计算机系统验证

©ABBAutomationTechnologiesGoodAutomatedManufacturingPracticeGAMP800xA2006.07.29ABB()()©ABB-2„GAMP?„„„„800xA„©ABB-3GAMP??„„„()„„….GAMP…„„“GoodAutomatedManufacturingPractice”„(VMP)„GxP©ABB-4GAMP:GoodAutomatedManufacturingPractice„„(PLC,DCS,SCADA,FAS),„,„ITsystems,„(LMS),„MES,etc.„ISPEGAMP,GAMPFDA(EMEA.)„GAMPISPEFDA()„GAMP,GAMP4,(GoodPracticeGuides):,,,.©ABB-5„GAMP:„„„„„„:GAMP4„800xA/DCS„“ValidationandprojectexecutionaccordingtoGAMP4”„GAMP4©ABB-6„GAMP?„„„„800xA„©ABB-7Planning()Planning()Specification()Specification()TestPlanning()IQ,OQ,PQTestPlanning()IQ,OQ,PQTesting()IQ,OQ,PQTesting()IQ,OQ,PQReview()Review()„„.„„„,©ABB-8URSURSFSFSDSDSSystemBuildSystemBuildPQPQIQIQOQOQVerifiesVerifiesVerifies©ABB-9:„„,,„„„„„„,„„,„©ABB-10:IQOQSOPPQ©ABB-11IQOQ•••SOPs••••••••(VMP)••••GxP•Part11•••/••••••••••••(SOPs)•SOPs•SOPs••SOPsPQ•••SAT:©ABB-12„GAMP?„„„„800xA„©ABB-13Specifications„,„„:„„„„GAMP4(,)©ABB-14(VMP)„VMP,,.(URS)„,,,.©ABB-15(FS)„,„„P&I„„(DS)„„,,,„,,,©ABB-16SATSATIQIQOQOQPQPQ©ABB-17„GAMP?„„„„800xA„©ABB-18„„„„,,„„„„„„/„©ABB-19„„„„„„„„„„„„„Firmware„©ABB-20„GAMP?„„„„800xA„©ABB-21ABBIT800xA„800xA„FDA21CFRPart11„„,,„?,.„?,.„„Audittrail„Electronicrecording„Electronicsignatures©ABB-22800xAI/Os„„„„DCS/PLC„800xAI/O:„AC800M„S800I/O„S900I/O(Ex)„HART,ProfibusPA/DP,FOUNDATIONFieldbusH1/HSE„IEC61131-3„AutomationNetwork©ABB-23AutomationNetwork„„„„„„„„PAT„FieldbusPLCs/PackageUnits©ABB-24System800xA:Makingplant-widecontroleasierMCCVariableSpeedDrivesS800I/OS900I/O(Ex)WorkplacesControlNetworkRemoteClientsSystemServersFieldbusHighSpeedLinkingDevices(FFHSE/H1,PBDP/PA)ProcessAutomationOperatorEngineeringMaintenanceElectronicRecordingBatchManagemetProductionmanagementMESAssetManagementManufacturingAutomationPLCPLCPackageUnitControl©ABB-25WirelessRIOServerACH550ACH550RoomDisplayControlNetworkClient/serverNetworkPlantNetwork/IntranetLonWorksDevices(VAV)**=ApplicationSpecificControllerMobileOperatorSMSMessagesFASControllerRFBaseNetworkControlModuleSM3000EIBi-BusWorkplaceWorkplaceEMS-RefRelayRIOFASPASSub-systems-Security/Access-LifeSafety-Fire/Smoke-Lighting-EnergyManagementDX-DDCDX-DDCDDCDDCDDCDDC***ACH550NoneGxPGxP*=Building&CustomApplicationController***HVAC©ABB-26„„„„„„„„„„Betterquality©ABB-27:„„,,,CMMS()„IT(PCs,)„„„„„CalibrationCertificate©ABB-28„,„„„„„„„„„©ABB-29800xA21CFRPart11集成FDA21CFRPart11要求使得:„„„„„„„©ABB-30„„xxx„„ID„„„„Audittrail:„©ABB-31„„„„„„©ABB-32„„„„„„„„,„Audittrail©ABB-33:ElectronicAuditTrail„„800xA:„„„„„„„„„…::::::/©ABB-34„GAMP?„„„„800xA„©ABB-35ABB:„„FDA-/GMP,„ABB„FDA-/GMP„„„,,„©ABB-36ABB:„800xA„,„„„/„„„MES/EBR„(FAS)„(PAT)„„©ABB-37ABB:I/O/(PLC,DCS,Scada)©ABB-38ABB:„„,„„„„„„IEC61131-3„„„I/Os(,Zone1)21CFR11©ABB-39ABB:PATPAT„„„„„„„„„„„©ABB-40„„GAMP„„„SOP„DQ/IQ/OQ/PQ„21CFRPart11„„„„FDA/EMEA©ABB-41AutomationSystemsValidationAutomationNetworkPLCs/PackageUnitsABBvalidationassistance:„„GAMP„„„SOP„„21CFRPart11„©ABB-42ComputerInfrastructureQualification:„,,„„,:„,„„„„„©ABB-43ComputerInfrastructureQualificationABB’sregulatorycomplianceassistance:„„„„„„„ProjectValidationMasterPlanITQualificationMasterPlanApplicationValidationPlanServerQualificationPlanNetworkQualificationPlanDesktopBuildQualificationPlanValidationReportQualificationReport©ABB-44ElectronicRecordsandSignaturesFDA21CFRPart11appliestoelectronicrecordsandsignatures.Keyareasoftheregulation:„„„Audittrails„„„©ABB-45ABB’sregulatorycomplianceassistance:„Part11„Part11„Part11„„FDA21CFRPart11appliestoelectronicrecordsandsignatures.ElectronicRecordsandSignatures©ABB-46SpreadsheetValidation„GxPMicrosoftExcel?„„„„„„GxPExcel:„GxP©ABB-47SpreadsheetValidationABB’sregulatorycomplianceassistance:Excel:„„„„DaCS„,„„IQ,OQ„„„OurpartnerWimmerSystemsprovidestheDaCSTMtechnologythatenablesExceltobeusedinregulatedenvironments.©ABB-48BusinessSystemsValidation:„:„CMMS„„(ERP,e.g.SAP)„LIMS„GxPGxP„„SOP©ABB-49BusinessSystemsValidationABB’sregulatorycomplianceassistance:Wehelpyoutoimplementnewtechnologiesandstillmaintaincompliantsystems:„21CFRPart11assessment„Businessreadinessevaluation„Cut-overplanningandmanagement„GxPassessment„Projectmanagement„Riskandgapanalyis„Systemretirementplanning„Validationandimplementation©ABB-50FacilityandEquipmentValidationGMPfacilityandequipmentissues:„,,,„,,….GMP:„„HVAC„„„©ABB-51FacilityandEquipmentValidationABB’scomplianceassistance:WecoverkeyvalidationphasesandGMPissues:„Requirementphase„Validationplanning„Projectteamformation„„GMP„„(IQ,OQ,PQ)„„„©ABB-52EducationandTrainingCourses,forexample:„21CFRPart11„BusinessSystemValidation„CleaningValidation„ComputerValidation„EquipmentandFacilityValidation„GAMP4„GMPFundamentals„InfrastructureQualification„Risk-based21CFRPart11Compliance„StandardOperationProceduresforGMPOperations„SpreadsheetValidationWell-trainedemployeesareessentialforyourbusinessplanning©ABB-53OutsourcingValidationTakingthenextstep„cGMP?„?ABB.Benefits:„—„„©ABB-54Power&ProductivityforaBetterWorldWorkingwiththerightpartnerTurningideasintosolutionsTurningsolutionsintoprofits©[e-mail]