21CFR Part11-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11.1适用范围Subpart A--General Provisions Sec. 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.

(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，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(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.

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