浅谈计算机设备验证课件

设备验证2008年11月2023/12/51Validation验证“Establishingdocumentedevidencewhichprovidesahighdegreeofassurancethataspecificprocesswillconsistentlyproduceaproductmeetingitspredeterminedspecificationsandqualityattributes”. 建立一个文件化的证据,以提供一个高水准的保证体系,确保生产出的产品始终符合预定的标准和质量要求。

FDAGuidelinesonGeneralPrinciplesofProcessValidation,May1987.Documents文件2023/12/52Operational运行确认QualificationInstallation安装确认QualificationDesignQualification设计确认Sequenceofdocuments文件建立次序SpecificationQualification标准确认-URS用户需求

-SpecificationsSystem设计基础文件设计&安装-Mechanical机械Airunit空调Electrical电设计&安装Hardware硬件Software软件IQ安装确认-ACSHardware硬件Software软件IQ安装确认-Mechanical机械Airunit空调Electrical电OQ运行确认-ACSHardware硬件Software软件OQ运行确认-Mechanical机械Airunit空调Electrical电PerformanceQualification性能确认-SystemSystemOwner系统使用者EngineeringC.工程部ACSC计算机工程师.Mech.C.机械工程师ACSC./SystemOwner计算机工程师/系统使用者MechanicalC./SystemOwner机械工程师/系统使用者SystemOwner系统使用者2023/12/53VModelLifeCycle2023/12/54URS-systemlevel用户需求Specifications标准URS用户需求projectlevel项目层面参数一览表Systemlist系统清单Blockdiagram设计结构图纸概括的系统描述PFD流程图Criticalityanalysis重要项分析MasterValidationPlan验证主计划Traceabilitymatrix矩阵图Goodfordesign用于设计2023/12/55Design-Basicdocuments基础设计文件Detailedsystemdescription详细系统描述PIDGeneralsystemdescription概括的系统描述PFD流程图Roomdatasheets–Parameters参数一览表Traceabilitymatrix矩阵图Instrumentlist仪表清单Equipmentlist设备清单Parameterlist参数清单Alarmlist报警项目清单Goodforconstruction用于制造Traceabilitymatrix矩阵图2023/12/56Design&Installation-ACS/Software

设计及安装－软件Detailedsystemdescription详细系统描述Parameterlist参数清单Alarmlist报警项目清单PIDInstrumentlist仪表清单Equipmentlist设备清单Traceabilitymatrix矩阵图Softwaredesignconcept软件概念设计Testplan测试计划TestdocumentsFAT设备生产厂测试文件Programreviewreport回顾报告Applicationsoftware应用软件ReadyforFATTraceabilitymatrix矩阵图2023/12/57ReadyforFAT进入设备生产厂测试阶段Design&Installation-ACS/Hardware

设计及安装－硬件Detailedsystemdescription详细的系统描述Parameterlist参数清单Alarmlist报警清单PIDInstrumentlist仪表清单Equipmentlist设备清单Traceabilitymatrix矩阵图Hardwaredesignconcept硬件概念设计I/OlistI/O清单Addresslist地址清单DatasheetsInstruments仪表一览表PLCconfigurationPLC配置Electricaldrawings电气图Controlpanels控制面板Instruments仪表Traceabilitymatrix矩阵图2023/12/58Design&Installation–Mechanical

设计&安装－机械部分Detailedsystemdescription详细的系统描述Parameterlist参数清单Alarmlist报警清单PIDInstrumentlist仪表清单Equipmentlist设备清单Traceabilitymatrix矩阵图Powerdistribution电路分配Airducting空调管路Piping管道Airductinglayout空调管路图Electricallayout电气图Equipmentlayout设备图Pipinglayout管道图DatasheetsEquipment设备一览表Equipment设备ReadyforSAT进入SATReadyforFAT进入FAT2023/12/59Testing-FATsoftware

测试－FAT软件部分Traceabilitymatrix矩阵图Applicationsoftware应用软件FAT测试文件FATprocedures程序FATprotocols方‘案FactoryAcceptanceTest设备生产厂测试SoftwareFATreport软件部分测试报告Software软件2023/12/510Testing-FAThardware

测试－FAT硬件部分Traceabilitymatrix矩阵图Electricalpanels仪表板TestdocumentsFAT测试文件FATprocedures程序FATprotocols方案FactoryAcceptanceTest设备生产厂测试hardwareFATreport硬件的FAT报告Hardware硬件Instruments仪表Calibrationcertificates校验证书2023/12/511Testing-FATEquipment

测试－FAT设备部分Traceabilitymatrix矩阵图Equipment设备TestdocumentsFAT测试文件FATprocedures程序FATprotocols方案FactoryAcceptanceTest设备生产厂测试EquipmentFATreport设备的FAT报告Equipment设备Certificates合格证书2023/12/512Fieldinstallationverification

现场安装确认Traceabilitymatrix矩阵图Systeminstallation系统安装Designdocuments设计文件IOtestprotocolIO测试方案Tightnesstestprotocols严密的测试方案FieldinstallationverificationReport现场安装确认报告System系统FieldInstallationVerification现场安装确认2023/12/513Approval1

批准SoftwareFATreport软件的FAT报告HardwareFATreport硬件的FAT报告EquipmentFATreport设备FAT报告Fieldinstallationverificationreport现场安装报告Approved批准ReadyforSAT进入SAT2023/12/514Testing-SATsoftware

测试－SAT软件Traceabilitymatrix矩阵图Applicationsoftware应用软件TestdocumentsSATSAT测试文件SATprocedures程序SATprotocols方案SiteAcceptanceTest工厂测试SoftwareSATreport软件SAT报告Software软件2023/12/515Testing-SATequipment

测试－SAT设备部分Traceabilitymatrix矩阵图Equipment设备TestdocumentsSATSAT测试文件SATprocedures程序SATprotocols方案SiteAcceptanceTest工厂测试EquipmentSATreport设备SAT报告Equipment设备Certificates合格证书2023/12/516Approval2SoftwareSATreport软件SAT报告EquipmentSATreport设备SAT报告ReadyforPerformancetesting进入性能测试Approved

批准2023/12/517Systems1System=1PIDExample如: 1airhandlingunit一个空调单元 1cleansteamgenerator一个清洁蒸汽发生器 3holdingtanks三个储罐Asystemisacompositionofcomponentsthatlogicallycohereinordertofulfilaparticularfunctionality一个系统是由多个单元组成的复合体，各单元组合在一起而完成特定的功能2023/12/518Traceability

追溯性Projectdocumentsmustbetraceabletorequirements项目文件必须有追溯性

DesigndocumentsmustbetraceabletoURS设计文件对应于URSTestingmustbetraceabletodesignspecificationandURS测试对应于设计标准和URSURSprojectlevelURS项目层面URSsystemlevelURS系统层面DesignDocuments设计文件Tests测试Useofatraceabilitymatrixistherecommendedmethod推荐用追溯性的矩阵图2023/12/519Criticality

关键CriticalityAnalysisisessentialtogoodproject重要性分析是一个好项目成功的关键intendedtofocuseffortonmostcriticalareasfor