最新-21-CFR-PART-11-企业指南---中英对照

GuidanceforIndustryPart11,ElectronicRecords;ElectronicSignaturesAugust2003Page1of13GuidanceforIndustryPart11,ElectronicRecords;ElectronicSignatures—ScopeandApplicationAugust2003PharmaceuticalCGMPsFDA工业指南联邦法规11部分电子记录和电子签名—范围和应用2003年8月药物CGMPsTABLEOFCONTENTS目录I.Introduction........................................................................................................................................................2II.Background.......................................................................................................................................................3III.Discussion..........................................................................................................................................................5A.OverallApproachtoPart11Requirements.................................................................................................5B.DetailsofApproach-ScopeofPart11........................................................................................................61.NarrowInterpretationofScope.............................................................................................................62.DefinitionofPart11Records................................................................................................................7C.ApproachtoSpecificPart11Requirements................................................................................................91.Validation...............................................................................................................................................92.AuditTrail..............................................................................................................................................93.LegacySystems...................................................................................................................................104.CopiesofRecords................................................................................................................................115.RecordRetention.................................................................................................................................12IV.REFERENCES...............................................................................................................................................13GuidanceforIndustryPart11,ElectronicRecords;ElectronicSignaturesAugust2003Page2of13ThisguidancerepresentstheFoodandDrugAdministration's(FDA's)currentthinkingonthistopic.ItdoesnotcreateorconferanyrightsfororonanypersonanddoesnotoperatetobindFDAorthepublic.Youcanuseanalternativeapproachiftheapproachsatisfiestherequirementsoftheapplicablestatutesandregulations.Ifyouwanttodiscussanalternativeapproach,contacttheFDAstaffresponsibleforimplementingthisguidance.IfyoucannotidentifytheappropriateFDAstaff,calltheappropriatenumberlistedonthetitlepageofthisguidance.I.IntroductionThisguidanceisintendedtodescribetheFoodandDrugAdministration's(FDA’s)currentthinkingregardingthescopeandapplicationofpart11ofTitle21oftheCodeofFederalRegulations;ElectronicRecords;ElectronicSignatures(21CFRPart11).Thisdocumentprovidesguidancetopersonswho,infulfillmentofarequirementinastatuteoranotherpartofFDA'sregulationstomaintainrecordsorsubmitinformationtoFDA,havechosentomaintaintherecordsorsubmitdesignatedinformationelectronicallyand,asaresult,havebecomesubjecttopart11.Part11appliestorecordsinelectronicformthatarecreated,modified,maintained,archived,retrieved,ortransmittedunderanyrecordsrequirementssetforthinAgencyregulations.Part11alsoappliestoelectronicrecordssubmittedtotheAgencyundertheFederalFood,Drug,andCosmeticAct(theAct)andthePublicHealthServiceAct(thePHSAct),evenifsuchrecordsarenotspecificallyidentifiedinAgencyregulations(§11.1).TheunderlyingrequirementssetforthintheAct,PHSAct,andFDAregulations(otherthanpart11)arereferredtointhisguidancedocumentaspredicaterules.Asanoutgrowthofitscurrentgoodmanufacturingpractice(CGMP)initiativeforhumanandanimaldrugsandbiologics,FDAisre-examiningpart11asitappliestoallFDAregulatedproducts.Weanticipateinitiatingrulemakingtochangepart11asaresultofthatre-examination.Thisguidanceexplainsthatwe本指南代表了FDA在此领域的当前思路，它不赋予任何人任何权利，也并非用于约束FDA或公众。您还可以选择使用另一种符合要求和法规的替代方法。对替代方法有任何问题，请与负责实施本指南的相关人员联系；如果您无法确认联系人，可拨打本指南首页中相应的电话号码咨询。1.介绍该指南旨在给出FDA21CFR第11条：电子记录、电子签名的当前思路。为了遵守法规或FDA规定来保存记录或递交文件至FDA，该指南为选择保存记录或电子递交指定文件需要遵守第11条款提供了指导。第11条款适用于在FDA提出的法规要求前提下，以电子表格形式建立、修改、维护、归档、检索或传送记录。本条款也同样适用于《联邦食品、药品和化妆品法案》和《公众健康服务法案》项下递交电子记录至官方，即使该类记录在FDA法规中没有明确规定(§11.1)。“预定法规”指的是在法案（《联邦食品、药品和化妆品法案》）、PHS法案（《公众健康服务法案》）和FDA法规（第11条款除外）中提到的要求。随着人用、动物用药物和生物制剂CGMP意识的发展，FDA重新审核了第11条款因其适用于FDA监管的所有产品。通过复核，FDA将启动立法来修改第11条款。该指南详细解释了第11条款的适用范围。第11条款的审核还在进行中，对于第11条款中的某些要求，FDA打算采取自由裁量权，即正如GuidanceforIndustryPart11,ElectronicRecords;ElectronicSignaturesAugust2003Page3of13willnarrowlyinterpretthescopeofpart11.Whilethere-examinationofpart11isunderway,weintendtoexerciseenforcementdiscretionwithrespecttocertainpart11requirements.Thatis,wedonotintendt