联邦法规：21CFR Part11“电子数据,电子签名,审计追踪” 中英对照(完整资料).doc

21CFR11-电子记录及电子签名Title 21 → Chapter I→ Subchapter A →Part11TITLE 21—Food and Drugs食品和药品CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTHAND HUMAN SERVICES 食品药品管理局，卫生福利部SUBCHAPTER A—GENERAL通则PART 11—ELECTRONIC 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 electronicrecords, 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。

最新21CFRPART11企业指南中英对照Guidance for IndustryPart11,Electronic Records;Electronic Signatures —Scope and ApplicationAugust2003Pharmaceutical CGMPsFDA工业指南联邦法规11部分电子记录和电子签名—范围和应用2003年8月药物CGMPsTABLE OF CONTENTS目录I.Introduction (2)II.Background (3)III.Discussion (5)A.Overall Approach to Part11Requirements (5)B.Details of Approach-Scope of Part11 (6)1.Narrow Interpretation of Scope (6)2.Definition of Part11Records (7)C.Approach to Specific Part11Requirements (9)1.Validation (9)2.Audit Trail (9)3.Legacy Systems (10)4.Copies of Records (11)5.Record Retention (12)IV.REFERENCES (13)This guidance represents the Food and Drug Administration's(FDA's)current thinking on this topic.It does not create or confer any rights for or on any person and does notoperate to bind FDA or the public.You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.If you want to discuss an alternative approach,contact the FDA staff responsible for implementing this guidance.If you cannot identify the appropriate FDA staff,call the appropriate number listed on the title page of this guidance.I.IntroductionThis guidance is intended to describe the Food and Drug Administration's(FDA’s)current thinking regarding the scope and application of part11of Title 21of the Code of Federal Regulations;Electronic Records;Electronic Signatures(21CFR Part11).This document provides guidance to persons who,in fulfillment of a requirement in a statute or another part of FDA's regulations to maintain records or submit information to FDA,have chosen to maintain the records or submit designated information electronically and,as a result,have become subject to part11.Part11applies to records in electronic form that are created,modified,maintained,archived, retrieved,or transmitted under any records requirements set forth in Agency regulations.Part11 also applies to electronic records submitted to the Agency under the Federal Food,Drug,and Cosmetic Act(the Act)and the Public Health Service Act(the PHS Act),even if such records are not specifically identified in Agency regulations(§11.1).The underlying requirements set forth in the Act,PHS Act, and FDA regulations(other than part11)are referred to in this guidance document as predicate rules.As an outgrowth of its current good manufacturing practice(CGMP)initiative for human and animal drugs andbiologics,FDA is re-examining part11as it applies to all FDA regulated products.We anticipate initiating rulemaking to change part11as a result of that re-examination.This guidance explains that we 本指南代表了FDA在此领域的当前思路，它不赋予任何人任何权利，也并非用于约束FDA或公众。

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。

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.(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.本条款的规那么提供了标准，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规那么中说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。

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。

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。

什么是21 CFR Part 11？21 CFR Part 11 联邦法规21章第11款主要规定内容涉及电子记录和电子签名编辑本段适用范围(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。

编辑本段履行(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(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；这种文件的书面形式将被认为是正式的但必须伴有电子记录。

Title 21 → Chapter I→ Subchapter A →Part11TITLE 21—Food and Drugs食品和药品CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTHAND HUMAN SERVICES 食品药品管理局，卫生福利部SUBCHAPTER A—GENERAL通则PART 11—ELECTRONIC 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 electronicrecords, 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。

Guidance for IndustryPart11,Electronic Records;Electronic Signatures —Scope and ApplicationAugust2003Pharmaceutical CGMPsFDA工业指南联邦法规11部分电子记录和电子签名—范围和应用2003年8月药物CGMPsTABLE OF CONTENTS目录I.Introduction (2)II.Background (3)III.Discussion (5)A.Overall Approach to Part11Requirements (5)B.Details of Approach-Scope of Part11 (6)1.Narrow Interpretation of Scope (6)2.Definition of Part11Records (7)C.Approach to Specific Part11Requirements (9)1.Validation (9)2.Audit Trail (9)3.Legacy Systems (10)4.Copies of Records (11)5.Record Retention (12)IV.REFERENCES (13)This guidance represents the Food and Drug Administration's(FDA's)current thinking on this topic.It does not create or confer any rights for or on any person and does not operate to bind FDA or the public.You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.If you want to discuss an alternative approach,contact the FDA staff responsible for implementing this guidance.If you cannot identify the appropriate FDA staff,call the appropriate number listed on the title page of this guidance.I.IntroductionThis guidance is intended to describe the Food and Drug Administration's(FDA’s)current thinking regarding the scope and application of part11of Title 21of the Code of Federal Regulations;Electronic Records;Electronic Signatures(21CFR Part11).This document provides guidance to persons who,in fulfillment of a requirement in a statute or another part of FDA's regulations to maintain records or submit information to FDA,have chosen to maintain the records or submit designated information electronically and,as a result,have become subject to part11.Part11applies to records in electronic form that are created,modified,maintained,archived, retrieved,or transmitted under any records requirements set forth in Agency regulations.Part11 also applies to electronic records submitted to the Agency under the Federal Food,Drug,and Cosmetic Act(the Act)and the Public Health Service Act(the PHS Act),even if such records are not specifically identified in Agency regulations(§11.1).The underlying requirements set forth in the Act,PHS Act, and FDA regulations(other than part11)are referred to in this guidance document as predicate rules.As an outgrowth of its current good manufacturing practice(CGMP)initiative for human and animal drugs and biologics,FDA is re-examining part11as it applies to all FDA regulated products.We anticipate initiating rulemaking to change part11as a result of that re-examination.This guidance explains that we 本指南代表了FDA在此领域的当前思路，它不赋予任何人任何权利，也并非用于约束FDA或公众。