1、PART 11 Electronic Records; Electronic Signatures第 11 款 电子记录；电子签名Subpart A-General Provisions分章 A 一般规定Sec. 11.1 Scope.11.1 适用范围(a) The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to el
2、ectronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures 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, maintaine
3、d, 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
4、specifically identified in agency regulations. However, this part does not apply to paper records that are, or have been, transmitted by electronic 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
5、手段传送的纸制记录。(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 spe
6、cifically excepted by regulation(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 accordance
7、with 11.2, unless 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 documentation maintained under this part shall be readily available for, and subject to, FDA inspection. 在本条款下维护计算
8、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) 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 stat
9、utory provisions or regulations, remain subject to this part. 62 FR 13464, Mar. 20, 1997, as amended 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.
10、 11.2 Implementation.11.2 履行(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. 需要维
11、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 electronic signatures in lieu of traditional signatures, 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
12、传统签名（手签名）假如：(1) The requirements 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 submission the agency accepts in electronic form. This docket will identify specifically what types of d
13、ocuments 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 wil
14、l 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,
15、media, file formats, and technical protocols) and whether to proceed with the electronic submission.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
16、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 Definitions.11.3 定义(a) The definitions and interpretations of terms contained in section 201 of the act apply to those terms when 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 definition
17、s 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) Agency means the Food and Drug Administration.机构是指美国食品和药品管理局(3) Biometrics means a method of verifying an individuals
18、 identity based on measurement of the individuals physical feature(s) or repeatable action(s) where those features and/or actions are both unique to that individual 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 environment in which system acc
19、ess is controlled 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 signature means an electronic signature based upon cryptographic methods of originator authentication, computed by using a set of ru
20、les and a set of parameters such that the identity of the signer and the integrity 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) Electronic record means any combination of text, graphics, data, audio, pictorial, or other information representation in digital
21、form that is created, modified, maintained, 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) Electronic signature means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized
22、 by an individual to be the legally binding equivalent of the individuals handwritten signature. 电子签名是指一种由一个人执行、采用或批准成为与其个人的手写签名具有相同的法律效力的计算机数据的任意符号或一系列符号的编译(8) Handwritten signature means the scripted name or legal mark of an individual handwritten by that individual and executed or adopted with th
23、e present intention to authenticate a writing in a permanent form. The act of signing with a writing or marking instrument such as a pen or stylus is preserved. The scripted name or legal mark, while conventionally applied to paper, may also be applied to other devices that capture the name or mark.
24、 手签名是指个人的手迹签名或合法的标志，以永久的形式书写真实意图所采纳的个人签名或合法标志。用书写及标志工具（例如一支钢笔或尖笔）的签字行为是被保存的。手写签名或合法的标志当约定俗成地适用于书面上，也可以适用于其它的获取名字及标志的设备。(9) Open system means an environment in which system access is not controlled by persons who are responsible for the content of electronic records that are on the system.开放系统是指一种环境，
25、在此环境中系统的登录不是被那些对系统上电子记录的内容负责的人所控制。Subpart B-Electronic Records子分章 B电子记录Sec. 11.10 Controls for closed systems.11.10 封闭系统的管理Persons who use closed systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, a
26、nd, when appropriate, the confidentiality of electronic records, and to ensure that the signer cannot readily repudiate the signed record as not genuine. Such procedures and controls shall include the following: 人们使用封闭系统来建立、修改、维保、或传送电子记录应该使用设计的能够保证记录真实性、完整性和适当的机密性的程序和控制，以保证签名者不能轻易地否认已经签署的记录是不真实的。这样的
27、程序和控制应包括如下：(a) Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records. 系统的验证以保证准确、可靠、稳定地预期性能，有能力识别无效的和被改变的记录。(b) The ability to generate accurate and complete copies of records in both human readable and electroni
28、c form suitable for inspection, review, and copying by the agency. 确保产生人们易读的和适合 FDA 检查、回顾、和拷贝的电子形式的准确的、完整的记录的副本。Persons should contact the agency if there are any questions regarding the ability of the agency to perform such review and copying of the electronic records.当人们怀疑 FDA 执行这样的电子记录回顾和拷贝的能力时，应
29、该联络 FDA。(c) Protection of records to enable their accurate and ready retrieval throughout the records retention period. 记录的保护以使记录能够在整个的保存期内是准确的和易于检索的。(d) Limiting system access to authorized individuals. 通过授权个人用户以限制系统的登录。(e) Use of secure, computer-generated, time-stamped audit trails to independent
30、ly record the date and time of operator entries and actions that create, modify, or delete electronic records. Record changes shall not obscure previously recorded information.Such audit trail documentation shall be retained for a period at least as long as that required for the subject electronic r
31、ecords and shall be available for agency review and copying. 使用安全的、计算机产生的、时间印记的审核跟踪以便独立地记录操作者登录和建立、修改、或删除电子记录的行为的日期和时间。记录的改变不能使先前的记录信息被覆盖。这样的审核跟踪文档将至少被保留这样一段时间，这取决于从属于的电子记录在 FDA 复查和拷贝时保证是可得到的。(f) Use of operational system checks to enforce permitted sequencing of steps and events, as appropriate. 必要
32、时，使用操作系统检查以加强进程和事件的排序。(g) Use of authority checks to ensure that only authorized individuals can use the system, electronically sign a record, access the operation or computer system input or output device, alter a record, or perform the operation at hand.使用验证检查以保证只有被授权用户才可以使用系统，以电子方式签署记录，使用操作或计算机系统
33、的输入输出设备，改变记录或手工执行操作。(h) Use of device (e.g., terminal) checks to determine, as appropriate, the validity of the source of data input or operational instruction. 必要时使用设备（举例来说，终端）检查以确定数据输入来源或操作指导的有效性。(i) Determination that persons who develop, maintain, or use electronic record/electronic signature sy
34、stems have the education, training, and experience to perform their assigned tasks. 确定开发、维护或使用电子记录/电子签名系统的人员应具备与执行他们被指派的任务相应的教育、培训和经验。(j) The establishment of, and adherence to, written policies that hold individuals accountable and responsible for actions initiated under their electronic signatures
35、, in order to deter record and signature falsification. 为了阻止记录和签名的伪造，确立与坚持源自个人电子签名行为的责任与职责的书面策略。(k) Use of appropriate controls over systems documentation including: 在系统文件方面运用适当的控制包括：(1) Adequate controls over the distribution of, access to, and use of documentation for system operation and maintena
36、nce. 在分发的，有权使用，系统运转和维护方面使用的文件有足够的控制。(2) Revision and change control procedures to maintain an audit trail that documents time-sequenced development and modification of systems documentation.修订和改变控制程序以保持一个以时间顺序产生和修改的系统文件的审核跟踪。Sec. 11.30 Controls for open systems.11.30 开放系统的管理Persons who use open syst
37、ems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, as appropriate, the confidentiality of electronic records from the point of their creation to the point of their receipt.人们使用开放系统来建立、修改、保持、或传送电子记录
38、将使用设计程序和控制以保证电子记录从他们的创建处到他们的接收处的真实性、完整性和机密性。Such procedures and controls shall include those identified in 11.10, as appropriate and additional measures such as document encryption and use of appropriate digital signature standards to ensure, as necessary under the circumstances, record authenticity
39、, integrity, and confidentiality.这种程序和控制应包括那些在 11.10 中被识别的，必要时，附加的测量例如文档的加密术和运用适当的数字签名标准以保证，在此环境下，记录必要的正确性、完整性、和机密性。Sec. 11.50 Signature manifestations.11.50 签名的显示(a) Signed electronic records shall contain information associated with the signing that clearly indicates all of the following: 签署电子记录应包
40、含能清晰显示如下所有与签名相关的信息：(1) The printed name of the signer; 用印刷体书写出签名者的名字(2) The date and time when the signature was executed; and 签名生效的日期和时间；和(3) The meaning (such as review, approval, responsibility, or authorship) associated with the signature. 和签名相关的含意（例如回顾、批准、职责、或原创作者）(b) The items identified in pa
41、ragraphs (a)(1), (a)(2), and (a)(3) of this section shall be subject to the same controls as for electronic records and shall be included as part of any human readable form of the electronic record (such as electronic display or printout).该条款已识别出在这一部分(a)(1)、(a)(2) 和(a)(3)节应服从于和电子记录同样的控制并且应该被包括人们易读的电
42、子记录的形式（例如电子显示或打印输出） 。Sec. 11.70 Signature/record linking.11.70 签名/记录连接Electronic signatures and handwritten signatures executed to electronic records shall be linked to their respective electronic records to ensure that the signatures cannot be excised, copied, or otherwise transferred to falsify an
43、 electronic record by ordinary means.在电子记录上签署的电子签名和手签名应该链接到它们各自的电子记录以保证电子签名不能够被删去、拷贝或者其他方面的转移以至于使用普通手段伪造一个电子记录。Subpart C-Electronic Signatures分章 C 电子签名Sec. 11.100 General requirements.11.100 一般要求(a) Each electronic signature shall be unique to one individual and shall not be reused by, or reassigned
44、 to, anyone else. 每一电子签名应是唯一对应单独一个人的并且不能被再使用、或再分配给其他任何人。(b) Before an organization establishes, assigns, certifies, or otherwise sanctions an individuals electronic signature, or any element of such electronic signature, the organization shall verify the identity of the individual. 在一个组织建立，分配，证明，或批准
45、一个人的电子签名或其他的任何这样的电子签名的要素前，组织将校验个人的身份(c) Persons using electronic signatures shall, prior to or at the time of such use, certify to the agency that the electronic signatures in their system, used on or after August 20, 1997, are intended to be the legally binding equivalent of traditional handwritten
46、 signatures. 签名者使用电子签名前或使用时应向 FDA 证明，从 1997 年 8 月 20 日起及以后在他们系统上的电子签名，与传统的手写签名有同等的法律效力(1) The certification shall be submitted in paper form and signed with a traditional handwritten signature, to the Office of Regional Operations (HFC-100), 5600 Fishers Lane, Rockville, MD 20857. 证明要以书面形式提交到“地方运转办公
47、室” （HFC-100, 5600 Fishers Lane, Rockville, MD 20857）并采用传统的手写签名(2) Persons using electronic signatures shall, upon agency request, provide additional certification or testimony that a specific electronic signature is the legally binding equivalent of the signers handwritten signature.应 FDA 要求，人们在使用电子
48、签名时，应提供一份明确电子签名与签字者手写签名具有同等的法律效力的附加的证明书或证据Sec. 11.200 Electronic signature components and controls.11.200 电子签名的成分及管理(a) Electronic signatures that are not based upon biometrics shall: 不依据生物测定学的电子签名应：(1) Employ at least two distinct identification components such as an identification code and passwor
49、d. 使用至少二种截然不同的证明成分，例如识别码和密码。(i) When an individual executes a series of signings during a single, continuous period of controlled system access, the first signing shall be executed using all electronic signature components; subsequent signings shall be executed using at least one electronic signature component that is only executable by, and designed to be used only by, the individual. 当一个人在一个独立的持续受控的系统登录期间内签署了一系列的签名，签署的第一个签名将使用所有的电子签名成分。后续签署的签名应使用至少一种的电子签名的成分。该成分只能由个人签署，并且设计只能由个人来使用。(ii) When an individual executes one or more signings not performed during a single, continuo
