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[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
第11款 电子记录；电子签名 分章A 一般规定 11.1适用范围
[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 PART 11 Electronic Signatures Sec. 11.1 Scope.
Records;
Electronic
Subpart A--General Provisions
(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 之下FDA将认为电子记录、电子签名、criteria under which the agency considers
electronic records, electronic signatures, and
和在电子记录上的手签名是可信赖的、
handwritten signatures executed to electronic
可靠的并且通常等同于纸制记录和在纸
records to be trustworthy, reliable, and generally
上的手写签名。 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(b) This part applies to records in electronic form 在任何记录的要求下，以电子表格形式that are created, modified, maintained, archived, 建立、修改、维护、归档、检索或传送retrieved, or transmitted, under any records
requirements set forth in agency regulations. 的记录。
本条款同样适用于在《联邦食品、This part also applies to electronic records
药品和化妆品法案》和《公众健康服务submitted to the agency under requirements of
the Federal Food, Drug, and Cosmetic Act and
法案》要求下的呈送给FDA的电子记
the Public Health Service Act, even if such
录，即使该记录没有在FDA规则下明确records are not specifically identified in agency 识别。 regulations. 然而，本条款不适用于现在和已经However, this part does not apply to paper
records that are, or have been, transmitted by
以电子的手段传送的纸制记录。
electronic means.
(c) Where electronic signatures and their
(c) 一旦电子签名和与它相关的电子记
associated electronic records meet the
录符合本条款的要求，FDA将会认为电
requirements of this part, the agency will
子签名等同于完全手签名、缩写签名、
consider the electronic signatures to be
和其他的FDA规则所求的一般签名。除
equivalent to full handwritten signatures, initials,
非被从1997年8月20日起（包括该日）and other general signings as required by 生效后的规则明确地排除在外。 agency regulations, unless specifically excepted by regulation(s) effective on or after August 20,
1997.
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(d) 依照本条款11.2，除非纸制记录有(d) Electronic records that meet the requirements 特殊的要求，符合本条款要求的电子记of this part may be used in lieu of paper records,
in accordance with 11.2, unless paper records 录可以代替纸制记录使用。
are specifically required.
(e) 在本条款下维护计算机系统（包括硬(e) Computer systems (including hardware and 件和软件）、控制权、和随附的文件应便software), controls, and attendant documentation 于被FDA用到，和服从于FDA的监管。 maintained under this part shall be readily
available for, and subject to, FDA inspection.
(f) 这部分内容不适用于根据本章1.326(f) This part does not apply to records required to 至1.368建立或维护的记录。需要满足be established or maintained by 1.326 through
1.368 of this chapter. Records that satisfy the
第一章（part 1），和本章中子章节J 要
requirements of part 1, subpart J of this chapter,
求的记录，如果同时在其他应用法规或
but that also are required under other applicable
条款中也有要求，则根据这部分内容执
statutory provisions or regulations, remain
行。 subject to this part.
[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]
[62 FR 13464, Mar. 20, 1997, as amended at 69
FR 71655, Dec. 9, 2004] Sec. 11.2 Implementation.
11.2 履行
(a) 需要维护，但不提交给FDA的记录，(a) For records required to be maintained but not 如果符合本条款的要求,人们可以使用submitted to the agency, persons may use
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) 提交给FDA的电子记录，人们可以(b) For records submitted to the agency, persons
使用全部或部分电子记录代替纸制记录may use electronic records in lieu of paper
records or electronic signatures in lieu of
或电子签名代替传统签名（手签名）假
traditional signatures, in whole or in part,
如： provided that: (1) 符合条款的要求；和
(1) The requirements of this part are met; and
(2) 提交的文件或部分文件，作为FDA(2) The document or parts of a document to be
submitted have been identified in public docket
以电子形式接收的提交物的类型已经被
No. 92S-0251 as being the type of submission
编号为92S-0251公共摘要识别出来。 the agency accepts in electronic form.
这个摘要将明确地识别出，何种类This docket will identify specifically what types of 型文件或部分文件在没有纸制记录和documents or parts of documents are acceptable
for submission in electronic form without paper
FDA接收单位（举例来说，特定的中心，
records and the agency receiving unit(s) (e.g.,
办公室，部门、分支机构）时的电子形specific center, office, division, branch) to which 式提交物是可接受的。 such submissions may be made. 如果没有在公共摘要上明确出来，Documents to agency receiving unit(s) not 他们以电子形式提交给FDA接收单位specified in the public docket will not be 的文件将不被认为是正式的；这种文件considered as official if they are submitted in
electronic form; paper forms of such documents
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的书面形式将被认为是正式的但必须伴will be considered as official and must 有电子记录。 accompany any electronic records. 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。 11.3 定义
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. Sec. 11.3 Definitions.
(a) 包含于法案201部分中术语的定义(a) The definitions and interpretations of terms 和翻译同样适用于那些在本条款中使用contained in section 201 of the act apply to those 到的术语。 terms when used in this part. (b) 下列术语的定义同样适用于本条款： (b) The following definitions of terms also apply
to this part: (1) 法案是指联邦食品、药品、化妆品(1) Act means the Federal Food, Drug, and
Cosmetic Act (secs. 201-903 (21 U.S.C. 法案（21 U.S.C. 321-393）
321-393)).
(2) Agency means the Food and Drug (2) 机构是指美国食品和药品管理局
Administration. (3) 生物测定学是指一种基于个人的(3) Biometrics means a method of verifying an 身体特征及重复行为（这些特征和行为individual's identity based on measurement of
the individual's physical feature(s) or repeatable
对个人来说是唯一的和可以测量的）的
action(s) where those features and/or actions are
测量来校验个人身份的方法。 both unique to that individual and measurable. (4) 封闭的系统是指一种环境，在此环(4) Closed system means an environment in
which system access is controlled by persons
境中系统的登录是被那些对系统上电子
who are responsible for the content of electronic
记录的内容负责的人们所控制。 records that are on the system. (5) 数字签名是指一种基于发信方鉴(5) Digital signature means an electronic 别加密的方法，使用一套规则和一系列signature based upon cryptographic methods of
originator authentication, computed by using a
参数计算以使签名者的身份和数据的完
set of rules and a set of parameters such that the
整性能被校验。
identity of the signer and the integrity of the data can be verified.
(6) 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。
(6) Electronic record means any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.
(7) 电子签名是指一种由一个人执(7) Electronic signature means a computer data 行、采用或批准成为与其个人的手写签compilation of any symbol or series of symbols
executed, adopted, or authorized by an
名具有相同的法律效力的计算机数据的
individual to be the legally binding equivalent of
任意符号或一系列符号的编译。 the individual's handwritten signature.
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