淺談計(jì)算機(jī)設(shè)備驗(yàn)證課件

設(shè)備驗(yàn)證2008年11月2022/12/11設(shè)備驗(yàn)證2008年11月2022/12/11Validation驗(yàn)證“Establishingdocumentedevidencewhichprovidesahighdegreeofassurancethataspecificprocesswillconsistentlyproduceaproductmeetingitspredeterminedspecificationsandqualityattributes”. 建立一個文件化的證據(jù),以提供一個高水準(zhǔn)的保證體系,確保生產(chǎn)出的產(chǎn)品始終符合預(yù)定的標(biāo)準(zhǔn)和質(zhì)量要求。

FDAGuidelinesonGeneralPrinciplesofProcessValidation,May1987.Documents文件2022/12/12Validation驗(yàn)證“EstablishingdocuOperational運(yùn)行確認(rèn)QualificationInstallation安裝確認(rèn)QualificationDesignQualification設(shè)計(jì)確認(rèn)Sequenceofdocuments文件建立次序SpecificationQualification標(biāo)準(zhǔn)確認(rèn)-URS用戶需求

-SpecificationsSystem設(shè)計(jì)基礎(chǔ)文件設(shè)計(jì)&安裝-Mechanical機(jī)械A(chǔ)irunit空調(diào)Electrical電設(shè)計(jì)&安裝Hardware硬件Software軟件IQ安裝確認(rèn)-ACSHardware硬件Software軟件IQ安裝確認(rèn)-Mechanical機(jī)械A(chǔ)irunit空調(diào)Electrical電OQ運(yùn)行確認(rèn)-ACSHardware硬件Software軟件OQ運(yùn)行確認(rèn)-Mechanical機(jī)械A(chǔ)irunit空調(diào)Electrical電PerformanceQualification性能確認(rèn)-SystemSystemOwner系統(tǒng)使用者EngineeringC.工程部ACSC計(jì)算機(jī)工程師.Mech.C.機(jī)械工程師ACSC./SystemOwner計(jì)算機(jī)工程師/系統(tǒng)使用者M(jìn)echanicalC./SystemOwner機(jī)械工程師/系統(tǒng)使用者SystemOwner系統(tǒng)使用者2022/12/13Operational運(yùn)行確認(rèn)Installation安VModelLifeCycle2022/12/14VModelLifeCycle2022/12/14URS-systemlevel用戶需求Specifications標(biāo)準(zhǔn)URS用戶需求projectlevel項(xiàng)目層面參數(shù)一覽表Systemlist系統(tǒng)清單Blockdiagram設(shè)計(jì)結(jié)構(gòu)圖紙概括的系統(tǒng)描述PFD流程圖Criticalityanalysis重要項(xiàng)分析MasterValidationPlan驗(yàn)證主計(jì)劃Traceabilitymatrix矩陣圖Goodfordesign用于設(shè)計(jì)2022/12/15URS-systemlevel用戶需求SpecificDesign-Basicdocuments基礎(chǔ)設(shè)計(jì)文件Detailedsystemdescription詳細(xì)系統(tǒng)描述PIDGeneralsystemdescription概括的系統(tǒng)描述PFD流程圖Roomdatasheets–Parameters參數(shù)一覽表Traceabilitymatrix矩陣圖Instrumentlist儀表清單Equipmentlist設(shè)備清單Parameterlist參數(shù)清單Alarmlist報(bào)警項(xiàng)目清單Goodforconstruction用于制造Traceabilitymatrix矩陣圖2022/12/16Design-Basicdocuments基礎(chǔ)設(shè)計(jì)文Design&Installation-ACS/Software

設(shè)計(jì)及安裝－軟件Detailedsystemdescription詳細(xì)系統(tǒng)描述Parameterlist參數(shù)清單Alarmlist報(bào)警項(xiàng)目清單PIDInstrumentlist儀表清單Equipmentlist設(shè)備清單Traceabilitymatrix矩陣圖Softwaredesignconcept軟件概念設(shè)計(jì)Testplan測試計(jì)劃TestdocumentsFAT設(shè)備生產(chǎn)廠測試文件Programreviewreport回顧報(bào)告Applicationsoftware應(yīng)用軟件ReadyforFATTraceabilitymatrix矩陣圖2022/12/17Design&Installation-ACS/SoReadyforFAT進(jìn)入設(shè)備生產(chǎn)廠測試階段Design&Installation-ACS/Hardware

設(shè)計(jì)及安裝－硬件Detailedsystemdescription詳細(xì)的系統(tǒng)描述Parameterlist參數(shù)清單Alarmlist報(bào)警清單PIDInstrumentlist儀表清單Equipmentlist設(shè)備清單Traceabilitymatrix矩陣圖Hardwaredesignconcept硬件概念設(shè)計(jì)I/OlistI/O清單Addresslist地址清單DatasheetsInstruments儀表一覽表PLCconfigurationPLC配置Electricaldrawings電氣圖Controlpanels控制面板Instruments儀表Traceabilitymatrix矩陣圖2022/12/18ReadyforFATDesign&InstallaDesign&Installation–Mechanical

設(shè)計(jì)&安裝－機(jī)械部分Detailedsystemdescription詳細(xì)的系統(tǒng)描述Parameterlist參數(shù)清單Alarmlist報(bào)警清單PIDInstrumentlist儀表清單Equipmentlist設(shè)備清單Traceabilitymatrix矩陣圖Powerdistribution電路分配Airducting空調(diào)管路Piping管道Airductinglayout空調(diào)管路圖Electricallayout電氣圖Equipmentlayout設(shè)備圖Pipinglayout管道圖DatasheetsEquipment設(shè)備一覽表Equipment設(shè)備ReadyforSAT進(jìn)入SATReadyforFAT進(jìn)入FAT2022/12/19Design&Installation–MechanTesting-FATsoftware

測試－FAT軟件部分Traceabilitymatrix矩陣圖Applicationsoftware應(yīng)用軟件FAT測試文件FATprocedures程序FATprotocols方‘案FactoryAcceptanceTest設(shè)備生產(chǎn)廠測試SoftwareFATreport軟件部分測試報(bào)告Software軟件2022/12/110Testing-FATsoftware

測試－FAT軟Testing-FAThardware

測試－FAT硬件部分Traceabilitymatrix矩陣圖Electricalpanels儀表板TestdocumentsFAT測試文件FATprocedures程序FATprotocols方案FactoryAcceptanceTest設(shè)備生產(chǎn)廠測試hardwareFATreport硬件的FAT報(bào)告Hardware硬件Instruments儀表Calibrationcertificates校驗(yàn)證書2022/12/111Testing-FAThardware

測試－FAT硬Testing-FATEquipment

測試－FAT設(shè)備部分Traceabilitymatrix矩陣圖Equipment設(shè)備TestdocumentsFAT測試文件FATprocedures程序FATprotocols方案FactoryAcceptanceTest設(shè)備生產(chǎn)廠測試EquipmentFATreport設(shè)備的FAT報(bào)告Equipment設(shè)備Certificates合格證書2022/12/112Testing-FATEquipment

測試－FATFieldinstallationverification

現(xiàn)場安裝確認(rèn)Traceabilitymatrix矩陣圖Systeminstallation系統(tǒng)安裝Designdocuments設(shè)計(jì)文件IOtestprotocolIO測試方案Tightnesstestprotocols嚴(yán)密的測試方案FieldinstallationverificationReport現(xiàn)場安裝確認(rèn)報(bào)告System系統(tǒng)FieldInstallationVerification現(xiàn)場安裝確認(rèn)2022/12/113FieldinstallationverificatioApproval1

批準(zhǔn)SoftwareFATreport軟件的FAT報(bào)告HardwareFATreport硬件的FAT報(bào)告EquipmentFATreport設(shè)備FAT報(bào)告Fieldinstallationverificationreport現(xiàn)場安裝報(bào)告Approved批準(zhǔn)ReadyforSAT進(jìn)入SAT2022/12/114Approval1

批準(zhǔn)SoftwareFATrepoTesting-SATsoftware

測試－SAT軟件Traceabilitymatrix矩陣圖Applicationsoftware應(yīng)用軟件TestdocumentsSATSAT測試文件SATprocedures程序SATprotocols方案SiteAcceptanceTest工廠測試SoftwareSATreport軟件SAT報(bào)告Software軟件2022/12/115Testing-SATsoftware

測試－SATTesting-SATequipment

測試－SAT設(shè)備部分Traceabilitymatrix矩陣圖Equipment設(shè)備TestdocumentsSATSAT測試文件SATprocedures程序SATprotocols方案SiteAcceptanceTest工廠測試EquipmentSATreport設(shè)備SAT報(bào)告Equipment設(shè)備Certificates合格證書2022/12/116Testing-SATequipment

測試－SATApproval2SoftwareSATreport軟件SAT報(bào)告EquipmentSATreport設(shè)備SAT報(bào)告ReadyforPerformancetesting進(jìn)入性能測試Approved

批準(zhǔn)2022/12/117Approval2SoftwareSATreportESystems1System=1PIDExample如: 1airhandlingunit一個空調(diào)單元 1cleansteamgenerator一個清潔蒸汽發(fā)生器 3holdingtanks三個儲罐Asystemisacompositionofcomponentsthatlogicallycohereinordertofulfilaparticularfunctionality一個系統(tǒng)是由多個單元組成的復(fù)合體，各單元組合在一起而完成特定的功能2022/12/118Systems1System=1PIDExamplTraceability

追溯性Projectdocumentsmustbetraceabletorequirements項(xiàng)目文件必須有追溯性

DesigndocumentsmustbetraceabletoURS設(shè)計(jì)文件對應(yīng)于URSTestingmustbetraceabletodesignspecificationandURS測試對應(yīng)于設(shè)計(jì)標(biāo)準(zhǔn)和URSURSprojectlevelURS項(xiàng)目層面URSsystemlevelURS系統(tǒng)層面DesignDocuments設(shè)計(jì)文件Tests測試Useofatraceabilitymatrixistherecommendedmethod推薦用追溯性的矩陣圖2022/12/119Traceability

追溯性ProjectdocumeCriticality

關(guān)鍵CriticalityAnalysisisessentialtogoodproject重要性分析是一個好項(xiàng)目成功的關(guān)鍵intendedtofocuseffortonmostcriticalareasforGXP最重要的是GXP的符合性GLPGCPGMPURSCriticalityAnalysis重要性分析URSupdate更新用戶需求SOP程序Detailedsystemdescription詳細(xì)的系統(tǒng)描述ComparesGXPwithURSparagraphs逐段比對URS與GXP符合性DefinesactionsforProjectandOwne項(xiàng)目組和用戶確定必要的行動rHighlightsSOPandDSDcontrols簡述SOP與系統(tǒng)描述中重點(diǎn)2022/12/120Criticality

關(guān)鍵CriticalityAnal設(shè)備驗(yàn)證2008年11月2022/12/121設(shè)備驗(yàn)證2008年11月2022/12/11Validation驗(yàn)證“Establishingdocumentedevidencewhichprovidesahighdegreeofassurancethataspecificprocesswillconsistentlyproduceaproductmeetingitspredeterminedspecificationsandqualityattributes”. 建立一個文件化的證據(jù),以提供一個高水準(zhǔn)的保證體系,確保生產(chǎn)出的產(chǎn)品始終符合預(yù)定的標(biāo)準(zhǔn)和質(zhì)量要求。

FDAGuidelinesonGeneralPrinciplesofProcessValidation,May1987.Documents文件2022/12/122Validation驗(yàn)證“EstablishingdocuOperational運(yùn)行確認(rèn)QualificationInstallation安裝確認(rèn)QualificationDesignQualification設(shè)計(jì)確認(rèn)Sequenceofdocuments文件建立次序SpecificationQualification標(biāo)準(zhǔn)確認(rèn)-URS用戶需求

-SpecificationsSystem設(shè)計(jì)基礎(chǔ)文件設(shè)計(jì)&安裝-Mechanical機(jī)械A(chǔ)irunit空調(diào)Electrical電設(shè)計(jì)&安裝Hardware硬件Software軟件IQ安裝確認(rèn)-ACSHardware硬件Software軟件IQ安裝確認(rèn)-Mechanical機(jī)械A(chǔ)irunit空調(diào)Electrical電OQ運(yùn)行確認(rèn)-ACSHardware硬件Software軟件OQ運(yùn)行確認(rèn)-Mechanical機(jī)械A(chǔ)irunit空調(diào)Electrical電PerformanceQualification性能確認(rèn)-SystemSystemOwner系統(tǒng)使用者EngineeringC.工程部ACSC計(jì)算機(jī)工程師.Mech.C.機(jī)械工程師ACSC./SystemOwner計(jì)算機(jī)工程師/系統(tǒng)使用者M(jìn)echanicalC./SystemOwner機(jī)械工程師/系統(tǒng)使用者SystemOwner系統(tǒng)使用者2022/12/123Operational運(yùn)行確認(rèn)Installation安VModelLifeCycle2022/12/124VModelLifeCycle2022/12/14URS-systemlevel用戶需求Specifications標(biāo)準(zhǔn)URS用戶需求projectlevel項(xiàng)目層面參數(shù)一覽表Systemlist系統(tǒng)清單Blockdiagram設(shè)計(jì)結(jié)構(gòu)圖紙概括的系統(tǒng)描述PFD流程圖Criticalityanalysis重要項(xiàng)分析MasterValidationPlan驗(yàn)證主計(jì)劃Traceabilitymatrix矩陣圖Goodfordesign用于設(shè)計(jì)2022/12/125URS-systemlevel用戶需求SpecificDesign-Basicdocuments基礎(chǔ)設(shè)計(jì)文件Detailedsystemdescription詳細(xì)系統(tǒng)描述PIDGeneralsystemdescription概括的系統(tǒng)描述PFD流程圖Roomdatasheets–Parameters參數(shù)一覽表Traceabilitymatrix矩陣圖Instrumentlist儀表清單Equipmentlist設(shè)備清單Parameterlist參數(shù)清單Alarmlist報(bào)警項(xiàng)目清單Goodforconstruction用于制造Traceabilitymatrix矩陣圖2022/12/126Design-Basicdocuments基礎(chǔ)設(shè)計(jì)文Design&Installation-ACS/Software

設(shè)計(jì)及安裝－軟件Detailedsystemdescription詳細(xì)系統(tǒng)描述Parameterlist參數(shù)清單Alarmlist報(bào)警項(xiàng)目清單PIDInstrumentlist儀表清單Equipmentlist設(shè)備清單Traceabilitymatrix矩陣圖Softwaredesignconcept軟件概念設(shè)計(jì)Testplan測試計(jì)劃TestdocumentsFAT設(shè)備生產(chǎn)廠測試文件Programreviewreport回顧報(bào)告Applicationsoftware應(yīng)用軟件ReadyforFATTraceabilitymatrix矩陣圖2022/12/127Design&Installation-ACS/SoReadyforFAT進(jìn)入設(shè)備生產(chǎn)廠測試階段Design&Installation-ACS/Hardware

設(shè)計(jì)及安裝－硬件Detailedsystemdescription詳細(xì)的系統(tǒng)描述Parameterlist參數(shù)清單Alarmlist報(bào)警清單PIDInstrumentlist儀表清單Equipmentlist設(shè)備清單Traceabilitymatrix矩陣圖Hardwaredesignconcept硬件概念設(shè)計(jì)I/OlistI/O清單Addresslist地址清單DatasheetsInstruments儀表一覽表PLCconfigurationPLC配置Electricaldrawings電氣圖Controlpanels控制面板Instruments儀表Traceabilitymatrix矩陣圖2022/12/128ReadyforFATDesign&InstallaDesign&Installation–Mechanical

設(shè)計(jì)&安裝－機(jī)械部分Detailedsystemdescription詳細(xì)的系統(tǒng)描述Parameterlist參數(shù)清單Alarmlist報(bào)警清單PIDInstrumentlist儀表清單Equipmentlist設(shè)備清單Traceabilitymatrix矩陣圖Powerdistribution電路分配Airducting空調(diào)管路Piping管道Airductinglayout空調(diào)管路圖Electricallayout電氣圖Equipmentlayout設(shè)備圖Pipinglayout管道圖DatasheetsEquipment設(shè)備一覽表Equipment設(shè)備ReadyforSAT進(jìn)入SATReadyforFAT進(jìn)入FAT2022/12/129Design&Installation–MechanTesting-FATsoftware

測試－FAT軟件部分Traceabilitymatrix矩陣圖Applicationsoftware應(yīng)用軟件FAT測試文件FATprocedures程序FATprotocols方‘案FactoryAcceptanceTest設(shè)備生產(chǎn)廠測試SoftwareFATreport軟件部分測試報(bào)告Software軟件2022/12/130Testing-FATsoftware

測試－FAT軟Testing-FAThardware

測試－FAT硬件部分Traceabilitymatrix矩陣圖Electricalpanels儀表板TestdocumentsFAT測試文件FATprocedures程序FATprotocols方案FactoryAcceptanceTest設(shè)備生產(chǎn)廠測試hardwareFATreport硬件的FAT報(bào)告Hardware硬件Instruments儀表Calibrationcertificates校驗(yàn)證書2022/12/131Testing-FAThardware

測試－FAT硬Testing-FATEquipment

測試－FAT設(shè)備部分Traceabilitymatrix矩陣圖Equipment設(shè)備TestdocumentsFAT測試文件FATprocedures程序FATprotocols方案FactoryAcceptanceTest設(shè)備生產(chǎn)廠測試EquipmentFATreport設(shè)備的FAT報(bào)告Equipment設(shè)備Certificates合格證書2022/12/132Testing-FATEquipment

測試－FATFieldinstallationverification

現(xiàn)場安裝確認(rèn)Traceabilitymatrix矩陣圖Systeminstallation系統(tǒng)安裝Designdocuments設(shè)計(jì)文件IOtestprotocolIO測試方案Tightnesstestprotocols嚴(yán)密的測試方案FieldinstallationverificationReport現(xiàn)場安裝確認(rèn)報(bào)告System系統(tǒng)FieldInstallationVerification現(xiàn)場安裝確認(rèn)2022/12/133FieldinstallationverificatioApproval1

批準(zhǔn)SoftwareFATreport軟件的FAT報(bào)告HardwareFATreport硬件的FAT報(bào)告EquipmentFATreport設(shè)備FAT報(bào)告Fieldinstallationverificationreport現(xiàn)場安裝報(bào)告Approved批準(zhǔn)ReadyforSAT進(jìn)入SAT2022/12/134Approval1

批準(zhǔn)SoftwareFATrepoTesting-SATsoftware

測試－SAT軟件Traceabilitymatrix矩陣圖Applicationsoftware應(yīng)用軟件TestdocumentsSATSAT測試文件SATprocedures程序SATprotocols方案SiteAcceptanceTest工廠測試SoftwareSATreport軟件SAT報(bào)告Software軟件2022/12/135Testing-SATsoftware

測試－SATTesting-SATequipment

測試－SAT設(shè)備部分Traceabilitymatrix矩陣圖Equipment設(shè)備TestdocumentsSATSAT測試文件SATprocedures程序SATprotocols方案SiteAcceptanceTest工廠測試EquipmentSATreport設(shè)備SAT報(bào)告Equipment設(shè)備Certificates合格證書2022/12/136Testing-SATequipment

測試－SATApproval2SoftwareSATreport軟件SAT報(bào)告EquipmentSATreport設(shè)備