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21 CFR 11.1~11.3

更新时间:2017-08-18

21 CFR 11.1 范围 20160527

§11.1   Scope. 范围

(a) The regulations in this part set forth thecriteria under which the agency considers electronic records, electronicsignatures, and handwritten signatures executed to electronic records to betrustworthy, reliable, and generally equivalent to paper records andhandwritten 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 formthat are created, modified, maintained, archived, retrieved, or transmitted,under any records requirements set forth in agency regulations. This part alsoapplies to electronic records submitted to the agency under requirements of theFederal Food, Drug, and Cosmetic Act and the Public Health Service Act, even ifsuch records are not specifically identified in agency regulations. However,this part does not apply to paper records that are, or have been, transmittedby 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) Whereelectronic signatures and their associated electronic records meet the requirementsof this part, the agency will consider the electronic signatures to beequivalent to full handwritten signatures, initials, and other general signingsas required by agency regulations, unless specifically excepted byregulation(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签名、首字母签名、和其他的FDA法规所求的一般签名,1997820日之后生效的法规明确排除者除外。

 

(d) Electronic records that meet the requirements ofthis 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) Computersystems (including hardware and software), controls, and attendantdocumentation maintained under this part shall be readily available for, andsubject 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 beestablished or maintained by §§1.326 through 1.368 of this chapter. Recordsthat satisfy the requirements of part 1, subpart J of this chapter, but thatalso 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§§1.368要求而建立或维护的记录。本章§§1.326§§1.368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 partdoes not apply to electronic signatures obtained under §101.11(d) of thischapter.

本部分不适用于依本章§101.11(d)所获得的电子签名。

 

(h) This part does not apply to electronic signaturesobtained 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 beestablished or maintained by part 117 of this chapter. Records that satisfy therequirements of part 117 of this chapter, but that also are required underother applicable statutory provisions or regulations, remain subject to thispart.

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 beestablished or maintained by part 507 of this chapter. Records that satisfy therequirements of part 507 of this chapter, but that also are required underother applicable statutory provisions or regulations, remain subject to thispart.

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 beestablished or maintained by part 112 of this chapter. Records that satisfy therequirements of part 112 of this chapter, but that also are required underother applicable statutory provisions or regulations, remain subject to thispart.

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 beestablished or maintained by subpart L of part 1 of this chapter. Records thatsatisfy the requirements of subpart L of part 1 of this chapter, but that alsoare required under other applicable statutory provisions or regulations, remainsubject 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 beestablished or maintained by subpart M of part 1 of this chapter. Records thatsatisfy the requirements of subpart M of part 1 of this chapter, but that alsoare required under other applicable statutory provisions or regulations, remainsubject 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 beestablished or maintained by subpart O of part 1 of this chapter. Records thatsatisfy the requirements of subpart O of part 1 of this chapter, but that alsoare required under other applicable statutory provisions or regulations, remainsubject 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 beestablished or maintained by part 121 of this chapter. Records that satisfy therequirements of part 121 of this chapter, but that also are required underother applicable statutory provisions or regulations, remain subject to thispart.

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。

 

[62 FR 13464, Mar. 20, 1997, as amended at 69 FR71655, Dec. 9, 2004; 79 FR 71253, 71291, Dec. 1, 2014; 80 FR 71253, June 19,2015; 80 FR 56144, 56336, Sept. 17, 2015; 80 FR 74352, 74547, 74667, Nov. 27,2015; 81 FR 20170, Apr. 6, 2016; 81 FR 34218, May 27, 2016]

【最后修订时间 2016527日】

 

21 CFR 11.2 Implementation.实施

§11.2   Implementation.实施

(a) For records required to be maintained but notsubmitted to the agency, persons may use electronic records in lieu of paperrecords or electronic signatures in lieu of traditional signatures, in whole orin 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 mayuse electronic records in lieu of paper records or electronic signatures inlieu 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 besubmitted have been identified in public docket No. 92S-0251 as being the typeof submission the agency accepts in electronic form. This docket will identifyspecifically what types of documents or parts of documents are acceptable forsubmission in electronic form without paper records and the agency receivingunit(s) (e.g., specific center, office, division, branch) to which suchsubmissions may be made. Documents to agency receiving unit(s) not specified inthe public docket will not be considered as official if they are submitted inelectronic form; paper forms of such documents will be considered as officialand must accompany any electronic records. Persons are expected to consult withthe intended agency receiving unit for details on how (e.g., method oftransmission, media, file formats, and technical protocols) and whether toproceed 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。

 

21 CFR 11.3 Definitions.定义

 

§11.3   Definitions.定义

(a) The definitions and interpretations of termscontained in section 201 of the act apply to those terms when used in thispart.

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 tothis 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 anindividual's identity based on measurement of the individual's physicalfeature(s) or repeatable action(s) where those features and/or actions are bothunique 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 systemaccess is controlled by persons who are responsible for the content ofelectronic 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 basedupon cryptographic methods of originator authentication, computed by using aset of rules and a set of parameters such that the identity of the signer andthe 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 indigital form that is created, modified, maintained, archived, retrieved, ordistributed 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、检索或分发。

 

(7) Electronic signature means a computer datacompilation of any symbol or series of symbols executed, adopted, or izedby an individual to be the legally binding equivalent of the individual's handwrittensignature.

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) Handwrittensignature means the scripted name or legal mark of an individual handwritten bythat individual and executed or adopted with the present intention toauthenticate a writing in a permanent form. The act of signing with a writingor marking instrument such as a pen or stylus is preserved. The scripted nameor legal mark, while conventionally applied to paper, may also be applied toother 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 systemmeans an environment in which system access is not controlled by persons whoare 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。

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