21cfrpart11-中英对照self整理

[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 Drugs

CHAPTER 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 一般规定适用范围Subpart A--General Provisions Sec. 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(a) The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten

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。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.

(d)依照本条款，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至建立或维护的记录。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(d) Electronic records that meet the requirements of this part may be used in lieu of paper records, in accordance with , 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.