Title21fChapterI—SubchapterAfPartllTITLE21一FoodandDrugs食品和药品CHAPTERI—FOODANDDRUGADMINISTRATION,DEPARTMENTOFHEALTHANDHUMANSERVICES食品药品管理局，卫生福利部SUBCHAPTERA—GENERAL通则PART11—ELECTRONICRECORDS;ELECTRONICSIGNATURES电子记录，电子签名Sec.11.1Scope.范围(a)Theregulationsinthispartsetforththecriteriaunderwhichtheagencyconsiderselectronicrecords,electronicsignatures,andhandwrittensignaturesexecutedtoelectronicrecordstobetrustworthy,reliable,andgenerallyequivalenttopaperrecordsandhandwrittensignaturesexecutedonpaper.本部分的规定设定了FDA认为电子记录、电子签名和对电子记录所实施的手写签名可靠可信，并且通常等同于纸质记录和在纸上手书签名的标准。(b)Thispartappliestorecordsinelectronicformthatarecreated,modified,maintained,archived,retrieved,ortransmitted,underanyrecordsrequirementssetforthinagencyregulations.ThispartalsoappliestoelectronicrecordssubmittedtotheagencyunderrequirementsoftheFederalFood,Drug,andCosmeticActandthePublicHealthServiceAct,evenifsuchrecordsarenotspecificallyidentifiedinagencyregulations.However,thispartdoesnotapplytopaperrecordsthatare,orhavebeen,transmittedbyelectronicmeans.本部分适用于依FDA法规中设定的记录要求创建、修改、维护、归档、检索或传送的电子形式记录。本部分也适用于依《联邦食品药品化妆品法案》和《公众健康服务法案》要求提交给FDA的电子记录，即使此记录未在FDA法规中明确被识别。但是，此部分不适用于将采用或已采用电子方式传输的纸质记录。(c)Whereelectronicsignaturesandtheirassociatedelectronicrecordsmeettherequirementsofthispart,theagencywillconsidertheelectronicsignaturestobeequivalenttofullhandwrittensignatures,initials,andothergeneralsigningsasrequiredbyagencyregulations,unlessspecificallyexceptedbyregulation(s)effectiveonorafterAugust20,1997.如果电子签名和与它相关的电子记录符合本部分的要求,FDA将会认为电子签名等同于完全手写签名、缩写签名和其他的FDA法规所求的一般签名，1997年8月20日之后生效的法规明确排除者除外。(d)Electronicrecordsthatmeettherequirementsofthispartmaybeusedinlieuofpaperrecords,inaccordancewith§11.2,unlesspaperrecordsarespecificallyrequired.除特别要求使用纸质记录者外，依据§11.2，符合本部分要求的电子记录可用以替代纸质记录。(e)Computersystems(includinghardwareandsoftware),controls,andattendantdocumentationmaintainedunderthispartshallbereadilyavailablefor,andsubjectto,FDAinspection.依本部分要求维护的计算机系统(包括硬件和软件)、控制权、和随附的文件在FDA检查期间应可以提供。(f)Thispartdoesnotapplytorecordsrequiredtobeestablishedormaintainedby§§1.326through1.368ofthischapter.Recordsthatsatisfytherequirementsofpart1,subpartJofthischapter,butthatalsoarerequiredunderotherapplicablestatutoryprovisionsorregulations,remainsubjecttothispart.这部分内容不适用于根据本章§§1.326至§§1.368要求而建立或维护的记录。本章1.326部分至1.368部分所要求的记录，如其它适用法律法规条款也需要，则仍须符合本部分要求。(g)Thispartdoesnotapplytoelectronicsignaturesobtainedunder§101.11(d)ofthischapter.本部分不适用于依本章§101.11(d)所获得的电子签名。Thispartdoesnotapplytoelectronicsignaturesobtainedunder§101.8(d)ofthischapter.本部分不适用于依本章§101.8(d)所获得的电子签名。(i)Thispartdoesnotapplytorecordsrequiredtobeestablishedormaintainedbypart117ofthischapter.Recordsthatsatisfytherequirementsofpart117ofthischapter,butthatalsoarerequiredunderotherapplicablestatutoryprovisionsorregulations,remainsubjecttothispart.本部分不适用于根据本章第117部分要求而建立...
