FDA 21 CFR part 11中英文对照版

FDA 21 CFR part 11译文 21 CFR Part 11是针对电子记录和电子签名的FDA法规，对于药厂和医疗器

械使用的众多电子记录和电子签名提供了详尽的要求和规范。

Subpart A--General Provisions

A部分—通用规定

11.1 Scope.

11.1 范围

(a) 本部分的法规制定了接受标准，用于机构评估电子记录、电子签名、电

子记录加手写签名的可信性、可靠性，以及通常等同于纸质记录和手写签名

的形式。 (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 record sand handwritten signatures executed on paper.

(b) 本部分适用于根据法规需求制定的，以电子形式生成、修改、维护、存

档、恢复或传输的任何记录。还适用于提交给监管机构的关于联邦食品、药

品和化妆品以及公共健康服务法案需求的电子记录，即使此类记录不是法

规中特别提到的。但是，本部分不适用于以电子形式传输的纸质记录。 (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. 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) 当电子签名和相关的电子记录符合本部分要求时，机构应认可电子签名

等同于手写签名、缩写和其他法规中要求常用的签名形式，除非是法规自1997年8月20日以来特别强调的情况。 (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) 根据11.2，符合本部分要求的电子记录可以替代纸质记录，除非特别强调需要纸质记录的情况。

(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) 计算机系统（包括硬件和软件）、控制和服务文档应准备好，并接受FDA

的检查。 (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) 本部分不适用于1.326-1.368章节确定所需要的记录。符合本章节第1部

分J子部分要求的记录，如果在其他适用的法规约束下需要的，仍然需要满

足本部分的要求。 (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.

(g)到(o)的翻译省略，对制造商的意义不大。

11.2执行 11.2 Implementation.

(a) 对于需要保持但无需提交机构的记录，只要本部分的要求得到满足，可

以部分或全部使用电子记录代替纸质记录，或电子签名代替传统签名。 (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) 对于提交机构的记录，可以部分或全部使用电子记录代替纸质记录，或

电子签名代替传统签名，前提是： (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) 本部分的要求得到满足； (1) The requirements of this part are met; and

(2) 文档或文档部分已在公共摘要第92S-0251号中识别为机构接受以电子

形式提交的文件类型。这个摘要将特别识别哪些类型的文档或文档部分允

许以电子而不是纸质形式提交，并识别此类型的提交可以用于的接收机构

单位（例如，指定中心、办公室、部门和分支）。对于公共摘要中没有提到

的接收单位，如果文档以电子形式提交将不会被认定为正式文件；纸质形式的这类文件将被认定为正式文件，并且必须要附上任何的电子记录。需要咨

询接收单位，以确定是否以电子形式提交以及提交的细节（例如，传输方法、

媒介、文档格式和技术方案等）。 (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

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 11.3 Definitions.

(a) 在法案201部分中包括的定义和条款解释适用于本部分。 (a) The definitions and interpretations of terms contained in section 201 of the

act apply to those terms when used in this part.