflectsthetasksanddeliverablesnecessaryforvalidationoftheequipmentname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,youhavereviewedthisdocumentandthatitaccuratelyandcompletelyreflectsthetasksanddeliverablesnecessaryforvalidationoftheequipmentname.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YoursignatureindicatesthatthisdocumentcomplieswithreferenceValidationMasterPlan,companystandardsorguidelines;andthatthedocumentationandinformationcontainedhereincomplieswithapplicableregulatory,corporate,divisional/departmentalrequirements,andcurrentGoodManufacturingPractices.CompanyLogoDOCUMENTNUMBER:###-##PAGE:3of34LOCATION:Revision:Rev##EFFECTIVE:yyyy.mm.ddTITLE:VALIDATIONPLANFORTHEEquipmentName,ID#12345FileName:1583685981672LastSaveDate:08-Mar-2020PrintDate:3/8/20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CompanyLogoDOCUMENTNUMBER:###-##PAGE:4of34LOCATION:Revision:Rev##EFFECTIVE:yyyy.mm.ddTITLE:VALIDATIONPLANFORTHEEquipmentName,ID#12345FileName:1583685981672LastSaveDate:08-Mar-2020PrintDate:3/8/20RevisionHistory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1.Introduction绪论...................................................................................................................181.1Purpose目的...................................................................................................................181.2PolicyCompliance适用的政策.....................................................................................181.3ScopeofValidation验证范围.......................................................................................181.4Objectives目标...............................................................................................................181.5PeriodicReview定期审查.............................................................................................182.OrganizationalStructure组织结构........................................................................................183.GxPCriticalityAssessmentGxP关键性评估........................................................................183.1GxPCriticalityAssessment-RequirementsGxP关键性评估——要求.......................183.2GxPCriticalityAssessment-ProceduresGxP关键性评估——程序183.3GxPCriticalityAssessment–CurrentStatusGxP关键性评估——现行标准..............184.ValidationStrategy验证策略................................................................................................184.1LifeCycle生命周期.......................................................................................................184.2RiskAssessment风险评估.............................................................................................184.3HardwareCategories硬件分类......................................................................................184.4SoftwareCategories软件分类.......................................................................................184.5ProjectInputs/OutputsforStages项目各阶段的输入/输出.........................................184.6AcceptanceCriteriaforStages各阶段的接受标185.ValidationDeliverables..........................................................................................................185.1TraceabilityandLinkages描述和链接18CompanyLogoDOCUMENTNUMBER:###-##PAGE:5of34LOCATION:Revision:Rev##EFFECTIVE:yyyy.mm.ddTITLE:VALIDATIONPLANFORTHEEquipmentName,ID#12345FileName:1583685981672LastSaveDate:08-Mar-2020PrintDate:3/8/205.2MasterListofallValidationProductsandSupportingDocumentation所有批准产品和证明文件的总清单185.3UserRequirementsSpecification(URS)使用说明书.....................................................185.4FunctionalRequirementSpecification(FRS)功能说明书..............................................185.5ConfigurationManagementandChangeControlDocumentation配置管理和变速控制文件185.6VendorQualificationdocumentation卖主资格认证185.7DesignSpecifications设计说明...............................................................