FDA 21 CFR Part 11
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
【最新整理，下载后即可编辑】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。
美国联邦法规21章第11款
联邦法规21章第11款21 CFR Part 11 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FD A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。
21CFR-part11-中文
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。
21-CFR-Part-11介绍讲解
-Centralized Laboratory -Data Acquisition & Reporting -Remote Data Entry -Case Report Form Systems -Clinical Data management -Adverse Event Reporting -Clinical Supply Systems -Statistical Analysis Systems
系统验证
误区二
软件符合（compliant）21 CFR Part 11
体系的符合性，除软件外，还包括体系内硬 件、SOPs、人员培训和管理的对21 CFR Part 11 的符合性。
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CFR Part 11概述
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CFR Part 11内容解读 CFR Part 11应用
CFR = Code of Federal Regulations 美国联邦法规21章第11款 电子记录和电子签名 /scripts/cdrh/cfdocs/ cfcfr/cfrsearch.cfm?cfrpart=11
概述
1997年8月20日颁布实施的法规 适用于包括现有体系内所有FDA监管的工 作中的电子记录 电子签名和电子记录的准则：可信的和可 靠的 电子签名 = 手写签名 最低要求 / 防止假冒
绪论 正文
从企业反馈中整理出来的问题解释
法规本身
目录
TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER A--GENERAL PART 11 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES Subpart A--General Provisions § 11.1 - Scope. § 11.2 - Implementation. § 11.3 - Definitions. Subpart B--Electronic Records § 11.10 - Controls for closed systems. § 11.30 - Controls for open systems. § 11.50 - Signature manifestations. § 11.70 - Signature/record linking. Subpart C--Electronic Signatures § 11.100 - General requirements. § 11.200 - Electronic signature components and controls. § 11.300 - Controls for identification codes/passwords.
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
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。
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。
FDA 21 CFR Part 11
Electronic Code of Federal RegulationsTitle 21: Food and DrugsPart 11—Electronic Records; Electronic Signatures e-CFR data is current as of February 23, 2017ContentsSubpart A—General Provisions§11.1 Scope.§11.2 Implementation.§11.3 Definitions.Subpart B—Electronic Records§11.10 Controls for closed systems.§11.30 Controls for open systems.§11.50 Signature manifestations.§11.70 Signature/record linking.Subpart C—Electronic Signatures§11.100 General requirements.§11.200 Electronic signature components and controls.§11.300 Controls for identification codes/passwords.Authority: 21 U.S.C. 321-393; 42 U.S.C. 262.Source: 62 FR 13464, Mar. 20, 1997, unless otherwise noted.Subpart A—General Provisions§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.(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.(c) Where electronic signatures and their associated electronic records meet the requirements of this part, the agency will consider the electronic signatures to be equivalent to full handwritten signatures, initials, and other general signings as required by agency regulations, unless specifically excepted by regulation(s) effective on or after August 20, 1997.(d) Electronic records that meet the requirements of this part may be used in lieu of paper records, in accordance with §11.2, unless paper records are specifically required.(e) Computer systems (including hardware and software), controls, and attendant documentation maintained under this part shall be readily available for, and subject to, FDA inspection.(f) This part does not apply to records required to be established or maintained by §§1.326 through 1.368 of this chapter. Records that satisfy the requirements of part 1, subpart J of this chapter, but that also are required under other applicable statutory provisions or regulations, remain subject to this part.(g) This part does not apply to electronic signatures obtained under §101.11(d) ofthis chapter.(h) This part does not apply to electronic signatures obtained under §101.8(d) of this chapter.(i) This part does not apply to records required to be established or maintained by part 117 of this chapter. Records that satisfy the requirements of part 117 of this chapter, but that also are required under other applicable statutory provisions or regulations, remain subject to this part.(j) This part does not apply to records required to be established or maintained by part 507 of this chapter. Records that satisfy the requirements of part 507 of this chapter, but that also are required under other applicable statutory provisions or regulations, remain subject to this part.(k) This part does not apply to records required to be established or maintained by part 112 of this chapter. Records that satisfy the requirements of part 112 of this chapter, but that also are required under other applicable statutory provisions or regulations, remain subject to this part.(l) This part does not apply to records required to be established or maintained by subpart L of part 1 of this chapter. Records that satisfy the requirements of subpart L of part 1 of this chapter, but that also are required under other applicable statutory provisions or regulations, remain subject to this part.(m) This part does not apply to records required to be established or maintained by subpart M of part 1 of this chapter. Records that satisfy the requirements of subpart M of part 1 of this chapter, but that also are required under other applicable statutory provisions or regulations, remain subject to this part.(n) This part does not apply to records required to be established or maintained by subpart O of part 1 of this chapter. Records that satisfy the requirements of subpart O of part 1 of this chapter, but that also are required under other applicable statutory provisions or regulations, remain subject to this part.(o) This part does not apply to records required to be established or maintained by part 121 of this chapter. Records that satisfy the requirements of part 121 of this chapter, but that also are required under other applicable statutory provisions or regulations,remain subject to this part.[62 FR 13464, Mar. 20, 1997, as amended at 69 FR 71655, Dec. 9, 2004; 79 FR 71253, 71291, Dec. 1, 2014; 80 FR 71253, June 19, 2015; 80 FR 56144, 56336, Sept. 17, 2015; 80 FR 74352, 74547, 74667, Nov. 27, 2015; 81 FR 20170, Apr. 6, 2016; 81 FR 34218, May 27, 2016]§11.2 Implementation.(a) For records required to be maintained but not submitted to the agency, persons may use electronic records in lieu of paper records or electronic signatures in lieu of traditional signatures, in whole or in part, provided that the requirements of this part are met.(b) For records submitted to the agency, persons may use electronic records in lieu of paper records or electronic signatures in lieu of traditional signatures, in whole or in part, provided that:(1) The requirements of this part are met; and(2) The document or parts of a document to be submitted have been identifiedin public docket No. 92S-0251 as being the type of submission the agency accepts in electronic form. This docket will identify specifically what types of documents or parts of documents are acceptable for submission in electronic form without paper records and the agency receiving unit(s) (e.g., specific center, office, division, branch) to which such submissions may be made. Documents to agency receiving unit(s) not specified in the public docket will not be considered as official if they are submitted in electronic form; paper forms of such documents will be considered as official and must accompany any electronic records. Persons are expected to consult with the intended agency receiving unit for details on how (e.g., method of transmission, media, file formats, and technical protocols) and whether to proceed with the electronic submission.§11.3 Definitions.(a) The definitions and interpretations of terms contained in section 201 of the act apply to those terms when used in this part.(b) The following definitions of terms also apply to this part:(1) Act means the Federal Food, Drug, and Cosmetic Act (secs. 201-903 (21 U.S.C. 321-393)).(2) Agency means the Food and Drug Administration.(3) Biometrics means a method of verifying an individual's identity based on measurement of the individual's physical feature(s) or repeatable action(s) where those features and/or actions are both unique to that individual and measurable.(4) Closed system means an environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system.(5) Digital signature means an electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified.(6) Electronic record means any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.(7) Electronic signature means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature.(8) Handwritten signature means the scripted name or legal mark of an individual handwritten by that individual and executed or adopted with the present intention to authenticate a writing in a permanent form. The act of signing with a writing or marking instrument such as a pen or stylus is preserved. The scripted name or legal mark, while conventionally applied to paper, may also be applied to other devices that capture the name or mark.(9) Open system means an environment in which system access is not controlled by persons who are responsible for the content of electronic records that are on the system.Subpart B—Electronic Records§11.10 Controls for closed systems.Persons who use closed systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records, and to ensure that the signer cannot readily repudiate the signed record as not genuine. Such procedures and controls shall include the following:(a) Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.(b) The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency. Persons should contact the agency if there are any questions regarding the ability of the agency to perform such review and copying of the electronic records.(c) Protection of records to enable their accurate and ready retrieval throughout the records retention period.(d) Limiting system access to authorized individuals.(e) Use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. Record changes shall not obscure previously recorded information. Such audit trail documentation shall be retained for a period at least as long as that required for the subject electronic records and shall be available for agency review and copying.(f) Use of operational system checks to enforce permitted sequencing of steps and events, as appropriate.(g) Use of authority checks to ensure that only authorized individuals can use the system, electronically sign a record, access the operation or computer system input or output device, alter a record, or perform the operation at hand.(h) Use of device (e.g., terminal) checks to determine, as appropriate, the validity of the source of data input or operational instruction.(i) Determination that persons who develop, maintain, or use electronic record/electronic signature systems have the education, training, and experience to perform their assigned tasks.(j) The establishment of, and adherence to, written policies that hold individuals accountable and responsible for actions initiated under their electronic signatures, in order to deter record and signature falsification.(k) Use of appropriate controls over systems documentation including:(1) Adequate controls over the distribution of, access to, and use ofdocumentation for system operation and maintenance.(2) Revision and change control procedures to maintain an audit trail thatdocuments time-sequenced development and modification of systems documentation.§11.30 Controls for open systems.Persons who use open systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, as appropriate, the confidentiality of electronic records from the point of their creation to the point of their receipt. Such procedures and controls shall include those identified in §11.10, as appropriate, and additional measures such as document encryption and use of appropriate digital signature standards to ensure, as necessary under the circumstances, record authenticity, integrity, and confidentiality.§11.50 Signature manifestations.(a) Signed electronic records shall contain information associated with the signing that clearly indicates all of the following:(1) The printed name of the signer;(2) The date and time when the signature was executed; and(3) The meaning (such as review, approval, responsibility, or authorship)associated with the signature.(b) The items identified in paragraphs (a)(1), (a)(2), and (a)(3) of this sectionshall be subject to the same controls as for electronic records and shall be includedas part of any human readable form of the electronic record (such as electronic display or printout).§11.70 Signature/record linking.Electronic signatures and handwritten signatures executed to electronic records shall be linked to their respective electronic records to ensure that the signatures cannot be excised, copied, or otherwise transferred to falsify an electronic record by ordinary means.Subpart C—Electronic Signatures§11.100 General requirements.(a) Each electronic signature shall be unique to one individual and shall not be reused by, or reassigned to, anyone else.(b) Before an organization establishes, assigns, certifies, or otherwise sanctions an individual's electronic signature, or any element of such electronic signature, the organization shall verify the identity of the individual.(c) Persons using electronic signatures shall, prior to or at the time of such use, certify to the agency that the electronic signatures in their system, used on or after August 20, 1997, are intended to be the legally binding equivalent of traditional handwritten signatures.(1) The certification shall be submitted in paper form and signed with atraditional handwritten signature, to the Office of Regional Operations (HFC-100), 5600 Fishers Lane, Rockville, MD 20857.(2) Persons using electronic signatures shall, upon agency request, provideadditional certification or testimony that a specific electronic signature is the legally binding equivalent of the signer's handwritten signature.§11.200 Electronic signature components and controls.(a) Electronic signatures that are not based upon biometrics shall:(1) Employ at least two distinct identification components such as anidentification code and password.(i) When an individual executes a series of signings during a single,continuous period of controlled system access, the first signing shall beexecuted using all electronic signature components; subsequent signings shallbe executed using at least one electronic signature component that is onlyexecutable by, and designed to be used only by, the individual.(ii) When an individual executes one or more signings not performed during a single, continuous period of controlled system access, each signingshall be executed using all of the electronic signature components.(2) Be used only by their genuine owners; and(3) Be administered and executed to ensure that attempted use of anindividual's electronic signature by anyone other than its genuine owner requires collaboration of two or more individuals.(b) Electronic signatures based upon biometrics shall be designed to ensure that they cannot be used by anyone other than their genuine owners.§11.300 Controls for identification codes/passwords.Persons who use electronic signatures based upon use of identification codes in combination with passwords shall employ controls to ensure their security and integrity. Such controls shall include:(a) Maintaining the uniqueness of each combined identification code and password, such that no two individuals have the same combination of identification code and password.(b) Ensuring that identification code and password issuances are periodically checked, recalled, or revised (e.g., to cover such events as password aging).(c) Following loss management procedures to electronically deauthorize lost, stolen, missing, or otherwise potentially compromised tokens, cards, and other devices that bear or generate identification code or password information, and to issue temporary or permanent replacements using suitable, rigorous controls.(d) Use of transaction safeguards to prevent unauthorized use of passwords and/or identification codes, and to detect and report in an immediate and urgent manner anyattempts at their unauthorized use to the system security unit, and, as appropriate, to organizational management.(e) Initial and periodic testing of devices, such as tokens or cards, that bear or generate identification code or password information to ensure that they function properly and have not been altered in an unauthorized manner.11 / 11。
21 CFR Part 11介绍
张 俊 2011.7
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CFR Part 11概述
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CFR Part 11内容解读 CFR Part 11应用
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CFR Part 11概述
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CFR Part 11内容解读 CFR Part 11应用
什么是21 CFR Part 11
§11.10 封闭系统的管理
(g) 使用验证检查以保证只有被授权用户才可以使用系统，以电子方 式签署记录，使用操作或计算机系统的输入输出设备，改变记录或手 工执行操作。 系统可以保证，只有授权人员可以使用系统、电子签名记录、访问运 行或计算机系统的输入或输出装置来改变记录或执行其它操作吗？ (h) 必要时使用设备（举例来说，终端）检查以确定数据输入来源或 操作指导的有效性。 如果系统要求输入数据或指令，只是来源于某一特定的输入装置（如 终端），则系统是否检查接收的数据或指令的有效性？ (i) 确定开发、维护或使用电子记录/电子签名系统的人员应具备与 执行他们被指派的任务相应的教育、培训和经验。 是否对系统用户、开发人员、IT 支持人员提供培训，包括在岗培训？
§11.2 执行
(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。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。人们期望与未来的FDA接收 单位就详细的（举例来说，传送的方法、媒体、文件格式和技术协议） 怎样和是否进行电子的提交物进行协商。
为什么生物医药软件要遵守FDA 21 CFR Part 11
21CFR（Code of Federal Regulations,Title21Food and Drugs）是美国于1997年颁布的关于食品与药品的法规，并于2003年颁布相关行业指南来细化有关规则。
换言之，整个21CFR其实就是美国联邦法律中关于食品和药品的部分，属于美国FDA管辖的范围，内容包括Part1到Part1499。
人们耳熟能详的一些规范，例如GLP、GCP和GMP等都属21CFR。
而21CFR Part11则是指美国联邦法规第21章第11款，主要内容涉及电子记录和电子签名。
在该规定中，电子记录被认为具有与书面记录和手写签名同等的效力。
医疗、制药、检测检验以及食品生产相关的软件系统，如果要加入到美国的GMP、GLP、GSP等质量管理体系中，必须符合21CFR Part11。
21CFR Part11分为3章，分别是：为什么大家都遵循21CFR Part11？作为美国的法规，21CFR Part11被美国的生物医药企业、医院、研究所和实验室广泛接受并遵照执行，美国作为全球生物医药产业最主要组成部分其影响力巨大，当他国生产制造的药物、生物医药相关设备或者信息系统需要销售到美国时都必须符合21CFR Part11的规定。
如违反，FDA可以依法剥夺这些产品销售到美国的权利。
21CFR Part11从1997年颁布以来已被推广至全球，虽然没有强制性，但被欧洲、亚洲等地区普遍接受和使用。
其他国家对电子记录和电子签名也会颁布类似的法规，但多以21CFR Part11作为参考指导。
计算机系统验证与21CFR Part11之间的关系不管是否使用电子签名，企业只要在GxP环境下使用计算机系统创建电子记录，就不能脱离Part11的规定。
所有所涉及到的计算机系统都必须有技术措施和管理措施以保证达到下面4项要求：1、生成准确的记录并且对其完整备份的能力，保证数据完整性的延续性；2、带时间印记的审计跟踪记录的可用性；3、记录的保存，对记录进行保护以确保记录准确并且随时能查阅；4、合适的系统访问和身份检查机制，即限制性访问措施。
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FDA 21 CFR Part 11
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。
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。
人们期望与未来的FDA接收单位就详细的（举例来说，传送的方法、媒体、文件格式和技术协议）怎样和是否进行电子的提交物进行协商。
定义(a) 包含于法案201部分中术语的定义和翻译同样适用于那些在本条款中使用到的术语。
(b) 下列术语的定义同样适用于本条款
(1)法案是指联邦食品、药品、化妆品法案
(2)机构是指美国食品和药品管理局（FDA）
(3) 生物测定学是指一种基于个人的身体特征及重复行为（这些特征和行为对个人来说是唯一的和可以测量的）的测量来校验个人身份的方法。
(4)封闭的系统是指一种环境，在此环境中系统的登录是被那些对系统上电子记录的内容负责的人们所控制。
(5)数字签名是指一种基于发信方鉴别加密的方法，使用一套规则和一系列参数计算以使签名者的身份和数据的完整性能被校验。
(6)电子记录是指任何文本、图表、数据、声音、图示的或其他的以电子形式表现的信
息的混合，它的建立、修改、维护、归档、检索或分发是由计算机系统来完成的。
(7) 电子签名是指一种由一个人执行、采用或批准成为与其个人的
手写签名具有相同的法律效力的计算机数据的任意符号或一系列符号的编译。
(8)手签名是指个人的手迹签名或合法的标志，以永久的形式书写真实意图所采纳的个人签名或合法标志。
用书写及标志工具（例如一支钢笔或尖笔）的签字行为是被保存的。
手写签名或合法的标志当约定俗成地适用于书面上，也可以适用于其它的获取名字及标志的设备。
(9)开放系统是指一种环境，在此环境中系统的登录不是被那些对系统上电子记录的内容负责的人所控制。
实际应用实际应用常以符合FDA 21 CFR Part 11 方式表达。
食品、医药制造行业多遵照此标准。
只用遵照此标准，其厂商生产的产品才可以正常销往国外市场，并且遵照此标准而保留的数据才可以作为通过检验或者今后追溯的有效数据来源。
现在很多大型自动化控制系统已经符合此标准规定。
此法规确保了电子数据的有效性和可靠性。