21CFRPart11-中英对照Self整理

[Code of Federal Regulations] [联邦法规]

[Title 21, Volume 1] [ 第21

章第1 卷]

[Revised as of April 1, 2006] [2006 年

04月01日修改]

[CITE: 21CFR 11] [ 代

号：21CFR 11]

TITLE 21--Food And Drugs 第21 章

－食品与药品

CHAPTERI--Food And Drug

Administration

第1 节－食品和药品管理局

Department of Health And Human

Services

健康与人类服务部

Subchapter A--General

亚节－一般规定

第11 款电子记录；电子签名PART 11 Electronic Records; Electronic

Signatures

Subpart A--General Provisions 分章A 一

般规定

Sec. 11.1 Scope.

11.1 适用范围

(a) 本条款的规则提供了标准，在此标准(a) The regulations in this part set forth the

criteria under which the agency considers 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e lectronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy,

上的手写签名。

reliable, and generally equivalent to paper

records and handwritten signatures executed

on paper.

(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。

(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.

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

This part also applies to electronic records

法案》要求下的呈送给FDA的电子记录，

submitted to the agency under requirements of 即使该记录没有在FDA规则下明确识

the Federal Food, Drug, and Cosmetic Act and

别。the Public Health Service Act, even if such

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。r ecords are not specifically identified in agency regulations.

However, this part does not apply to paper

(c) 一旦电子签名和与它相关的电子记r ecords that are, or have been, transmitted by electronic means.

录符合本条款的要求，FDA将会认为电

(c) Where electronic signatures and their 子签名等同于完全手签名、缩写签名、

associated electronic records meet the 和其他的FDA规则所求的一般签名。除

requirements of this part, the agency will

非被从1997 年8 月20 日起（包括该日）

consider the electronic signatures to be

生效后的规则明确地排除在外。

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(d) Electronic records that meet the

requirements of this part may be used in lieu 特殊的要求，符合本条款要求的电子记

of paper records, in accordance with 11.2,

录可以代替纸制记录使用。

unless paper records are specifically

required.

(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。(e) Computer systems (including hardware and software), controls, and attendant documentation maintained under this part

(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。s hall 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

[62 FR 13464，1997 年3 月20 日，在2004 required under other applicable statutory

年12 月9 日的69 FR 71655 中做了修订]

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，(a) For records required to be maintained but

not

submitted to

the agency,

persons may

use

如果符合本条款的要求人们可以使

用,

electronic

records in

lieu of

paper

records or

全部或部分电子记录代替纸制记录或用

electronic

signatures in

lieu of

traditional

电子签名代替传统签名。

signatures,

in whole or

in part,

provided

that

the

requirements

of this part

are met.

(b) For records submitted to the agency, (b) 提交给FDA的电子记录，人们可以使