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本帖最后由 julia朱玉姣 于 2017-9-18 21:34 编辑
很早的一篇指南，近期看了一下，贴出来供大家参考。中英文对照的PDF可以下载。中英文对照 官方英文原版
I. INTRODUCTION 概述
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).[1]
本指南意在描述FDA当前对于21CFR第11部分中电子记录和电子签名的范围和适用方面的观点。
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[2],
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.
本文件为那些为满足法律要求或FDA规定的其它部分中要求保存记录或提交信息给FDA的人员，选择以电子方式保存记录和提交指定信息，从而受第11部分管辖的人提供指南。第11部分适用于以电子方式创建、修改、保存、归档、检索或传输任何官方规定中所要求的记录。第11部分也适用于依据FDCA和公众健康服务法案（PHS法案）向FDA提交的电子记录，即使此记录在官方法规（§ 11.1）并未明确指出仍然适用。在FDCA、PHS法案和FDA规定（第11部分以外的规定）中所隐含的要求在本指南文件中引用时作为法规规定。
As an outgrowth of its current good manufacturing
practice (CGMP) initiative for human and animal drugs and biologics,[3] 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 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.
第11部分作为人药和兽药CGMP要求的副产物，FDA正在重新检查其是否适用于所有受FDA监管的产品。我们期望倡议规则制订者在我们重新检查之后能够依据结论修改第11部分。本指南解释了我们将要对第11部分的范围在解释时进行缩小。由于对第11部分的重新检查仍在进行之中，我们倾向于在某些第11部分要求的实施方面给予自由裁量度。也就是说，正如本指南所解释的，我们不想在验证、审计追踪、记录保存和记录复制要求方面采取强制执行措施。但是，记录还是是必须要依据法规要求进行保存和提交，FDA也可以对违反这些法规规定的行为采取强制措施。
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.3 of this guidance.
此外，我们想要执行自由裁量度，无意对本指南第III.C.3部分所述情形下1997年8月20日，第11部分生效日期之前已在运行的系统（通常被称为遗留系统）采取措施（或建议）
Note that part 11 remains in effect and that this exercise of enforcement discretion
applies only as identified in this guidance.
注：第11部分仍然有效，但其仅在本指南所识别的范围内才是强制实施的。
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.
FDA的指南文件，包括本文件，并不产生法律强制义务。相反，指南所述的是FDA当前对某个问题的观点，除引用具体法律法规要求者以外，应仅当作是建议。FDA指南中使用“SHOULD”一词只表示建议或推荐某事，但并不是必须。
II. BACKGROUND 背景
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.
1997年3月，FDA签了了21CFR的第11部分，给出了在某些情形下FDA可接受的电子记录、电子签名和在等同于纸质记录的电子记录上执行书面签名以及纸面上执行的书面签名的标准。这些规定适用于所有的FDA程序范围，意在允许广泛使用电子技术，与FDA保护公众健康的责任是一致的。
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:
在第11部分于1997年8月生效之后，在制药企业、合同商和FDA之间引发了关于法规的诠释和实施的激烈讨论。FDA已经（1）在许多会议上讲了很多关于第11部分的问题，并且与企业和其它利益相关方的代表多次见面，试图倾听更多关于第11部分可能存在的问题；（2）发布了一份符合性方针指南：CPG 7152:17：政策实施：21 CFR第11部分：电子记录；电子签名；以及（3）发布了许多指南草案，包括以下：
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
21 CFR Part 11; 电子记录；电子签名，验证
21 CFR Part 11; 电子记录；电子签名，术语
21 CFR Part 11; 电子记录；电子签名，时间戳
21 CFR Part 11; 电子记录；电子签名，电子记录的维护
21 CFR Part 11; 电子记录的电子复制件
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.
在所有这些沟通中，大家提出了许多担忧，担心对第11部分要求的一些解释会（1）不必要地限制电子技术，违反FDA签发规定的初衷，（2）大大增加合规成本，使其远远超出起草规定时所考量的程度，以及（3）阻碍创新和技术进步，但并不能为公众健康带来重大利益。这些担忧在第11部分要求中尤其反映在验证、审计追踪、记录保存、记录复制和遗留系统上面。
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; 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,[4] 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.
鉴于这些担忧，我们决定重新审核第11部分文件及相关问题，尤其是依据FDA的CGMP初衷。在联邦公报2003年2月4日（68FR5645）中，我们宣布撤回行业指南草案“21 CFR 第11部分：电子记录、电子签名、电子记录的电子复制件”。我们已经决定，当指南草案可能不再代表我们CGMP倡议下的方法时，我们期望最大程度减少企业花在审核和建议指南草案上的时间。因此，在联邦公报2003年2月25日（68 FR 8775）中，我们宣布撤回第11部分关于验证、术语、时间戳、电子记录维护以及CPG 7153.17指南草案文件。我们收到了对这些指南草案的非常有价值的公众建议，我们计划使用这些信息在未来帮助做出对于第11部分的进一步决策。我们不会重新签发这些指南草案文件和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.
我们现在正在重新检查第11部分，我们期望促进规则制订时会修订这些规定的条款。为了避免耗费不必要的资源来符合第11部分要求，我们签发本指南来说明我们想要在重新检查第11部分期间，对第11部分某些要求方面执行自由裁量度。正如之前所提到的，第11部分在此重新检查期间仍然有效。
III. DISCUSSION 讨论
A. Overall Approach to Part 11 Requirements 第11部分要求的总体方法
As described in more detail below, the approach
outlined in this guidance is based on three main elements:
正如以下详细陈述，在本指南中所列的方法是基于3个主要因素：
· Part 11 will be interpreted narrowly; we are now clarifying that fewer
records will be considered subject to part 11.
· 第11部分将的诠释将受到限制，我们现在澄清只有少数记录需要考虑符合第11部分；
· 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 known as legacy
systems).
· 对于那些仍需要符合第11部分要求的记录，我们将在验证、审计追踪、记录保存和记得复制方面以本指南中所述的方式执行自由裁量度，在第11部分生效之前已在运行的系统在全部第11部分要求方面执行自由裁量权；
· We will enforce all predicate rule requirements, including predicate rule
record and recordkeeping requirements.
· 我们将强制实施所有法规规定要求，包括法规规定记录和记录保存要求。
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:
很重要的一点，要注意FDA按本指南所述执行自由裁量仅限于指定的第11部分要求（除开遗留系统以外，至于实施自由裁量程度，在特定情形下，将会更加广泛）。我们意在实施第11部分所有其它条款，包括但不仅限于对§ 11.10中封闭系统的某些控制。例如，我们想要实施与以下控制和要求有关的条款：
· limiting system access to authorized individuals
· 将系统进入权限限制在经过授权的人员中
· use of operational system checks
· 使用操作系统检查
· use of authority checks
· 使用授权检查
· use of device checks
· 使用装置检查
· determination that persons who develop, maintain, or use electronic
systems have the education, training, and experience to perform their assigned tasks
· 确定开发、维护或使用电子系统的人具备实施其所被委派任务的教育、培训和经验
· establishment of and adherence to written policies that hold individuals
accountable for actions initiated under their electronic signatures
· 建立并严格遵守电子签名人问责书面制度
· appropriate controls over systems documentation
· 对系统文件记录的适当控制
· controls for open systems corresponding to controls for closed systems
bulleted above (§ 11.30)
· 对开放系统的控制对应于上列对封闭系统的控制
· requirements related to electronic signatures (e.g., §§ 11.50, 11.70,
11.100, 11.200, and 11.300)
· 电子签名相关要求（例如，§§ 11.50、11.70、11.100、11.200以及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.
我们期望持续符合这些条款，我们会持续实施之。另外，大家必须符合适用的法规规定，需要保存和提交的记录必须保持安全和可靠，符合这些法规规定。
B. Details of Approach - Scope of Part 11 方法详情---第11部分的范围
1. Narrow Interpretation of Scope 范围有限诠释
We understand that there is some confusion about the
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.
我们理解大家对于第11部分的范围有些困惑。有人将第11部分的范围理解的非常广泛。我们相信如此之广的解释有一些可能会导致不必要的控制和成本，可能会阻碍创新的技术发展，而并不能为公众健康带来增益。因此，我们想要澄清一下FDA对第11部分范围的解释其实是很窄的。
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 "using electronic records in lieu of
paper records" under §§ 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.
在对第11部分狭义解释中，对于依据法规规定需要保存或提交给FDA的记录，如果当事人选择使用电子格式替代纸质格式记录，则第11部分就适用。另一方面，如果人们只是使用计算机生成电子记录的纸质投机倒把件，并且这些纸质记录符合所有的适用法规规定的要求，并且当事人依赖于这些纸质记录来实施其受法规监管的活动，则FDA通常不会认为当事人是§§ 11.2(a) 和11.2(b) 项下“使用电子记录替代纸质记录”。在此情形下，所使用的生成纸质记录的计算机系统并不会触发第11部分监管要求。
2. Definition of Part 11 Records 第11部分记录的定义
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):
依据狭义解释，FDA认为第11部分适用于以下电子格式记录和签名（第11部分记录和签名）：
· 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.
· 依据法规规定要求需要保存的记录，和采用电子格式替代纸质格式的记录。另一方面，依据法规规定不需要保存的记录（和任何相关的签名），不论是否以电子格式保存，则不属于第11部分记录。
We recommend that you determine, based on the
predicate rules, whether specific records are part 11 records. We recommend
that you document such decisions.
我们建议你们依据法规规定来确定具体的记录是否第11部分记录。我们建议你们记录下此类决策。
· 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.
· 依据法规规定需要保存的记录，除了纸质格式以外以电子格式保存的记录，以及实施受法规监管的活动时所依赖的记录。
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.
在有些情形下，实际的业务实践可能会控制你是否依据§ 11.2(a)使用电子记录替代纸质记录。例如，如果一份记录依据法规规定要进行保存，而你使用了一台计算机来生成一份电子记录的纸质打印件，但你却并不依赖于电子记录来实施受法规监管的活动，则FDA可能会认为你使用电子记录来替代纸质记录。就是说，FDA可能在确定是否适用第11部分时会考虑到你的业务实践。
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).
因此，我们建议，对于依据法规规定所需保存的每一种记录，你提前确定你是否计划依赖于电子记录，还是准备依赖纸质记录去实施受法规监管的活动。我们建议你记录下此类决策（例如，在标准操作规程（SOP）中，或规范文件中）。
· 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.
· 依据法规规定（即使此记录在FDA的法规里并没有专门识别）以电子格式（假定在92S-0251文件中被识别为当局以电子格式接收的申报类型）提交给FDA的记录。但是，一份记录本身一般不会被提交，但会被用来生成一份申报资源，那么它就不是第11部分记录，除非依据法规规定还要求保存该记录，而该记录是以电子格式来保存的。
· 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 certain events or actions occurred
in accordance with the predicate rule (e.g. approved, reviewed, and verified).
· 等同用作法规规定所要求的手书签名、首写字母和其它常规签名的电子签名。第11部分签名包括用于，例如，记录某些依据法规规定所发生的事件或措施（例如，批准、审核和核对）的电子签名。
C. Approach to Specific Part 11 Requirements 第11部分特定要求的方法
1. Validation 验证
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.
FDA有意对第11部分里计算机系统（§ 11.10(a)和§ 11.30中对应的要求）的验证的具体要求执行自由裁量。尽管人们仍必须遵守所有适用的验证方面的法规规定要求（例如21 CFR 820.70(i)），本指南不应被解读为强加任何额外的验证要求。
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.
我们建议你们在决定是否验证计算机化系统，验证到何种程度时考虑系统对你们符合法规规定要求能力的影响。你们还应该考虑这些系统对所要求记录和签名的准确性、可靠性、完整性、可获得性和真实性的影响。即使法规规定对验证系统没有要求，在有些情形下，可能验证该系统仍是很重要的。
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.
我们建议你们依据经过论证和记录的风险评估决定所采用方法，确定系统对药品质量和安全，以及记录完整性的潜在影响。例如，验证对于仅生成SOP所用的文字处理器并不重要。
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).
更多计算机化系统的指南，参见FDA行业指南和FDA员工指南“软件验证通则”，以及行业指南例如GAMP4指南（参见参考文献）。
2. Audit Trail 审计追踪
The Agency intends to exercise enforcement discretion
regarding specific part 11 requirements related to 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.
FDA有意对第11部分里计算机生成的时候戳审计追踪（§ 11.10 (e), (k)(2)和§ 11.30中对应的要求）有关的具体要求执行自由裁量。尽管人们仍必须遵守所有适用的文件记录方面，例如日期（例如 § 58.130(e)）、时间和事件排序的适用法规规定要求，以及确保修改记录不会妨碍之前录入数据的任何要求。
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.[5] 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.
即使没有法规规定要求记录，例如，日期、时间或特殊情形下的事件顺序，可能需要有审计追踪或其它物理、逻辑或程序安全措施确保记录的信任度和可靠性。我们建议你们根据你们是否适用审计追踪或其它适当措施，依据符合法规规定要求的需求，依据经过论证和文件记录的风险评估，以及对药品质量和安全性和记录完整性的潜在影响的确定来做出决策。我们建议你们依据此评估来实施适当的控制。如果在日常操作中要求用户创建、修改或删除受法规管理的记录，审计追踪可能特别适合。
3. Legacy Systems[6] 遗留系统
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.
FDA有意对第11部分里的所有要求对1997年8月20日之前，即第11部分生效日期前已开始运行的系统执行自由裁量。
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:
这意味着FDA并无意对符合以下标准的系统采取强制措施要求符合任何第11部分要求：
· The system was operational before the effective date.
· 系统在生效日期之前已开始运行
· The system met all applicable predicate rule requirements before the
effective date.
· 系统在生效日期之前符合所有适用的法规规定要求
· The system currently meets all applicable predicate rule requirements.
· 系统目前符合所有适用的法规规定要求
· 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).
· 你们已书面记录下证据论证该系统适合其既定用途（包括具备可接受水平的记录安全性和完整性，适用时）
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.
如果一个系统在1997年8月20日之后进行过变更，并且该变更妨碍该系统符合法规规定要求，则第11部分控制适用于本指南中所表述的实施政策的第11部分记录和签名。
4. Copies of Records 记录复制件
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)).
FDA有意对第11部分里关于记录复制件生成的要求（(§ 11.10 (b)及§11.30中对应要求)执行自由裁量。在检查期间你们应给检查官提供合理有用的权限进入记录。所有你们保存的记录均应依据法规规定要求进行检查（例如§§ 211.180(c), (d)和108.35(c)(3)(ii)）。
We recommend that you supply copies of electronic
records by:
我们建议你们采用以下方式制作电子记录的复制件：
· Producing copies of records held in common portable formats when records
are maintained in these formats
· 如果记录以PDF格式保存，则采用PDF格式复制记录
· 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)
· 使用已有的自动转化或输出方法，如有时，来制作更常格式的复制件（此类格式例子包括但不仅限于PDF、XML或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.
在各案中，我们建议所用的复制流程所生成的复制件能保存记录的内容和含义。如果你有能力对第11部分记录搜索、分类或进行趋势分析，在合理及技术可行前提下，提交给FDA的复制件应提供相同的能力。你们应允许在你们场所可以使用你们的硬件，按你们进入记录的既定程序和技术，以人眼可读格式检查、审核和复制记录。
5. Record Retention 记录保存
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)).
FDA有意对第11部分里关于记录在整个保存期间保持其准确性并且易于检索的保护要求（(§ 11.10 (c)及§11.30中对应要求)执行自由裁量。人员仍必须符合记录保存和可获得性方面所有适用法规规定要求（例如§§ 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.
我们建议你们依据法规规定要求来决定如何保存记录，依据论证过书面风险评估以及记录在较长时间内的价值的确定来做出决策。
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[7] situation) as long as predicate rule requirements are met and the content and
meaning of those records are preserved.
如果你们决定以电子格式归档所需记录至非电子媒体，如微缩胶卷，微缩胶片和纸质文件中，或者存于标准电子文件格式（此类格式例子包括但不仅限于PDF、XML或SGML），FDA无意反对。人们还必须符合所有法规规定要求，以及记录本身和所有所需记录的复制件应保存其内容和含义。只要法规规定要求全部得到满足，记录的内容和含义都保存和归档，那么你们应可以删除记录的电子版本。此外，只要满足法规规定要求，保存这些记录的内容和含义，则纸质和电子记录和签名部件可以共存（即，混合情形）
IV. REFERENCES 参考文献
Food and Drug Administration References FDA参考文献
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)
计算机系统和软件开发术语（FDA，ORA，ORO，现场调查中心，1995年）
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)
软件验证通则：行业指南和FDA员工指南终稿（FDA，CDRH，CBER，2002年）
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)
行业指南：FDA审核员和医疗器械用商业化软件的合规（FDA，CDRH，1999年）
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)
21世纪药物CGMP：基于风险的方法：基于风险的药品质量监管结合整体质量系统方法的科学方法（FDA 2002年）
Industry References 行业参考文献
1. The Good Automated Manufacturing Practice (GAMP) Guide
for Validation of Automated Systems, GAMP 4 (ISPE/GAMP Forum, 2001) (http://www.ispe.org/gamp/)
优良自动化生产规范（GAMP）自动化系统验证指南，GAMP4（ISPE/GAMP论坛2001）
2. ISO/IEC 17799:2000 (BS 7799:2000) Information
technology - Code of practice for information security management (ISO/IEC,
2000)
ISO/IEC 17799:2000 (BS 7799:2000)信息技术---信息安全管理规范实施细则（ISO/IEC, 2000）
3. ISO 14971:2002 Medical Devices- Application of risk
management to medical devices (ISO, 2001)
ISO 14971:2002医疗器械—医疗器械风险管理应用（ISO, 2001）
[1] 62 FR 13430
[2] These requirements include,
for example, certain provisions of the Current Good Manufacturing Practice
regulations (21 CFR Part 211), the Quality System regulation (21 CFR Part 820),
and the Good Laboratory Practice for Nonclinical Laboratory Studies regulations
(21 CFR Part 58). 这些要求包括，例如，CGMP法规（21CFR第211部分）的特定条款，质量体系法规（21CFR第820部分）和非临床实验研究GLP法规（21CFR第58部分）。
[3] See 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 at www.fda.gov/oc/guidance/gmp.html.
[4] Although we withdrew the draft
guidance on time stamps, our current thinking has not changed in that when
using time stamps for systems that span different time zones, we do not expect
you to record the signer's local time. When using time stamps, they should be
implemented with a clear understanding of the time zone reference used. In such
instances, system documentation should explain time zone references as well as
zone acronyms or other naming conventions. 尽管我们撤回时间戳指南草案，我们当前对于在跨越不同时区系统中使用时间戳的观点并没有改变，我们不期望你记录签名者的当地时间。在使用时间戳时，他们应该对所用时区有清楚理解。在此情形下，系统文件记录应解释时区参照以及时区缩写或其它命名惯例。
[5] Various guidance documents on
information security are available (see References).
[6] In this guidance document, we
use the term legacy system to describe systems already in operation before the
effective date of part 11. 在本指南文件中，我们使用术语遗留系统来描述在第11部分生效日期之前已开始运行的系统。
[7] Examples of hybrid situations
include combinations of paper records (or other nonelectronic media) and
electronic records, paper records and electronic signatures, or handwritten
signatures executed to electronic records. 混合情形的例子包括纸质记录（或其它非电子媒介）和电子记录，纸质记录和电子签名，或对电子记录执行手工签字的组合。
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