淺談計算機設備驗證Validation驗證“Establishingdocumentedevidencewhichprovidesahighdegreeofassurancethataspecificprocesswillconsistentlyproduceaproductmeetingitspredeterminedspecificationsandqualityattributes”. 建立一個文件化的證據(jù),以提供一個高水準的保證體系,確保生產(chǎn)出的產(chǎn)品始終符合預定的標準和質(zhì)量要求。

FDAGuidelinesonGeneralPrinciplesofProcessValidation,May1987.Documents2025/3/152Operational運行確認QualificationInstallation安裝確認QualificationDesignQualification設計確認Sequenceofdocuments文件建立次序SpecificationQualification標準確認-URS用戶需求

-SpecificationsSystem設計基礎文件設計&安裝-Mechanical機械Airunit空調(diào)Electrical電設計&安裝Hardware硬件Software軟件IQ安裝確認-ACSHardware硬件Software軟件IQ安裝確認-Mechanical機械Airunit空調(diào)Electrical電OQ運行確認-ACSHardware硬件Software軟件OQ運行確認-Mechanical機械Airunit空調(diào)Electrical電PerformanceQualification性能確認-SystemSystemOwner系統(tǒng)使用者EngineeringC.工程部ACSC計算機工程師.Mech.C.機械工程師ACSC./SystemOwner計算機工程師/系統(tǒng)使用者MechanicalC./SystemOwner機械工程師/系統(tǒng)使用者SystemOwner系統(tǒng)使用者2025/3/153VModelLifeCycle2025/3/154URS-systemlevel用戶需求Specifications標準URS用戶需求projectlevel項目層面參數(shù)一覽表Systemlist系統(tǒng)清單Blockdiagram設計結構圖紙概括的系統(tǒng)描述PFD流程圖Criticalityanalysis重要項分析MasterValidationPlan驗證主計劃Traceabilitymatrix矩陣圖Goodfordesign用于設計2025/3/155Design-Basicdocuments基礎設計文件Detailedsystemdescription詳細系統(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設備清單Parameterlist參數(shù)清單Alarmlist報警項目清單Goodforconstruction用于制造Traceabilitymatrix矩陣圖2025/3/156Design&Installation-ACS/Software

設計及安裝－軟件Detailedsystemdescription詳細系統(tǒng)描述Parameterlist參數(shù)清單Alarmlist報警項目清單PIDInstrumentlist儀表清單Equipmentlist設備清單Traceabilitymatrix矩陣圖Softwaredesignconcept軟件概念設計Testplan測試計劃TestdocumentsFAT設備生產(chǎn)廠測試文件Programreviewreport回顧報告Applicationsoftware應用軟件ReadyforFATTraceabilitymatrix矩陣圖2025/3/157ReadyforFAT進入設備生產(chǎn)廠測試階段Design&Installation-ACS/Hardware

設計及安裝－硬件Detailedsystemdescription詳細的系統(tǒng)描述Parameterlist參數(shù)清單Alarmlist報警清單PIDInstrumentlist儀表清單Equipmentlist設備清單Traceabilitymatrix矩陣圖Hardwaredesignconcept硬件概念設計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2025/3/158Design&Installation–Mechanical

設計&安裝－機械部分Detailedsystemdescription詳細的系統(tǒng)描述Parameterlist參數(shù)清單Alarmlist報警清單PIDInstrumentlist儀表清單Equipmentlist設備清單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設備圖Pipinglayout管道圖DatasheetsEquipment設備一覽表Equipment設備ReadyforSAT進入SATReadyforFAT進入FAT2025/3/159Testing-FATsoftware

測試－FAT軟件部分Traceabilitymatrix矩陣圖Applicationsoftware應用軟件FAT測試文件FATprocedures程序FATprotocols方‘案FactoryAcceptanceTest設備生產(chǎn)廠測試SoftwareFATreport軟件部分測試報告Software軟件2025/3/1510Testing-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設備生產(chǎn)廠測試hardwareFATreport硬件的FAT報告Hardware硬件Instruments儀表Calibrationcertificates校驗證書2025/3/1511Testing-FATEquipment

測試－FAT設備部分Traceabilitymatrix矩陣圖Equipment設備TestdocumentsFAT測試文件FATprocedures程序FATprotocols方案FactoryAcceptanceTest設備生產(chǎn)廠測試EquipmentFATreport設備的FAT報告Equipment設備Certificates合格證書2025/3/1512Fieldinstallationverification

現(xiàn)場安裝確認Traceabilitymatrix矩陣圖Systeminstallation系統(tǒng)安裝Designdocuments設計文件IOtestprotocolIO測試方案Tightnesstestprotocols嚴密的測試方案FieldinstallationverificationReport現(xiàn)場安裝確認報告System系統(tǒng)FieldInstallationVerification現(xiàn)場安裝確認2025/3/1513Approval1

批準SoftwareFATreport軟件的FAT報告HardwareFATreport硬件的FAT報告EquipmentFATreport設備FAT報告Fieldinstallationverificationreport現(xiàn)場安裝報告Approved批準ReadyforSAT進入SAT2025/3/1514Testing-SATsoftware

測試－SAT軟件Traceabilitymatrix矩陣圖Applicationsoftware應用軟件TestdocumentsSATSAT測試文件SATprocedures程序SATprotocols方案SiteAcceptanceTest工廠測試SoftwareSATreport軟件SAT報告Software軟件2025/3/1515Testing-SATequipment

測試－SAT設備部分Traceabilitymatrix矩陣圖Equipment設備TestdocumentsSATSAT測試文件SATprocedures程序SATprotocols方案SiteAcceptanceTest工廠測試EquipmentSATreport設備SAT報告Equipment設備Certificates合格證書2025/3/1516Approval2SoftwareSATreport軟件SAT報告EquipmentSATreport設備SAT報告ReadyforPerformancetesting進入性能測試Approved

批準2025/3/1517Systems1System=1PIDExle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合體，各單元組合在一起而完成特定的功能2025/3/1518Traceability

追溯性Projectdocumentsmustbetraceabletorequirements項目文件必須有追溯性

DesigndocumentsmustbetraceabletoURS設計文件對應于URSTestingmustbetraceabletodesignspecificationandURS測試對應于設計標準和URSURSprojectlevelURS項目層面URSsystemlevelURS系統(tǒng)層面DesignDocuments設計文件Tests測試Useofatraceabilitymatrixistherecommendedmethod推薦用追溯性的矩陣圖2025/3/1519Criticality

關鍵CriticalityAnalysisisessentialtogoodproject重要性分析是一個好項目成功的關鍵intendedtofocuseffortonmostcriticalareasforGX