cfrpart11-中英对照self整理

1、v1.0可编辑可修改联邦法规Code of Federal Regulations第21章第1卷2006年04月01日修改代号:21CFR 11第21章一食品与药品第1节一食品和药品管理局健康与人类服务部Title 21, Volume 1Revised as of April 1,2006CITE: 21CFR 11TITLE 21-Food And DrugsCHAPTERI-Food And Drug Administration第11款电子记录；电子签名PART 11 Electronic Records;SignaturesElectronic分章A檄规定Subpart A-Gene

2、ral Provisions适用范围Sec. Scope.亚节-一般规定(a)本条款的规则提供了标准，在此标准(a) The regulations in this part set forth theDepartment of Health And Human Services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。Subchapter A-General criteria under which the agency considers electronic records, electronic sign

3、atures, and handwritten signatures executed to electronic records to be trustworthy,(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勺电子记录, 即使该记录没有在 FDA规则下明确识reliable, and generally equivalent to paper records and handwritten signatures executed

4、on paper.(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 records17郦无悔submitted to the agency under requirements ofthe F

5、ederal Food, Drug, and Cosmetic Act andthe Public Health Service Act, even if suchHowever, this part does not apply to paperrecords that are, or have been, transmitted by electronic means.(c) Where electronic signatures and their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。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

6、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。records are not specifically identified in agency regulations.associated electronic records meet the requirements of this part, the agency willconsider the electronic signatures to be equivalent to full handwritten signatures, initi

7、als, and other general signings as required by agency regulations, unless specifically excepted by regulation(s)(d)依照本条款，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。effective on or after August 20, 1997.(d) Electronic records that meet therequirements of this part may be used in lieuof paper records, in a

8、ccordance with , unless(e)在本条款下维护计算机系统(包括硬 paper records are specifically required.件和软件)、控制权、和随附的文件应使(e) Computer systems (including hardware and于被FDA用到，和服从于FDA的监管。software),controls,and attendantdocumentation maintained under this part(f)这部分内容不适用于根据本章至建 shall be readily available for, and subject立或

9、维护的记录。需要满足第一章(part to, FDA inspection.1),和本章中子章节J要求的记录，如 (f) This part does not apply to records果同时在其他应用法规或条款中也有要 required to be established or maintained by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of this chapter, but that also are required履行(a)需要维护，但不提交给FDA的记录,under

10、other applicable statutory provisionsor regulations, remain subject to this part.62 FR 13464, Mar. 20, 1997, as amended at 69FR 71655, Dec. 9, 2004Sec. Implementation.(a) For records required to be maintained but如果符合本条款的要求，人们可以使用not submitted to the agency, persons may use全部或部分电子记录代替纸制记录或用electronic

11、 records in lieu of paper records or电子签名代替传统签名。electronic signatures in lieu of traditional(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:signatures, 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 r

12、ecords in lieu ofpaper records or electronic signatures in lieuof traditionalsignatures, in whole or inpart, 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 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(2) The document or parts of

13、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.through of this chapter. Records thatsatisfy the requirements of part 1, subpart JFDA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

14、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。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

15、unit(s) ., specific center, office, division, branch) to which such submissions maybe 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 offici

16、al and must accompany any electronic records.Persons are expected to consult with the intended agency receiving unit for details on how ., method of transmission, media, fileformats, and technical protocols) and whetherto proceed with the electronic submission.定义Sec. Definitions.(a)包含于法案201部分中术语的定义

17、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(21 321-393 )(2) 机构是指美国食品和药品管理局(a) The 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

18、the Federal Food, Drug, and Cosmetic Act (secs. 201-903 (21 321-393).(2) Agency means the Food and Drug(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。Administration.(3) Biometrics means a method of verifying an individual's

19、 identity based on measurement of the individual's 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 environment in which system access is controlled by persons who are responsible for the

20、content ofelectronic 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参数计算以使签名者的身份和数据的完 originator authentication, computed by using整性能被校验。a set of rules and a set of parameters such that the identi

21、ty of the signer and the integrityof the data can be verified.(6) Electronic record meansany combination oftext, graphics, data, audio, pictorial, orarchived, retrieved, or distributed by a computer system.(7) Electronic signature meansa computer data compilation of any symbol or series of symbols e

22、xecuted, adopted, or authorized by an individual to be the legally binding(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other information representation in digitalf

23、orm that is created, modified, maintained,所采纳的个人签名或合法标志equivalent of the individual's handwritten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。signature.(8) Handwritten signature means the scripted name or legal ma

24、rk 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 appl

25、ied to paper, mayalso be applied to other devices that capturethe name or mark.分章B电子记录(9) Open system meansan environment in which system access is not controlled by persons who are responsible for the content of electronic records that are on the system.Subpart B-Electronic Records封闭系统的管理Sec. Contr

26、ols 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：Persons who use closed systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrit

27、y, and, when appropriate, the confidentiality of electronic records, and to ensure that the signer cannot readily(a) 系统的验证以保证准确、可靠、稳 repudiate the signed record as not genuine.(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、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)

28、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叱地预期性目匕，有目匕力识别无效的和被Such procedures and controls shall include thefollowing:改变的记录。(a) Validation of systems to ensure accuracy, reliability,consistentintendedperformanc

29、e, and the ability to discern invalid or altered records.(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 th

30、e ability of the agency to perform such review and copying of the electronic records.(c) 记录的保护以使记录能够在整个 Protection of records to enable theiraccurate and ready retrieval throughout therecords retention period.(d) Limiting system access to authorized individuals.(e) Use of secure, computer-generated,

31、 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 t

32、hat的。 必要时，使用操作系统检查以加强进程和事件的排序。required for the subject electronic records and shall be available for agency review and copying.(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。(h)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。 Use of operational system checks to enforce permitted sequenc

33、ing of steps and events, as appropriate.(g) Use of authority checks to ensure that only authorized individuals can use the system, electronicallysign a record, access theoperation or computer system input or output device, altera record, or performtheoperation at hand.(h) Use of device ., terminal)

34、checks to determine, as appropriate, the validity of the source of data input or operational(i)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)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) 在系统文件方面运用适当的控制 包括：1)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instruction.(i) Determination that persons who develop

35、, maintain, or use electronic record/electronic signature systems have the education, training, and experience to perform their assigned tasks.(j) The establishment of, and adherence to, written policies that hold individuals accountable and responsible for actions initiated under their electronic s

36、ignatures, in order to deter record and signature falsification.制。2）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。(k) Use of appropriate controls over systems documentation including:(l) Adequate controls over the distribution of, access to, and use of documentation for system operation and maintenance.(2) R

37、evision and change control procedures to maintain an audit trail that documents time-sequenced development and modification of systems documentation.开放系统的管理Sec. Controls for open systems.人们使用开放系统来建立、修改、保持、或传送电子记录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。这种程序和控制应包括那些在中被 识别的，必要时，附加的测量例如文档 的加密术和运用适

38、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。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 c

39、reation to the point of their receipt.Such procedures and controls shall include those identified in , 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

40、, and confidentiality.签名的显示Sec. Signature manifestations.(a) 签署电子记录应包含能清晰显示如下所有与签名相关的信息：1)用印刷体书写出签名者的名字2)签名生效的日期和时间；和3)和签名相关的含意(例如回顾、批 准、职责、或原创作者)(b) 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 们易读的电子记录的形式(例如电子显 示或打印输出)。(a) Signed electronic records shall contain information associated

41、 with the signing that clearly indicates all of the following:(1) The printed name of the signer;(2) The date and time when the signature was executed; and(3) The meaning (such as review, approval, responsibility, or authorship) associated with the signature.(b) The items identified in paragraphs (a

42、)(1), (a)(2), and (a)(3) of this section shall be subject to the samecontrols 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).签名/记录连接Sec. Signature/record linking.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

43、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。分章C电子签名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 electronic record by

44、 ordinary means.Subpart C-Electronic Signatures般要求Sec. General requirements.(a)每一电子签名应是唯一对应单独/、匚 ,.,. .(a) 七)uqu心由 八ju千g(a) Each electronic signature shall be unique个人的并且不目匕被再使用、或再分配to one individual and shall not be reused by,给其他任何人(b) 在一个组织建立，分配，证明，或 批准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。签名者使用电

45、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)证明要以书面形式提交到“地方运 转办公室"(HFC-100, 5600 FishersLane, Rockville, MD 20857 )并采 用传统的手写签名。2)应FDA要求，人们在使用电子签名 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。or reassigned to, anyone else.(b) Before an organization establishes, assigns, certifi

46、es, or otherwise sanctions an individual's electronic signature, or any element of such electronic signature, the organization shall verify the identity of the individual.(c) Persons using electronic signatures shall, prior to or at the time of such use, certify to the agency that the electronic

47、 signatures in their system, used on or after August 20, 1997, are intended to be the legally binding equivalent of traditional handwritten signatures.(1) The certification shall be submitted in paper form and signed with a traditional handwritten signature, to the Office of Regional Operations (HFC

48、-100), 5600 Fishers Lane, Rockville, MD 20857.(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 signer's handwritten signature.电子签名的成分及管理Sec. Electronic s

49、ignature components andcontrols.(a) 不依据生物测定学的电子签名应:1)使用至少二种截然不同的证明成 分，例如识别码和密码。i) 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) 当一个人不在一个独立的持续受 控的系统登录期间内签署一个或多个签(a) Electronic signatures that are not basedupon biometrics shall:(1) Employ

50、at least two distinct identification components such as an identification code and password.(i) When an individual executes a series of signings during a single, continuous period of controlled system access, the first signing shallbeexecutedusingallelectronicsignature components; subsequent signing

51、s shallbeexecutedusingatleast oneelectronic signature component that is only executable by, and designed to be used only by,名时，每一个被签署的签名应使用所有the individual.的电子签名成分(ii) When an individual executes one or moresignings not performed during a single, continuous period of controlled system access, each s

52、igning shall be executed using all of the electronic signature components.2)仅被他们真正的所有者使用；和3)管理和签署以确保任何除其真正所 有者外的其他人尝试使用该电子签 名时需要二个或更多的人的协作。(b) 依据生物测定学的电子签名应被 设计成能确保他们不能被真正所有者之(2) Be used only by their genuine owners; and(3) Be administered and executed to ensure that attempted use of an individual&#

53、39;s electronic signature by anyone other than its genuine owner requires collaboration of two or more individuals.(b) Electronic signatures based upon外的其他人使用biometrics shall be designed to ensure that识别代码和密码的管理they cannot be used by anyone other than their genuine owners.Sec. Controls for identificationcodes/passwords.人们使用基于利用识别码和密码混 合的电子签名应使用管理以保证他们的 安全和完整，这种管理应包括：(a) 保持每一的识别码和密码结合的