-CFR-11-电子记录及电子签名.doc

.Title 21Chapter ISubchapter APart11TITLE 21Food and Drugs食品和药品CHAPTER IFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTHAND HUMAN SERVICES食品药品管理局，卫生福利部SUBCHAPTER AGENERAL通则PART 11ELECTRONIC RECORDS; ELECTRONIC SIGNATURES电子记录，电子签名Sec. 11.1 Scope.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 electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.本部分的规定设定了FDA认为电子记录、电子签名和对电子记录所实施的手写签名可靠可信，并且通常等同于纸质记录和在纸上手书签名的标准。 (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.本部分适用于依FDA法规中设定的记录要求创建、修改、维护、归档、检索或传送的电子形式记录。本部分也适用于依联邦食品药品化妆品法案和公众健康服务法案要求提交给FDA的电子记录，即使此记录未在FDA法规中明确被识别。但是，此部分不适用于将采用或已采用电子方式传输的纸质记录。(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 specifically excepted by regulation(s) effective on or after August 20, 1997.如果电子签名和与它相关的电子记录符合本部分的要求，FDA将会认为电子签名等同于完全手写签名、缩写签名和其他的FDA法规所求的一般签名，1997年8月20日之后生效的法规明确排除者除外。(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.除特别要求使用纸质记录者外，依据11.2，符合本部分要求的电子记录可用以替代纸质记录。(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.依本部分要求维护的计算机系统（包括硬件和软件）、控制权、和随附的文件在FDA检查期间应可以提供。(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.这部分内容不适用于根据本章1.326至1.368要求而建立或维护的记录。本章1.326部分至1.368部分所要求的记录，如其它适用法律法规条款也需要，则仍须符合本部分要求。(g) This part does not apply to electronic signatures obtained under 101.11(d) of this chapter.本部分不适用于依本章101.11(d)所获得的电子签名。 This part does not apply to electronic signatures obtained under 101.8(d) of this chapter.本部分不适用于依本章101.8(d)所获得的电子签名。(i) This part does not apply to records required to be established or maintained by part 117 of this chapter. Records that satisfy the requirements of part 117 of this chapter, but that also are required under other applicable statutory provisions or regulations, remain subject to this part.本部分不适用于根据本章第117部分要求而建立和保存的记录。本章第117部分所要求的记录，如其它适用法律法规条款也需要，则仍须符合本部分要求。(j) This part does not apply to records required to be established or maintained by part 507 of this chapter. Records that satisfy the requirements of part 507 of this chapter, but that also are required under other applicable statutory provisions or regulations, remain subject to this part.本部分不适用于根据本章第507部分要求而建立和保存的记录。本章第507部分所要求的记录，如其它适用法律法规条款也需要，则仍须符合本部分要求。(k) This part does not apply to records required to be established or maintained by part 112 of this chapter. Records that satisfy the requirements of part 112 of this chapter, but that also are required under other applicable statutory provisions or regulations, remain subject to this part.本部分不适用于根据本章第112部分要求而建立和保存的记录。本章第112部分所要求的记录，如其它适用法律法规条款也需要，则仍须符合本部分要求。(l) This part does not apply to records required to be established or maintained by subpart L of part 1 of this chapter. Records that satisfy the requirements of subpart L of part 1 of this chapter, but that also are required under other applicable statutory provisions or regulations, remain subject to this part.本部分不适用于根据本章第1部分第L子部要求而建立和保存的记录。本章第1部分第L子部所要求的记录，如其它适用法律法规条款也需要，则仍须符合本部分要求。(m) This part does not apply to records required to be established or maintained by subpart M of part 1 of this chapter. Records that satisfy the requirements of subpart M of part 1 of this chapter, but that also are required under other applicable statutory provisions or regulations, remain subject to this part.本部分不适用于根据本章第1部分第M子部要求而建立和保存的记录。本章第1部分第M子部所要求的记录，如其它适用法律法规条款也需要，则仍须符合本部分要求。(n) This part does not apply to records required to be established or maintained by subpart O of part 1 of this chapter. Records that satisfy the requirements of subpart O of part 1 of this chapter, but that also are required under other applicable statutory provisions or regulations, remain subject to this part.本部分不适用于根据本章第1部分第O子部要求而建立和保存的记录。本章第1部分第O子部所要求的记录，如其它适用法律法规条款也需要，则仍须符合本部分要求。(o) This part does not apply to records required to be established or maintained by part 121 of this chapter. Records that satisfy the requirements of part 121 of this chapter, but that also are required under other applicable statutory provisions or regulations, remain subject to this part.本部分不适用于根据本章第121部分要求而建立和保存的记录。本章第121部分所要求的记录，如其它适用法律法规条款也需要，则仍须符合本部分要求。Sec. 11.2 Implementation.实施(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.需要维护但不需提交给FDA的记录，如果符合本部分的要求，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:在满足以下条件时，提交给FDA的记录可以全部或部分使用电子记录代替纸制记录或电子签名代替传统签名：(1) The requirements of this part are met; and符合本部分的要求；以及(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.要提交的文件或部分文件在公众文案92S-0251中被列为FDA可以用电子形式提交的文件类型。此文案中会列出哪些类型的文件或文件的哪些部分可以接受电子提交，而不需要纸质记录，以及需要提交给哪个部门（例如，指定的中心、办公室、支部、分部）。在公众文案中未列出的文件如果以电子形式提交，则不会被认为是正式文件，此类文件的纸质文件才是正式文件，必须与电子记录一起提交。申报人可咨询接收文件的FDA部门详细了解要如何提交（例如，传送方法、介质、文件格式和技术方案）以及是否需要同时提交电子申报。Sec. 11.3 Definitions.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.法案第201部分中的术语定义和解释用于本部分时适用于这些术语。(b) The following definitions of terms also apply to this part:下列术语的定义同样适用于本部分：(1)Act means the Federal Food, Drug, and Cosmetic Act (secs. 201-903 (21 U.S.C. 321-393).法案指联邦食品、药品、化妆品法案（第201-903部分（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 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.生物特征识别是指一种通过测量个人唯一且可测量的身体特征及重复行为来核对个人身份的方法。(4)Closed system means an environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system.封闭系统是指系统的进入由对系统上电子记录内容负责的人所控制的环境。(5)Digital signature means an electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules 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认证的加密方法的电子签名，它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核对。(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.电子记录是指文本、图表、数据、声音、图片或其他以数字形式呈现的信息组合，它由计算机系统创建、修改、维护、归档、检索或分布。(7)Electronic signature means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individuals handwritten signature.电子签名是指由个人执行、采用或授权的任何符号或符号系列的计算机数据编译，该签名与个人手书签名具有等同法律效力。(8)Handwritten signature means the scripted name or legal mark of an individual handwritten by that individual and executed or adopted with the 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.手书签名指个人手书的姓名或法定标记，由该人以永久的方式表现真实意图并实际书写。采用书写或记号工具，如钢笔或手写笔签名的动作被留存下来。手书姓名或法定标记，虽然传统地应用于纸张签名，但也可以适用于其它能捕获姓名或标记的装置。(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.开放系统是指系统的进入不由对系统上电子记录内容负责的人所控制的环境。Subpart B-Electronic Records电子记录Sec. 11.10 Controls for closed systems. 封闭系统的控制Persons who use closed systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, 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:使用封闭系统建立、修改、维保或传送电子记录时，应使用设计为可确保电子记录真实性、完整性和保密性（适当时）的程序和控制，以及确保签名者不能轻易否认已经签署记录的真实性。此类程序和控制应包括：(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，以确保其准确性、可靠性、稳定的既定性能，以及识别无效和被篡改记录的能力。(b) The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency. 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.确保生成适合FDA检查、审核和复制的人可读和电子形式的准确完整记录副本的能力。如果对于FDA是否能对其电子记录实施审核和复制存疑，应联系FDA。(c) Protection of records to enable their accurate and ready retrieval throughout the records retention period.对记录进行保护，使其在整个保存期内准确和易于检索。(d) Limiting system access to authorized individuals.将系统进入权限限制于经过授权的人(e) Use of secure, computer-generated, time-stamped audit trails to independently 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 records and shall be available for agency review and copying.使用计算机生成的具有时间戳的安全的审计追踪独立记录操作人员输入的日期和创建、修改和删除电子记录的动作。记录变更不应妨碍读取之前的所记录信息。此审计追踪文件应保存至少与其对应的电子记录所需保存相同时长，并可供FDA审核和复制。(f) Use of operational system checks to enforce permitted sequencing of steps and events, as appropriate.必要时，使用操作系统检查以强化步骤和事件的排序。(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.使用权限检查确保只有经过授权的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的输入输出设备、修改记录和执行操作。(h) Use of device (e.g., terminal) checks to determine, as appropriate, the validity of the source of data input or operational instruction.适当时，使用设备（例如，终端）检查以确定数据输入来源或操作指令的有效性。(i) Determination that persons who develop, maintain, or use electronic record/electronic signature systems have the education, training, and experience to perform their assigned tasks.确定开发、维护和使用电子记录/电子签名系统的人员具备相应的教育、培训和经验完成其指定任务。(j) The establishment of, and adherence to, written policies that hold individuals accountable and responsible for actions initiated under their electronic signatures, in order to deter record and signature falsification.制订并坚守书面方针，要求签字人员对其电子签名所针对的动作承担责任，防止记录和签名伪造。(k) Use of appropriate controls over systems documentation including:对系统文件进行适当的控制包括：(1) Adequate controls over the distribution of, access to, and use of documentation for system operation and maintenance.对系统运行和维护所用文件的分发、获取和使用实施充分的控制。(2) Revision and change control procedures to maintain an audit trail that documents time-sequenced development and modification of systems documentation建立修订和变更控制程序，维护审计追踪记录系统文件的时序开发和修改。Sec. 11.30 Controls for open systems. 开放系统的控制Persons who use open systems 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. 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, integrity, and confidentiality.使用开放系统建立、修改、保持和传送电子记录时，应使用设计以确保电子记录自其创建开始至其接收时为止的真实性、完整性和保密性（适当时）。此类程序和控制应包括11.10中所识别的内容，适当时，还应有其它程序，如文件加密和使用适当的数字签名标准，以确保（如环境必须）记录真实性、完整性和保密性。Sec. 11.50 Signature manifestations. 签名显示(a) Signed electronic records shall contain information associated with the signing that clearly indicates all of the following:所签署的电子记录应清晰显示以下与签名相关的信息：(1) The printed name of the signer; 签名者打印姓名；(2) The date and time when the signature was executed; and签名日期和时间；以及(3) The meaning (such as review, approval, responsibility, or authorship) associated with the signature. 签名含义（如审核、批准、职责或作者身份）。(b) The items identified in paragraphs (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