最新 21 CFR Part 11 企业指南- 中英对照 - 图文

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

Guidance for Industry Part 11, Electronic Records; Electronic Signatures August 2003

Electronic Signatures, Electronic Copies of Electronic Records. We had decided we wanted to minimize industry time spent reviewing and commenting on the draft guidance when that draft guidance may no longer represent our approach under the CGMP initiative. Then, in the Federal Register of February 25, 2003 (68 FR 8775), we announced the withdrawal of the part 11 draft guidance documents on validation, glossary of terms, time stamps, maintenance of electronic records, and CPG 7153.17. We received valuable public comments on these draft guidances, and we plan to use that information to help with future decision-making with respect to part 11. We do not intend to re-issue these draft guidance documents or the CPG. We are now re-examining part 11, and we anticipate initiating rulemaking to revise provisions of that regulation. To avoid unnecessary resource expenditures to comply with part 11 requirements, we are issuing this guidance to describe how we intend to exercise enforcement discretion with regard to certain part 11 requirements during the re-examination of part 11. As mentioned previously, part 11 remains in effect during this re-examination period. III. Discussion A. Overall Approach to Part 11 Requirements As described in more detail below, the approach outlined in this guidance is based on three main elements: ? Part 11 will be interpreted narrowly; we are now clarifying that fewer records will be considered subject to part 11. ? For those records that remain subject to part 11, we intend to exercise enforcement discretion with regard to part 11 requirements for validation, audit trails, record retention, and record copying in the manner described in this guidance and with regard to all part 11 requirements for systems that were operational before the effective date of part 11 (also 可能减少行业对该草案的审核和评论时间。接着，在2003年2月25日联邦公报（68 FR 8775）中我们宣布撤销第11条款关于验证、术语、时间轴、电子记录维护和CPG 7153.17的指南文件。对于这些指南草案，我们收到了许多宝贵的意见，我们会用这些意见来帮助以后第11条款的建立。我们并不打算重新发布这些指南草案或CPG（政策指南）。 FDA正在重新审核第11条款，并期望通过立法来修订此法案中的规定。在重新审核的过程中，为了符合第11条款，避免不必要的资源浪费，FDA发布了这个指南，指出针对第11条款中的特定要求如何执行自由裁量权。正如之前所说，审核期间第11条款仍然有效。 III.讨论 A.第11条款概述 正如以下详述，该指南概括的方法基于以下3个方面： ? 对第11条款的详细解读，FDA明确了记录可以不遵守第11条款； ? 对于遵守第11条款的记录，就该指南中提出的与第11条款有关的验证、审计追踪、记录保留和记录复印及在第11条款的生效之前的系统（通常称为遗留系统），FDA会采取自由裁量权。 Page 5 of 13

Guidance for Industry Part 11, Electronic Records; Electronic Signatures August 2003

known as legacy systems). ? We will enforce all predicate rule requirements, including predicate rule record and recordkeeping requirements. It is important to note that FDA's exercise of enforcement discretion as described in this guidance is limited to specified part 11 requirements (setting aside legacy systems, as to which the extent of enforcement discretion, under certain circumstances, will be more broad). We intend to enforce all other provisions of part 11 including, but not limited to, certain controls for closed systems in § 11.10. For example, we intend to enforce provisions related to the following controls and requirements: ? limiting system access to authorized individuals ? use of operational system checks ? use of authority checks ? use of device checks ? determination that persons who develop, maintain, or use electronic systems have the education, training, and experience to perform their assigned tasks ? establishment of and adherence to written policies that hold individuals accountable for actions initiated under their electronic signatures ? appropriate controls over systems documentation ? controls for open systems corresponding to controls for closed systems bulleted above (§ 11.30) ? requirements related to electronic signatures (e.g., §§ 11.50, 11.70, 11.100, 11.200, and 11.300) We expect continued compliance with these provisions, and we will continue to enforce them. Furthermore, persons must comply with applicable predicate rules, and records that are required to be maintained or submitted must remain secure and reliable in accordance with the predicate rules. B. Details of Approach - Scope of Part 11 1. Narrow Interpretation of Scope We understand that there is some confusion about the ? FDA会强制执行所有的预定法规，包括预定记录和记录保存要求。 需要注意的是本指南提到的FDA执行自由裁量权仅限于第11条款中的特定要求（遗留系统除外，在特定情况下，遗留系统自由裁量权的范围更广）。FDA打算执行第11条款中的所有其他条款，包括但不限于条款中§ 11.10封闭系统的控制。例如，对以下控制和要求，FDA将执行条款中的规定。 ? 进入授权的限制系统 ? 使用操作系统检查 ? 使用授权检查 ? 使用设备检查 ? 确定研发、维护或使用电子系统的人员所需的学历、培训和经验 ? 发起电子签名，建立并遵守书面规定 ? 对系统文件的合理控制 ? 开放系统管理同上述封闭系统管理一致（§ 11.30） ? 电子签名相关要求（例如，§§ 11.50, 11.70, 11.100, 11.200, and 11.300） FDA期望符合这些规定，并会继续执行这些规定。此外，必须符合适用的预定法规，按照预定法规，记录必须维护、递交的记录必须可靠且长期保留。 B. 方法描述-第11条款适用范围 1.狭义适用范围 对第11条款的适用范围会有些费解，有人认为第 Page 6 of 13

Guidance for Industry Part 11, Electronic Records; Electronic Signatures August 2003

scope of part 11. Some have understood the scope of part 11 to be very broad. We believe that some of those broad interpretations could lead to unnecessary controls and costs and could discourage innovation and technological advances without providing added benefit to the public health. As a result, we want to clarify that the Agency intends to interpret the scope of part 11 narrowly. Under the narrow interpretation of the scope of part 11, with respect to records required to be maintained under predicate rules or submitted to FDA, when persons choose to use records in electronic format in place of paper format, part 11 would apply. On the other hand, when persons use computers to generate paper printouts of electronic records, and those paper records meet all the requirements of the applicable predicate rules and persons rely on the paper records to perform their regulated activities, FDA would generally not consider persons to be \records in lieu of paper records\§ 11.2(a) and 11.2(b). In these instances, the use of computer systems in the generation of paper records would not trigger part 11. 2. Definition of Part 11 Records Under this narrow interpretation, FDA considers part 11 to be applicable to the following records or signatures in electronic format (part 11 records or signatures): ? Records that are required to be maintained under predicate rule requirements and that are maintained in electronic format in place of paper format. On the other hand, records (and any associated signatures) that are not required to be retained under predicate rules, but that are nonetheless maintained in electronic format, are not part 11 records. We recommend that you determine, based on the predicate rules, whether specific records are part 11 records. We recommend that you document such decisions. 11条款的适用范围是相当宽泛的。FDA相信对这些宽泛范围的解释可能会导致不必要的控制和成本，还可能会阻碍创新和技术进步，对公众健康不会带来有利影响。因此，FDA需要澄清第11条款的狭义适用范围。 在狭义适用范围下，记录需在预定法规要求下保存或递交FDA，第11条款适用于当选择使用电子文件替代纸质文件时。另一方面，§§ 11.2(a)和11.2(b)指出，当使用计算机打印电子记录，且电子记录符合预定法规的所有要求，并依据纸质记录进行法规操作，FDA不会建议使用电子记录代替纸质记录。这种情况下，使用计算机系统打印纸质记录不会引发第11条款。 2.第11条款中记录的定义 狭义上讲，FDA认为第11条款适用于以下电子形式的记录或签名： ? 按照预定法规要求保存记录和用电子形式代替纸质形式保存记录。另一方面，预定法规未规定记录及相关签名需要保留，但仍以电子形似保存的则不是第11条款中提到记录。 FDA建议根据预定法规确定某些记录是否是第11条款中的记录，并记录结果。 Page 7 of 13

Guidance for Industry Part 11, Electronic Records; Electronic Signatures August 2003

? Records that are required to be maintained under predicate rules, that are maintained in electronic format in addition to paper format, and that are relied on to perform regulated activities. In some cases, actual business practices may dictate whether you are using electronic records instead of paper records under § 11.2(a). For example, if a record is required to be maintained under a predicate rule and you use a computer to generate a paper printout of the electronic records, but you nonetheless rely on the electronic record to perform regulated activities, the Agency may consider you to be using the electronic record instead of the paper record. That is, the Agency may take your business practices into account in determining whether part 11 applies. Accordingly, we recommend that, for each record required to be maintained under predicate rules, you determine in advance whether you plan to rely on the electronic record or paper record to perform regulated activities. We recommend that you document this decision (e.g., in a Standard Operating Procedure (SOP), or specification document). ? Records submitted to FDA, under predicate rules (even if such records are not specifically identified in Agency regulations) in electronic format (assuming the records have been identified in docket number 92S-0251 as the types of submissions the Agency accepts in electronic format). However, a record that is not itself submitted, but is used in generating a submission, is not a part 11 record unless it is otherwise required to be maintained under a predicate rule and it is maintained in electronic format. ? Electronic signatures that are intended to be the equivalent of handwritten signatures, initials, and other general signings required by predicate rules. Part 11 signatures include electronic signatures that are used, for example, to document the fact that ? 按照预定法规要求保存记录，除纸质形式外还有电子形式保存记录，且依据记录进行相关法规操作。 一些情况下，§ 11.2(a)指出实际商业惯例可能会指出是否使用电子记录代替纸质记录。例如，如果记录需要按照预定法规保存，并且使用计算机打印电子文件，但仍然依据电子记录进行法规操作时，FDA则会认为使用的是电子记录而非纸质记录。这就是说，FDA会综合考虑企业的商业惯例来决定是否适用第11条款。 同时，FDA建议每份记录需按照预定法规保存，企业要事先决定依据电子记录还是纸质记录进行相关法规操作。FDA建议以文件形式记录决定，如SOP或标准文件。 ? 按照预定法规以电子形式递交给FDA的文件（即使FDA法规中没有明确规定，假设给该电子文件分配了一个登记号：92S-0251），但是，如果文件本身不是用于递交，而是用于生成递交文件的，除非预定法规单独要求保存且以电子形式保存，那么该文件则不属于第11条款中的记录。 ? 电子签名等同于手写签名，缩写及预定法规中的通用符号。第11条款的签名包括使用的电子签名，如记录符合预定法规的特定事件，或发生的活动（如批准、审核、确认）。 Page 8 of 13

Guidance for Industry Part 11, Electronic Records; Electronic Signatures August 2003

certain events or actions occurred in accordance with the predicate rule (e.g. approved, reviewed, and verified). C. Approach to Specific Part 11 Requirements 1. Validation The Agency intends to exercise enforcement discretion regarding specific part 11 requirements for validation of computerized systems (§ 11.10(a) and corresponding requirements in § 11.30). Although persons must still comply with all applicable predicate rule requirements for validation (e.g., 21 CFR 820.70(i)), this guidance should not be read to impose any additional requirements for validation. We suggest that your decision to validate computerized systems, and the extent of the validation, take into account the impact the systems have on your ability to meet predicate rule requirements. You should also consider the impact those systems might have on the accuracy, reliability, integrity, availability, and authenticity of required records and signatures. Even if there is no predicate rule requirement to validate a system, in some instances it may still be important to validate the system. We recommend that you base your approach on a justified and documented risk assessment and a determination of the potential of the system to affect product quality and safety, and record integrity. For instance, validation would not be important for a word processor used only to generate SOPs. For further guidance on validation of computerized systems, see FDA’s guidance for industry and FDA staff General Principles of Software Validation and also industry guidance such as the GAMP 4 Guide (See References). 2. Audit Trail The Agency intends to exercise enforcement discretion regarding specific part 11 requirements related to C.第11条款特定要求的应对方法 1.验证 就第11条款中计算机系统验证（§ 11.10(a)和§ 11.30中的要求），FDA打算采取自由裁量权。尽管企业必须符合预定法规对验证的要求（如21 CFR 820.70(i)），对于验证来说，该指南则不再提出额外要求。 FDA建议计算机系统验证及其验证范围需考虑遵守预定法规对系统带来的影响。企业还要考虑受影响系统对记录和签名准确性、可靠性、完整性、有效性和真实性的影响。即使预定法规没有要求系统验证，在一些情况下系统验证仍然是重要的。 FDA建议基于方法依据合理的且记录的风险评估，确定系统对产品质量、安全和记录完整性的潜在影响。例如对于仅仅用于生成SOP的文本处理程序，验证就不重要了。 计算机系统验证指南详见FDA工业指南、FDA员工通用指南：软件验证，及工业指南，如GAMP 4指南（见参考文献）。 2.审计追踪 就第11条款中使用计算机产生的、标记时间的审计追踪（§ 11.10 (e), (k)(2)及§11.30），FDA打算采取 Page 9 of 13

Guidance for Industry Part 11, Electronic Records; Electronic Signatures August 2003

computer-generated, time-stamped audit trails (§ 11.10 (e), (k)(2) and any corresponding requirement in §11.30). Persons must still comply with all applicable predicate rule requirements related to documentation of, for example, date (e.g., § 58.130(e)), time, or sequencing of events, as well as any requirements for ensuring that changes to records do not obscure previous entries. Even if there are no predicate rule requirements to document, for example, date, time, or sequence of events in a particular instance, it may nonetheless be important to have audit trails or other physical, logical, or procedural security measures in place to ensure the trustworthiness and reliability of the records. We recommend that you base your decision on whether to apply audit trails, or other appropriate measures, on the need to comply with predicate rule requirements, a justified and documented risk assessment, and a determination of the potential effect on product quality and safety and record integrity. We suggest that you apply appropriate controls based on such an assessment. Audit trails can be particularly appropriate when users are expected to create, modify, or delete regulated records during normal operation. 3. Legacy Systems The Agency intends to exercise enforcement discretion with respect to all part 11 requirements for systems that otherwise were operational prior to August 20, 1997, the effective date of part 11, under the circumstances specified below. This means that the Agency does not intend to take enforcement action to enforce compliance with any part 11 requirements if all the following criteria are met for a specific system: ? The system was operational before the effective date. ? The system met all applicable predicate rule requirements before the effective date. ? The system currently meets all applicable predicate rule requirements. 自由裁量权。企业必须遵守预定法规中关于文件的所有要求，例如，日期（§ 58.130(e)）、时间、事件顺序和详细的变更记录不能掩盖之前的条目等。 即使预定法规对文件的日期、时间或事件顺序没有明确规定，审计追踪仍然是重要的，或采取安全管理程序保证记录的准确性和可靠性。FDA建议公司依据预定法规要求，及合理的且记录的风险评估，确定对产品质量、安全性和记录完整性的潜在影响，决定是否采用审计追踪或其他措施。FDA建议根据评估采取适当控制。日常操作中，当使用者创建、修改或删除规定的文件时，审计追踪显得尤为适用。 3.遗留系统（该指南中，遗留系统指的是在第11条款生效日期前已经执行的系统） 就第11条款中对1997年8月20日之前运行的系统，FDA打算采取自由裁量权。具体情况如下。 这就意味着如果系统满足以前所有要求，FDA则不强制执行第11条款中的要求。 ? 系统在生效日期（1997.08.20）之前执行 ? 系统符合生效日期前的所有预定法规要求 ? 系统现在符合所有预定法规要求 ? 企业有记录文件和合理依据证明系统符合预期用途（包括有文件记录安全性和完整性的可接受 Page 10 of 13

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? You have documented evidence and justification that the system is fit for its intended use (including having an acceptable level of record security and integrity, if applicable). If a system has been changed since August 20, 1997, and if the changes would prevent the system from meeting predicate rule requirements, Part 11 controls should be applied to Part 11 records and signatures pursuant to the enforcement policy expressed in this guidance. 4. Copies of Records The Agency intends to exercise enforcement discretion with regard to specific part 11 requirements for generating copies of records (§ 11.10 (b) and any corresponding requirement in §11.30). You should provide an investigator with reasonable and useful access to records during an inspection. All records held by you are subject to inspection in accordance with predicate rules (e.g., §§ 211.180(c), (d), and 108.35(c)(3)(ii)). We recommend that you supply copies of electronic records by: ? Producing copies of records held in common portable formats when records are maintained in these formats ? Using established automated conversion or export methods, where available, to make copies in a more common format (examples of such formats include, but are not limited to, PDF, XML, or SGML) In each case, we recommend that the copying process used produces copies that preserve the content and meaning of the record. If you have the ability to search, sort, or trend part 11 records, copies given to the Agency should provide the same capability if it is reasonable and technically feasible. You should allow inspection, review, and copying of records in a human readable form at your site using your hardware and following your established procedures and techniques for accessing records. 标准，如果适用的话） 如果系统在1997年8月20号后变更，且变更会引起系统不满足预定法规，就要按照该指南中描述的执行政策管理第11条款中的记录和签名。 4.记录的复印 就第11条款中对记录复印的要求，FDA打算采取自由裁量权（§ 11.10 (b)和§11.30相应要求）。检查期间，企业要向检察官提供合理有用的记录。所有保存记录要接受符合预定法规检查（如§§ 211.180(c)，(d)，108.35(c)(3)(ii)） FDA建议企业通过以下方式提供电子记录复印件： ? 当记录按照常见方式保存时，以常见便携方式复印记录 ? 使用已建立的自动转换或输出方法，常见形式有PDF，XML，SGML等 FDA建议无论哪种复印方式，都要保存复印记录的内容和意图。如果可以搜索、归类或趋向第11条款记录，技术上合理并且可行的话，递交FDA的复印件也应一样。企业应该允许通过硬件可读方式检查、审核和复制记录文件，并且遵守接触记录文件的相关操作和规定。 Page 11 of 13

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5. Record Retention The Agency intends to exercise enforcement discretion with regard to the part 11 requirements for the protection of records to enable their accurate and ready retrieval throughout the records retention period (§ 11.10 (c) and any corresponding requirement in §11.30). Persons must still comply with all applicable predicate rule requirements for record retention and availability (e.g., §§ 211.180(c),(d), 108.25(g), and 108.35(h)). We suggest that your decision on how to maintain records be based on predicate rule requirements and that you base your decision on a justified and documented risk assessment and a determination of the value of the records over time. FDA does not intend to object if you decide to archive required records in electronic format to nonelectronic media such as microfilm, microfiche, and paper, or to a standard electronic file format (examples of such formats include, but are not limited to, PDF, XML, or SGML). Persons must still comply with all predicate rule requirements, and the records themselves and any copies of the required records should preserve their content and meaning. As long as predicate rule requirements are fully satisfied and the content and meaning of the records are preserved and archived, you can delete the electronic version of the records. In addition, paper and electronic record and signature components can co-exist (i.e., a hybrid situation) as long as predicate rule requirements are met and the content and meaning of those records are preserved. 5.记录保存 就第11条款保存记录，确保保存期间记录的准确性和可检索性（§ 11.10 (c)和§11.30的相应要求），FDA打算采取自由裁量权。企业必须遵守预定法规的所有要求来保存记录（如211.180(c)，(d)， 108.25(g)和108.35(h)）。 FDA建议企业决定如何保存记录要根据预定法规、基于合理的依据和以文件形式记录的风险评估及记录随时间流逝体现的价值。 FDA不干涉企业选择电子形式还是非电子媒体（如微缩胶卷、微缩胶片、纸质文件或标准电子文件格式PDF、XML、SGML等）保存记录。企业必须遵守所有预定法规，所有记录及复印件都应保留内容。只要满足预定法规要求，记录文件都有保存和归档，企业就可以删除电子版本的记录文件。除此之外，在符合预定法规、有保存记录的情况下，纸质和电子记录及签名可以同时存在。 Page 12 of 13

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IV. REFERENCES 参考文献 Food and Drug Administration References 1. Glossary of Computerized System and Software Development Terminology (Division of Field Investigations, Office of Regional Operations, Office of Regulatory Affairs, FDA 1995) (http://www.fda.gov/ora/inspect_ref/igs/gloss.html) 2. General Principles of Software Validation; Final Guidance for Industry and FDA Staff (FDA, Center for Devices and Radiological Health, Center for Biologics Evaluation and Research, 2002) (http://www.fda.gov/cdrh/comp/guidance/938.html) 3. Guidance for Industry, FDA Reviewers, and Compliance on Off-The-Shelf Software Use in Medical Devices (FDA, Center for Devices and Radiological Health, 1999) (http://www.fda.gov/cdrh/ode/guidance/585.html) 4. Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach; A Science and Risk-Based Approach to Product Quality Regulation Incorporating an Integrated Quality Systems Approach (FDA 2002) (http://www.fda.gov/oc/guidance/gmp.html) Industry References 1. The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems, GAMP 4 (ISPE/GAMP Forum, 2001) (http://www.ispe.org/gamp/) 2. ISO/IEC 17799:2000 (BS 7799:2000) Information technology – Code of practice for information security management (ISO/IEC, 2000) 3. ISO 14971:2002 Medical Devices- Application of risk management to medical devices (ISO, 2001)

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