21cfr part11-中英对照 self整理.doc

郦无悔 11501555[联邦法规][第 21 章第 1 卷][2006 年 04 月 01 日修改][代号：21CFR 11]第 21 章－食品与药品第 1 节－食品和药品管理局健康与人类服务部亚节－一般规定[Code of Federal Regulations][Title 21, Volume 1][Revised as of April 1, 2006][CITE: 21CFR 11]TITLE 21--Food And DrugsCHAPTER I--Food And Drug Administration　Department of Health And Human Services Subchapter A--General第 11 款　电子记录；电子签名 PART 11 Electronic Records; Electronic Signatures分章 A 一般规定11.1 适用范围Subpart A--General ProvisionsSec. 11.1 Scope.(a) 本条款的规则提供了标准，在此标准之下 FDA 将认为电子记录、电子签名、和在电子记录上的手签名是可信赖的、可靠的并且通常等同于纸制记录和在纸上的手写签名。

b) 本条款适用于在 FDA 规则中阐明的在任何记录的要求下，以电子表格形式建立、修改、维护、归档、检索或传送的记录本条款同样适用于在《联邦食品、药品和化妆品法案》和《公众健康服务法案》要求下的呈送给 FDA 的电子记录，即使该记录没有在 FDA 规则下明确识别然而，本条款不适用于现在和已经以电子的手段传送的纸制记录c) 一旦电子签名和与它相关的电子记录符合本条款的要求，FDA 将会认为电子签名等同于完全手签名、缩写签名、和其他的 FDA 规则所求的一般签名除非被从 1997 年 8 月 20 日起（包括该日）生效后的规则明确地排除在外a) The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. (b) This part applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in agency regulations. This part also applies to electronic records submitted to the agency under requirements of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, even if such records are not specifically identified in agency regulations. However, this part does not apply to paper records that are, or have been, transmitted by electronic means. (c) Where electronic signatures and their associated electronic records meet the requirements of this part, the agency will consider the electronic signatures to be equivalent to full handwritten signatures, initials, and other general signings as required by agency regulations, unless specifically excepted by regulation(s) effective on or after August 20, 1997.郦无悔 11501555(d) 依照本条款 11.2，除非纸制记录有特殊的要求，符合本条款要求的电子记录可以代替纸制记录使用。

e) 在本条款下维护计算机系统（包括硬件和软件） 、控制权、和随附的文件应便于被 FDA 用到，和服从于 FDA 的监管f) 这部分内容不适用于根据本章1.326 至 1.368 建立或维护的记录需要满足第一章（part 1） ，和本章中子章节 J 要求的记录，如果同时在其他应用法规或条款中也有要求，则根据这部分内容执行[62 FR 13464， 1997 年 3 月 20 日， 在2004 年 12 月 9 日的 69 FR 71655 中做了修订](d) Electronic records that meet the requirements of this part may be used in lieu of paper records, in accordance with 11.2, unless paper records are specifically required. (e) Computer systems (including hardware and software), controls, and attendant documentation maintained under this part shall be readily available for, and subject to, FDA inspection. (f) This part does not apply to records required to be established or maintained by 1.326 through 1.368 of this chapter. Records that satisfy the requirements of part 1, subpart J of this chapter, but that also are required under other applicable statutory provisions or regulations, remain subject to this part. [62 FR 13464, Mar. 20, 1997, as amended at 69 FR 71655, Dec. 9, 2004]11.2　履行 Sec. 11.2 Implementation.(a) 需要维护，但不提交给 FDA 的记录，如果符合本条款的要求,人们可以使用全部或部分电子记录代替纸制记录或用电子签名代替传统签名。

b) 提交给 FDA 的电子记录，人们可以使用全部或部分电子记录代替纸制记录或电子签名代替传统签名（手签名）假如：(a) For records required to be maintained but not submitted to the agency, persons may use electronic records in lieu of paper records or electronic signatures in lieu of traditional signatures, in whole or in part, provided that the requirements of this part are met. (b) For records submitted to the agency, persons may use electronic records in lieu of paper records or electronic signatures in lieu of traditional signatures, in whole or in part, provided that:(1) 符合条款的要求；和(2) 提交的文件或部分文件，作为 FDA以电子形式接收的提交物的类型已经被编号为 92S-0251 公共摘要识别出来。

这个摘要将明确地识别出，何种类型文件或部分文件在没有纸制记录和FDA 接收单位（举例来说，特定的中心，办公室，部门、分支机构）时的电子形式提交物是可接受的如果没有在公共摘要上明确出来，(1) The requirements of this part are met; and (2) The document or parts of a document to be submitted have been identified in public docket No. 92S-0251 as being the type of submission the agency accepts in electronic form. This docket will identify specifically what types of documents or parts of documents are acceptable for submission in electronic form without paper records and the agency receiving unit(s) (e.g., specific center, office, division, branch) to which such submissions may be made. 郦无悔 11501555他们以电子形式提交给 FDA 接收单位的文件将不被认为是正式的；这种文件的书面形式将被认为是正式的但必须伴有电子记录。

人们期望与未来的 FDA 接收单位就详细的（举例来说，传送的方法、媒体、文件格式和技术协议）怎样和是否进行电子的提交物进行协商Documents to agency receiving unit(s) not specified in the public docket will not be considered as official if they are submitted in electronic form; paper forms of such documents will be considered as official and must accompany any electronic records. Persons are expected to consult with the intended agency receiving unit for details on how (e.g., method of transmission, media, file formats, and technical protocols) and whether to proceed with the electronic submission.11.3　定义 Sec. 11.3 Def。