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【最新整理，下载后即可编辑】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 electronic 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, 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。
21 CFR Part 11 LIMS Requirements Electronic signatures and records21 CFR Part 11 中关于LIMS对电子签名和记录的要求1. Electronic Signatures电子签名UR-1: Electronic signatures must be unique to each individual. Each user must have a unique Full Name. Each user must have a unique user id.UR-1: 电子签名必须对每个人都是独一无二的。
每个用户必须有一个惟一的全名。
每个用户必须拥有唯一的用户ID。
UR-2: The system must verify that an individual has the authority to electronically sign a record before allowing them to do so.UR-2: 该系统必须验证一个人在允许他们这样做之前，有权以电子方式签署记录。
UR-3: The system will not allow electronic signatures to be reused or reassigned to anyone other than the original owner.UR-3: 该系统将不允许电子签名被重新使用或重新分配给除原所有者以外的任何人。
UR-4: The meaning of the signature (author, reviewer, or approver) must be displayedUR-4: 必须显示签名的含义（作者、审稿人或审批人）a. at the point of signing;a. 在签字的时候b. on the human readable copy of the associated record (screen or printed);b. 在人类可读的相关记录副本(屏幕或打印)c. on the electronic copy of the associated record.c. 在相关记录的电子副本上UR-5: Maintain electronic records and linked signatures for the life of the electronic record.UR-5: 在电子记录的生命周期内维护电子记录和连接的签名UR-6: Electronic signature shall be able to show the signer’s full printed name, to show the time and date of execution.UR-6: 电子签名应能显示签名者的全名，并显示执行时间和日期。
精品文档[Code of Federal Regulations] ] [联邦法规[Title 21, Volume 1] ]卷第21章第1[[Revised as of April 1, 2006] ] 日修改月01年[200604[CITE:21CFR 11]21CFR 11] [代号：TITLE 21--Food And Drugs章－食品与药品第21CHAPTER I--Food And Drug Administration节－食品和药品管理局第1Department of Health And Human Services 健康与人类服务部Subchapter A--General 亚节－一般规定PART 11 Electronic Records;Electronic电子记录；电子签名第11款SignaturesSubpart A--General ProvisionsA 一般规定分章Sec. 11.1 Scope.11.1适用范围the forth this part set in (a) 本条款的规则提供了标准，在此标准(a) The regulationsconsidersagency under which the criteria 将认为电子记录、电子签名、FDA之下and signatures, electronic records, electronic 和在电子记录上的手签名是可信赖的、electronicto handwritten signatures executed 可靠的并且通常等同于纸制记录和在纸records to be trustworthy, reliable, and generally上的手写签名。
handwrittenand to paper records equivalentsignatures executed on paper.(b) This part applies to records in electronic form 规则中阐明的本条款适用于在FDA(b) that are created, modified, maintained, archived, 在任何记录的要求下，以电子表格形式recordsany transmitted, under retrieved, or 建立、修改、维护、归档、检索或传送requirements set forth in agency regulations. 的记录。
制药行业美国FDA法规联邦法规21章第11款电子记录；电子签名分章A 一般规定11.1适用范围11.2 履行11.3 定义分章B 电子记录11.10 封闭系统的控制11.30 开放系统的控制11.50 签名的验证11.70 签名/记录连接分章C 电子签名11.100 一般要求11.200 电子签名的构成及控制11.300 识别代码和密码的控制分章A 一般规定11.1适用范围(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。
(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。
11.2履行(a) 需要维护，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：(1) 符合条款的要求；和(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。
[Code of Federal Regulations] [联邦法规][Title 21, Volume 1] [ 第21章第1 卷][Revised as of April 1, 2006] [2006 年04月01日修改][CITE: 21CFR 11] [ 代号：21CFR 11]TITLE 21--Food And Drugs 第21 章－食品与药品CHAPTERI--Food And DrugAdministration第1 节－食品和药品管理局Department of Health And HumanServices健康与人类服务部Subchapter A--General亚节－一般规定第11 款电子记录；电子签名PART 11 Electronic Records; ElectronicSignaturesSubpart A--General Provisions 分章A 一般规定Sec. 11.1 Scope.11.1 适用范围(a) 本条款的规则提供了标准，在此标准(a) The regulations in this part set forth thecriteria under which the agency considers 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e lectronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy,上的手写签名。
reliable, and generally equivalent to paperrecords and handwritten signatures executedon paper.(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。
[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 Regulations][Title 21, Volume 1][Revised as of April 1, 2006][CITE: 21CFR 11]TITLE 21--Food And DrugsCHAPTER I--Food And Drug Administration Department of Health And Human Services Subchapter A--General第11款电子记录；电子签名PART 11 Electronic Records; ElectronicSignatures分章A 一般规定11.1适用范围Subpart A--General Provisions Sec. 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 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 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.(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.(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。
[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 Regulations][Title 21, Volume 1][Revised as of April 1, 2006][CITE: 21CFR 11]TITLE 21--Food And DrugsCHAPTER I--Food And Drug Administration Department of Health And Human Services Subchapter A--General第11款电子记录；电子签名PART 11 Electronic Records; Electronic Signatures分章A 一般规定适用范围Subpart A--General Provisions Sec. Scope.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。
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 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 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.(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.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。
[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 Regulations][Title 21, Volume 1][Revised as of April 1, 2006][CITE: 21CFR 11]TITLE 21--Food And DrugsCHAPTER I--Food And Drug Administration Department of Health And Human Services Subchapter A--General第11款电子记录；电子签名PART 11 Electronic Records; ElectronicSignatures分章A 一般规定11.1适用范围Subpart A--General Provisions Sec. 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 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 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.(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.(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) 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 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.[62 FR 13464, Mar. 20, 1997, as amended at 69 FR 71655, Dec. 9, 2004]11.2履行Sec. 11.2 Implementation.(a) 需要维护，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 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 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(1) The requirements of this part are met; and(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的书面形式将被认为是正式的但必须伴有电子记录。
