Guidance for Industry Part 11, Electronic Records; Electronic Signatures August 2003
Guidance for Industry Part 11, Electronic Records; Electronic Signatures — Scope and Application August 2003 Pharmaceutical CGMPs FDA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CGMPs TABLE OF CONTENTS 目录 I. Introduction ....................................................................................................................................................... 2 II. Background ...................................................................................................................................................... 3 III. Discussion ......................................................................................................................................................... 5 A. Overall Approach to Part 11 Requirements ................................................................................................ 5 B. Details of Approach - 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 Page 1 of 13
Guidance for Industry Part 11, Electronic Records; Electronic Signatures August 2003
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. 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 (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 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, FDA is re-examining part 11 as it applies to all FDA regulated 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 该指南旨在给出FDA 21 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 Page 2 of 13
Guidance for Industry Part 11, Electronic Records; Electronic Signatures August 2003
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 the Agency 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 the Agency'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 in Agency guidances means that something is suggested or recommended, but not required. II. Background In March of 1997, FDA issued final part 11 regulations that provide criteria for acceptance by FDA, under certain circumstances, of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures executed on paper. These regulations, which apply to all FDA program areas, were intended to permit the widest possible use of electronic technology, compatible with FDA's responsibility to protect the public health. 本指南中所说，FDA并不强制要符合第11条款中关于验证、审计追踪、记录保留和记录复制的要求。但是，记录的保存或递交必须符合预定法规，对于不符合预定法规的记录，FDA会采取管制行动。 除此之外，FDA会采取自由裁量权，但不会强制或建议1997年8月20日（第11条款的生效日期）之前的系统执行第11条款中的要求，针对此类情况（通常称为遗留系统）见本指南III.C部分。 请注意第11条款仍然有效，自由裁量权仅适用于本指南中提到的。 FDA的指南文件，包括本指南不具有法律效力。相反，指南代表FDA对某一领域的当前思路，仅作为建议，除非明确规定或法律要求。FDA指南中提到的should一词的意思是建议或推荐，不代表强制执行。 II.背景 1997年3月，FDA颁布了联邦法规第11条款，条款指出特定条件下，电子记录、电子签名及电子记录手写签名和纸质记录、纸质文件手写签名同等有效。此规定适用于FDA所有领域，旨在允许电子技术的广泛运用，和FDA的职责相符，旨在保护公众健康。 Page 3 of 13
Guidance for Industry Part 11, Electronic Records; Electronic Signatures August 2003
After part 11 became effective in August 1997, significant discussions ensued among industry, contractors, and the Agency concerning the interpretation and implementation of the regulations. FDA has (1) spoken about part 11 at many conferences and met numerous times with an industry coalition and other interested parties in an effort to hear more about potential part 11 issues; (2) published a compliance policy guide, CPG 7153.17: Enforcement Policy: 21 CFR Part 11; Electronic Records; Electronic Signatures; and (3) published numerous draft guidance documents including the following: ? 21 CFR Part 11; Electronic Records; Electronic Signatures, Validation ? 21 CFR Part 11; Electronic Records; Electronic Signatures, Glossary of Terms ? 21 CFR Part 11; Electronic Records; Electronic Signatures, Time Stamps ? 21 CFR Part 11; Electronic Records; Electronic Signatures, Maintenance of Electronic Records ? 21 CFR Part 11; Electronic Records; Electronic Signatures, Electronic Copies of Electronic Records Throughout all of these communications, concerns have been raised that some interpretations of the part 11 requirements would (1) unnecessarily restrict the use of electronic technology in a manner that is inconsistent with FDA's stated intent in issuing the rule, (2) significantly increase the costs of compliance to an extent that was not contemplated at the time the rule was drafted, and (3) discourage innovation and technological advances without providing a significant public health benefit. These concerns have been raised particularly in the areas of part 11 requirements for validation, audit trails, record retention, record copying, and legacy systems. As a result of these concerns, we decided to review the part 11 documents and related issues, particularly in light of the Agency's CGMP initiative. In the Federal Register of February 4, 2003 (68 FR 5645), we announced the withdrawal of the draft guidance for industry, 21 CFR Part 11; Electronic Records; 1997年8月，第11条款生效后，关于对该条款的解释和执行，企业、生产商和FDA对此展开了激烈讨论。FDA在数次会议中提到过第11条款，在产业联盟和相关团体中聆听更多的有关第11条款的潜在问题；同时FDA发布了政策指南(CPG)：CPG 7153.17：强制执行政策，21 CFR第11条款，电子记录、电子签名；另外FDA还发布了很多个指南草案，包括： ? 21 CFR 第11条款：电子记录、电子签名-验证 ? 21 CFR 第11条款：电子记录、电子签名-术语 ? 21 CFR 第11条款：电子记录、电子签名-时间轴 ? 21 CFR 第11条款：电子记录、电子签名-电子记录维护 ? 21 CFR 第11条款：电子记录、电子签名-电子记录的备份 经过多次讨论，对第11条款的解读主要关注的问题有以下几点：（1）不必要的限制使用电子技术，这与FDA颁布该法规的意图不相符；（2）在一定程度上明显增加了成本，这与当初起草该法规的意图不符；（3）阻碍创新和技术进步，公众健康并未获得明显收益。这些问题在第11条款的验证、审计追踪、记录保留、记录复印和遗留系统领域显得更为突出。 针对这些问题，我们决定审核第11条款和相关问题，尤其会从FDA的CGMP角度出发。2003年2月4日，在联邦公报（68 FR 5645）中我们宣布撤销工业指南草案：21 CFR第11条款：电子记录、电子签名和电子记录的拷贝。当该指南草案可能不再体现CGMP条件下FDA的方针政策，FDA会尽 Page 4 of 13
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