21 CFR PART 11 REGULATIONS RECOMMENDATIONS FORppt课件

21CFRPART11REGULATIONSRECOMMENDATIONSFORCHANGESFDAPUBLICMEETINGONPART11REGULATIONS JUNE11 2004 NATIONALELECTRICALMANUFACTURERSASSOCIATION NEMA RICHARDEATON NEMARAVINABAR PH D EASTMANKODAK NationalElectricalManufacturersAssociation NEMA LargestU S tradeassociationrepresentingAmerica selectroindustry DiagnosticImagingandTherapySystemsDivisionofNEMArepresentsmanufacturersof X ray CT diagnosticultrasound magneticresonance nuclearmedicineimaging radiationtherapyandmedicalimaginginformaticsequipment MemberofPart11Coalition OVERVIEW OriginalintendedobjectivesofPart11Regulations TheProblem Part11DuplicationofPredicateRules NEMApresentationaddressesQuestion3 Part11SubpartBElectronicRecords ProposedSolution OriginalintendedkeyobjectivesofPart11Regulations Retention documentationofrecords Integrity securityofRecords FDAAccesstoRecords AuthenticationofElectronicSignatures AccountabilityforMaintainingRecordsSystem Validation THEPROBLEM DUPLICATION PART11ANDPREDICATERULES Part11Regulations ObjectivescoveredbyPredicateRules Part11Regulationsaretooprescriptive Part11Regulations PredicateRules DuplicativeandConfusing DuplicativeRegulationsareContraryto leastburdensome principlestominimizeexcessregulation PROPOSEDSOLUTIONS ALTERNATIVEA WithdrawPart11RegulationsinfavorofPredicateRulesALTERNATIVEB ChangePart11Regulationsto Guidance document PREDICATERULESADDRESSPART11OBJECTIVES QualitySystemRegulation MedicalDeviceReporting CorrectionsandRemovals GoodLaboratoryPractices QUALITYSYSTEMREGULATIONDUPLICATEDBYPART11REGS PART11REGS 21CFR11 10 a ValidationofSystems 21CFR11 10 b Controls ClosedSystems Generatecopiesofrecordsforinspection 21CFR11 10 c ProtectionofRecordstoenableretrievalLIMITACCESSTOAUTHORIZEDINDIVIDUALSOPERATIONALSYSTEMCHECKS QSRREGULATION 21CFR820 70 i Production ProcessControls 21CFR820 40 DocumentControls 21CFR820 180 GeneralRequirements 21CFR820 40 820 180 IntentofPredicateRulesisthesameasPart11Regulations butlessprescriptive QUALITYSYSTEMREGULATIONDUPLICATEDBYPART11REGS PART11REGS 21CFR11 10 d LimitAccesstoauthorizedindividuals 21CFR11 10 e Useofcomputer generatedaudittrails QSRREGULATION 21CFR820 40DocumentControls 21CFR820 20Mgmt Responsibility 21CFR820 40DocumentControls QUALITYSYSTEMREGULATIONCOMPAREDWITHPART11REGS Part11REGS 21CFR11 10 f Operationalchecks 21CFR11 10 g Authoritychecks 21CFR11 10 h Devicechecks QSRREGULATION 21CFR820 70Prod Processcontrol 21CFR820 20Mgmt responsibility 21CFR820 25Personnel QUALITYSYSTEMREGULATIONDUPLICATEDBYPART11REGS PART11REGS 21CFR11 10 i Education personnel 21CFR11 10 j Accountability 21CFR11 10 k Controls systemdocumentation QSRREGULATION 21CFR820 25Personnel 21CFR820 20Mgmt Responsibility 21CFR820 40DocumentControls MEDICALDEVICEREPORTINGREGULATIONCOMPAREDWITHPART11REGULATIONS PART11REGS 21CFR11 10 b Controls generatecopiesofrecordsforinspection21CFR11 10 c Protectionofrecordstoenableretrieval MDRREGULATION 21CFR803 1MaintainRecords MEDICALDEVICEREPORTINGREGULATIONCOMPAREDWITHPART11REGULATIONS PART11REGS 21CFR11 10 b Controls 21CFR11 10 b Controls 21CFR11 10 k Controls SystemDocumentation MDRREGULATION 21CFR803 10RequiredReports 21CFR803 14ElectronicReporting 21CFR803 17WrittenMDRProcedures MEDICALDEVICEREPORTINGREGULATIONCOMPAREDWITHPART11REGULATIONS PART11REGS 21CFR11 10 e Audittrails 21CFR11 10 k Controls systemdocumentation MDRREGULATION 21CFR803 18File DistributorReports MDRevents CORRECTIONSANDREMOVALSREGULATIONCOMPAREDWITHPART11REGULATIONS PART11REGS 21CFR11 10 b Controls21CFR11 10 c ProtectionofRecords CORRECT ANDREMOVALSREG 21CFR806 1MaintainRecords CORRECTIONSANDREMOVALSREGULATIONCOMPAREDWITHPART11REGULATIONS PART11REGS 21CFR11 10 b Controls CORRECT ANDREMOVALSREG 21CFR806 10CorrectionsandRemovalsReports CORRECTIONSANDREMOVALSREGULATIONCOMPAREDWITHPART11REGULATIONS PART11REGS 21CFR11 10 b Controls CORRECT ANDREMOVALSREG 21CFR806 30FDAAccesstoRecords GOODLABORATORYPRACTICEREGULATIONCOMPAREDWITHPART11REGULATIONS PART11REGS 21CFR11 10 b Recordsforinspection 21CFR11 10 i Education trainingofpersonnel GOODLAB PRACTICEREG 21CFR58 15Inspectionofrecords 21CFR58 29Personnel educationandtraining GOODLABORATORYPRACTICEREGULATIONCOMPAREDWITHPART11REGULATIONS PART11REGS 21CFR11 10 c Protectionofrecords 21CFR11 10 k Appropriatecontrolsoversystemdocumentation GOODLAB PRACTICEREG 21CFR58 33StudyDirector responsibilityfordocumentation GOODLABORATORYPRACTICEREGULATIONCOMPAREDWITHPART11REGULATIONS PART11REGS 21CFR11 10 g authoritysystemchecks21CFR11 10 k Appropriatecontrolsoversystemdocumentation 21CFR11 30Controlsoveropensystems GOODLAB PRACTICEREG 21CFR58 35QualityAssuranceUnit GOODLABORATORYPRACTICEREGULATIONCOMPAREDWITHPART11REGULATIONS PART11REGS 21CFR11 10 c Controlsoversystemdocumentation GOODLAB PRACTICEREG 21CFR58 81Writtenstandardoperatingprocedures GOODLABORATORYPRACTICEREGULATIONCOMPAREDWITHPART11REGULATIONS PART11REGS 21CFR11 10 c Protectionofrecords 21CFR11 10 k Appropriatecontrolsoversystemdocumentation GOODLAB PRACTICEREG 21CFR59 190Storageandretrievalofrecords GOODLABORATORYPRACTICEREGULATIONCOMPAREDWITHPART11REGULATIONS PART11REGS 21CFR11 10 c Protectionofrecords 21CFR11 10 k Appropriatecontrolsforsystemdocumentation GOODLAB PRACTICEREG 21CFR58 195Retentionofrecords PREDICATERULES AcceptancebyFDAandIndustry PartofEstablishedProductApprovalProcess PartofLong EstablishedMedicalDeviceGMPPractice AdequatelyProtectsPublicHealth Comprehensive Coversallphasesofproductdesign development manufactureandcorrectionandproblemreporting CONCLUSIONANDRECOMMENDA