Guidance for Industry Part 11 Electronic Records Electronic SignaturesAugust 2003 Page 1 of 13 Guidance for Industry Part 11 Electronic Records Electronic Signatures Scope andApplication August 2003 Pharmaceutical CGMPs FDA 工业指南工业指南 联邦法规联邦法规 11 部分部分 电子记录和电子签名电子记录和电子签名 范围和应用范围和应用 2003 年 8 月 药物 CGMPs TABLE OF CONTENTS目录目录 I Introduction 2 II Background 3 III Discussion 5 A OverallApproach to Part 11 Requirements 5 B Details ofApproach Scope of Part 11 6 1 Narrow Interpretation of Scope 6 2 Definition of Part 11 Records 7 C Approach to Specific Part 11 Requirements 9 1 Validation 9 2 Audit Trail 9 3 Legacy Systems 10 4 Copies of Records 11 5 Record Retention 12 IV REFERENCES 13 Guidance for Industry Part 11 Electronic Records Electronic SignaturesAugust 2003 Page 2 of 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 FDAor 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 Introduction This guidance is intended to describe the Food and Drug Administration s FDA s current thinking regarding the scope and application of part 11 of Title 21 of the Code of Federal Regulations Electronic Records Electronic Signatures 21 CFR Part 11 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 part 11 Part 11 applies to records in electronic form that are created modified maintained archived retrieved or transmitted under any records requirements set forth in Agency regulations Part 11 also applies to electronic records submitted to the Agency under the Federal Food Drug and Cosmetic Act theAct and the Public Health Service Act the PHSAct even if such records are not specifically identified inAgency regulations 11 1 The underlying requirements set forth in theAct PHSAct and FDA regulations other than part 11 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 FDAis re examining part 11 as it applies to all FDAregulated products We anticipate initiating rulemaking to change part 11 as 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 您 还可以选择使用另一种符合要求和法规的替代方 法 对替代方法有任何问题 请与负责实施本指南 的相关人员联系 如果您无法确认联系人 可拨打 本指南首页中相应的电话号码咨询 1 介绍介绍 该指南旨在给出 FDA21 CFR 第 11 条 电子记录 电子签名的当前思路 为了遵守法规或 FDA 规定来保存记录或递交文件 至 FDA 该指南为选择保存记录或电子递交指定文 件需要遵守第 11 条款提供了指导 第 11 条款适用于在 FDA 提出的法规要求前提下 以电子表格形式建立 修改 维护 归档 检索或 传送记录 本条款也同样适用于 联邦食品 药品 和化妆品法案 和 公众健康服务法案 项下递交 电子记录至官方 即使该类记录在 FDA 法规中没有 明确规定 11 1 预定法规 指的是在法案 联邦 食品 药品和化妆品法案 PHS 法案 公众健 康服务法案 和 FDA 法规 第 11 条款除外 中提 到的要求 随着人用 动物用药物和生物制剂 CGMP 意识的发 展 FDA 重新审核了第 11 条款因其适用于 FDA 监 管的所有产品 通过复核 FDA 将启动立法来修改 第 11 条款 该指南详细解释了第 11 条款的适用范 围 第 11 条款的审核还在进行中 对于第 11 条款 中的某些要求 FDA 打算采取自由裁量权 即正如 Guidance for Industry Part 11 Electronic Records Electronic SignaturesAugust 2003 Page 3 of 13 will narrowly interpret the scope of part 11 While the re examination of part 11 is under way we intend to exercise enforcement discretion with respect to certain part 11 requirements That is we do not intend to take enforcement action to enforce compliance with the validation audit trail record retention and record copying requirements of part 11 as explained in this guidance However records must still be maintained or submitted in accordance with the underlying predicate rules and theAgency can take regulatory action for noncompliance with such predicate rules In addition we intend to exercise enforcement discretion and do not intend to take or recommend action to enforce any part 11 requirements with regard to systems that were operational before August 20 1997 the effective date of part 11 commonly known as legacy systems under the circumstances described in section III C of this guidance Note that part 11 remains in effect and that this exercise of enforcement discretion applies only as identified in this guidance FDA s guidance documents including this guidance do not establish legally enforceable responsibilities Instead guidances describe theAgency s current thinking on a topic and should be viewed only as recommendations unless specific regulatory or statutory requirements are cited The use of the word should inAgency guidances means that something is suggested or recommended but not required II Background In March of 1997 FDA issued final part 11 regulations that p