21CFRPart11中英对照Self整理.docx

1、21CFRPart11中英对照Self整理联邦法规第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Code of Federal RegulationsTitle 21， Volume 1Revised as of April 1, 2006CITE: 21CFR 11TITLE 21-Food And DrugsCHAPTER IFood And Drug AdministrationDepartment of Health And Human Services Subchapter A-General第11款

2、电子记录；电子签名PART 11 Electronic Records; Electronic Signatures分章A 一般规定11。1适用范围Subpart AGeneral ProvisionsSec。 11.1 Scope。(a)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)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

3、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)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。（a) The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten

4、signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper。 (b） This part applies to records in electronic form that are created, modified, maintained， archived, retrieved， or transmitted, under any re

5、cords 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。 Howev

6、er, this part does not apply to paper records that are， or have been， transmitted by electronic means。 (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 s

7、ignatures， initials， and other general signings as required by agency regulations, unless specifically excepted by regulation(s） effective on or after August 20, 1997。(d)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)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.(f) 这部分内容不适用于根据本章1.326至1。368

8、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（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

9、) 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) This part does not apply to records required to be established or maintained by 1。326 through 1.368 of this chapt

10、er. 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。 62 FR 13464， Mar。 20, 1997, as amended at 69 FR 71655， Dec. 9, 200411.2履行Sec。 11。2 Implementation。(a)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)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：（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 sig

12、natures, in whole or in part, provided that the requirements of this part are met。 (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） 符合条款的要求；和（2) 提交的文

13、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。（1) The requirements of this part are me

14、t; and （2） The document or parts of a document to be submitted have been identified in public docket No. 92S0251 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 i

15、n 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 elect

16、ronic 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 p

17、roceed with the electronic submission。11。3定义Sec. 11.3 Definitions.(a)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)下列术语的定义同样适用于本条款：(1）法案是指联邦食品、药品、化妆品法案（21 U。S。C。 321-393）(2）机构是指美国食品和药品管理局（3）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）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。(a） T

18、he definitions and interpretations of terms contained in section 201 of the act apply to those terms when used in this part。 (b） The following definitions of terms also apply to this part: （1） Act means the Federal Food, Drug, and Cosmetic Act （secs。 201-903 （21 U。S.C。 321-393)）. （2） Agency means th

19、e Food and Drug Administration。 (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. （4） Closed system means an env

20、ironment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system.（5）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） 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) 电子签名是指一种由一个人执行、采用或批准成为与其

21、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) 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） 开放系统是指一种环境，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。（5) Digital signature means an electronic signature based upon cryptographic methods of orig

22、inator 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. (6) Electronic record means any combination of text, graphics， data, audio， pictorial， or other information representation in digital fo

23、rm that is created， modified, maintained， archived， retrieved, or distributed by a computer system。 （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

24、handwritten signature. （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 p

25、en 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. （9） Open system means an environment in which system access is not controlled by persons who are responsible for the content of elect

26、ronic records that are on the system。子分章B电子记录11.10封闭系统的管理Subpart B-Electronic RecordsSec。 11.10 Controls for closed systems.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。这样的程序和控制应包括如下：(a)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)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

27、、完整的记录的副本。当人们怀疑FDA执行这样的电子记录回顾和拷贝的能力时，应该联络FDA。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

28、 that the signer cannot readily repudiate the signed record as not genuine. Such procedures and controls shall include the following： （a） Validation of systems to ensure accuracy， reliability， consistent intended performance, and the ability to discern invalid or altered records。 （b) The ability to

29、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 electroni

30、c records。(c)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)通过授权个人用户以限制系统的登录。(e)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)必要时，使用操作系统检查以加强进程和事件的排序。(g)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的输入输出设备，改变记录或手工执行操作.（c) Protect

31、ion of records to enable their accurate and ready retrieval throughout the records retention period. (d) Limiting system access to authorized individuals。 (e) Use of secure， computer-generated， timestamped audit trails to independently record the date and time of operator entries and actions that cr

32、eate， 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。 （f） Use of operational system checks to enforce permitted sequencing of steps and events， as appropriate。 (g） Use of authority checks t