联邦法规：21CFRPart11“电子大数据,电子签名,审计追踪”中英对照

联邦法规：21CFRPart11“电子大数据,电子签名,审计追踪”
中英对照
PART 11 Electr onic Records; Electr onic Sign atures
第11款电子记录；电子签名
Subpart A--Ge neral Provisi ons
分章A 一般规定
Sec. 11.1 Scope.
11.1适用范围
(a)The regulati ons in this part set forth the criteria un der which the age ncy con siders
electro nic records, electro nic sig natures, and han dwritte n sig natures executed to electro nic records to be trustworthy, reliable, and gen erally equivale nt to paper records and han dwritte n sig natures executed on paper.
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)This part applies to records in electronic form that are created, modified, maintain ed, archived, retrieved, or tran smitted, un der any records requireme nts set forth in age ncy regulati ons. 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, eve n if such records are not specifically ide ntified in age ncy regulatio ns.
However, this part does not apply to paper records that are, or have bee n, tran smitted
by electr onic means.
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)Where electro nic sig natures and their associated electro nic records meet the requireme nts of this part, the age ncy will con sider the electro nic sig natures to be equivale nt to full han dwritte n sig natures, in itials, and other gen eral sig nings as required by age ncy regulati ons, uni ess specifically excepted by regulatio n(s) effective
on or after August 20, 1997.
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。

(d)Electronic records that meet the requirements of this part may be used in lieu of paper records, in accorda nee with 11.2, uni ess paper records are specifically required.
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)Computer systems (including hardware and software), controls, and attendant
docume ntati on maintained un der this part shall be readily available for, and subject
to, FDA in spect ion.
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。

⑴ 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 requireme nts of part 1, subpart J of this chapter, but that also are required un der other applicable statutory provisi ons or regulati on s, rema in subject to this part.
[62 FR 13464, Mar. 20, 1997, as amen ded at 69 FR 71655, Dec. 9, 2004]
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]
Sec. 11.2 Impleme ntati on.
11.2 履行
(a)For records required to be maintained but not submitted to the agency, persons
may use electr onic records in lieu of paper records or electr onic sig natures in lieu of
traditi onal sig natures, in whole or in part, provided that the requireme nts of this part are met.
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)For records submitted to the agency, persons may use electronic records in lieu of
paper records or electr onic sig natures in lieu of traditi onal sig natures, in whole or in
part, provided that:
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：
(1)The requireme nts of this part are met; and
符合条款的要求；和
(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 submissi on the age ncy accepts in electro nic form.
This docket will ide ntify specifically what types of docume nts or parts of docume nts
are acceptable for submission in electronic form without paper records and the
age ncy recei ving un it(s) (e.g., specific cen ter, office, divisi on, bran ch) to which such submissi ons may
be made.
Docume nts to age ncy recei ving un it(s) not specified in the public docket will not be con sidered as official if they are submitted in electro nic form; paper forms of such docume nts will be con sidered as official and must accompa ny any electr onic records. Pers ons are expected to con sult with the inten ded age ncy recei ving unit for details on how (e.g., method of tran smissi on, media, file formats, and tech ni cal protocols) and whether to proceed with the electro nic submissi on.
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。

Sec. 11.3 Defin itio ns.
11.3 定义
(a)The defi niti ons and in terpretati ons of terms contained in sect ion 201 of the act
apply to those terms whe n used in this part.
包含于法案201部分中术语的定义和翻译同样适用于那些在本条款中使用到的术语。

(b)The following definitions of terms also apply to this part:
下列术语的定义同样适用于本条款：
(1)Act means the Federal Food, Drug, and Cosmetic Act (secs. 201-903 (21 U.S.C.
321-393)).
法案是指联邦食品、药品、化妆品法案(21 U.S.C. 321-393)
(2)Age ncy means the Food and Drug Adm ini stratio n.
机构是指美国食品和药品管理局
(3)Biometrics means a method of verify ing an in dividual's ide ntity based on
measureme nt of the in dividual's physical feature(s) or repeatable actio n(s) where those features an d/or actions are both unique to that in dividual and measurable.
生物测定学是指一种基于个人的身体特征及重复行为(这些特征和行为对个人来说是唯一的和可以测量的)的测量来校验个人身份的方法。

(4)Closed system means an en vir onment in which system access is con trolled by persons who are responsible for the content of electronic records that are on the system.
封闭的系统是指一种环境，在此环境中系统的登录是被那些对系
统上电子记录的内容负责的人们所控制。

(5)Digital sig nature means an electr onic sig nature based upon cryptographic methods of orig in ator authe nticati on, computed by using a set of rules and a set of parameters such that the ide ntity of the sig ner and the in tegrity of the data can be
verified.
数字签名是指一种基于发信方鉴别加密的方法，使用一套规则和一系列参数计算以使签名者的身份和数据的完整性能被校验
(6)Electro nic record means any comb in ati on of text, graphics, data, audio, pictorial,
or other information representation in digital form that is created, modified, maintain ed, archived, retrieved, or distributed by a computer system.
电子记录是指任何文本、图表、数据、声音、图示的或其他的以电子形式表现的信息的混合，
它的建立、修改、维护、归档、检索或分发是由计算机系统来完成的。

(7)Electr onic sig nature means a computer data compilati on of any symbol or series
of symbols executed, adopted, or authorized by an in dividual to be the legally binding equivale nt of the in dividua I's han dwritte n sig nature.。