21CFR11-電子記錄及電子簽名

1、Title 21 Chapter I Subchapter A Part11TITLE 21 Food and Drugs 食品和藥品CHAPTER I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTHANDHUMAN SERVICES 食品藥品管理局，衛(wèi)生福利部SUBCHAPTER A GENERAL 通則PART 11 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES 電子記錄，電子簽名Sec. 11.1 Scope.范圍(a) The regulations in this part set forth

2、 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.本部分的規(guī)定設(shè)定了FDA 認為電子記錄、電子簽名和對電子記錄所實施的手寫

3、簽名可靠可信，并且通常等同于紙質(zhì)記錄和在紙上手書簽名的標準。(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 re

4、quirements 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.本部分適用于依FDA 法規(guī)中設(shè)定的記錄要求創(chuàng)建、修改、

5、維護、歸檔、檢索或傳送的電子形式記錄。本部分也適用于依聯(lián)邦食品藥品化妝品法案和 公眾健康服務(wù)法案要求提交給FDA 的電子記錄，即使此記錄未在FDA 法規(guī)中明確被識別。但是，此部分不適用于將采用或已采用電子方式傳輸?shù)募堎|(zhì)記錄。(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 hand

6、written signatures, initials, and other general signings as required by agency regulations, unless specifically excepted by regulation(s) effective on or after August 20, 1997.如果電子簽名和與它相關(guān)的電子記錄符合本部分的要求，F(xiàn)DA 將會認為電子簽名等同于完全手寫簽名、縮寫簽名和其他的FDA 法規(guī)所求的一般簽名，1997 年 8 月 20 日之后生效的法規(guī)明確排除者除外。(d) Electronic records th

7、at 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.除特別要求使用紙質(zhì)記錄者外，依據(jù)§ 11.2， 符合本部分要求的電子記錄可用以替代紙質(zhì)記錄。(e) Computer systems (including hardware and software), controls, and attendant documentation ma

8、intained under this part shall be readily available for, and subject to, FDA inspection.依本部分要求維護的計算機系統(tǒng)(包括硬件和軟件)、控制權(quán)、和隨附的文件在FDA 檢查期間應(yīng)可以提供。(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 requ

9、irements 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.這部分內(nèi)容不適用于根據(jù)本章§§1.326 至 § §1.368 要求而建立或維護的記錄。本章1.326部分至 1.368 部分所要求的記錄，如其它適用法律法規(guī)條款也需要，則仍須符合本部分要求。(g) This part does not

10、 apply to electronic signatures obtained under 101.11(d) of this chap§ ter. 本部分不適用于依本章§ 101.11(d)所獲得的電子簽名。This part does not apply to electronicsignatures obtained under 101.8(d§) of this chapter.本部分不適用于依本章§ 101.8(d)所獲得的電子簽名。(i) This part does not apply to records required to be

11、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. 本部分不適用于根據(jù)本章第117 部分要求而建立和保存的記錄。本章第 117 部分所要求的記錄，如其它適用法律法規(guī)條款也需要，

12、則仍須符合本部分要求。(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 pa

13、rt. 本部分不適用于根據(jù)本章第507 部分要求而建立和保存的記錄。本章第 507 部分所要求的記錄，如其它適用法律法規(guī)條款也需要，則仍須符合本部分要求。(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 applica

14、ble statutory provisions or regulations, remain subject to this part. 本部分不適用于根據(jù)本章第112 部分要求而建立和保存的記錄。本章第 112 部分所要求的記錄，如其它適用法律法規(guī)條款也需要，則仍須符合本部分要求。(l) This part does not apply to records required to be established or maintained by subpart L of part1 of this chapter. Records that satisfy the requirements

15、 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.本部分不適用于根據(jù)本章第1 部分第 L 子部要求而建立和保存的記錄。本章第 1 部分第 L子部所要求的記錄，如其它適用法律法規(guī)條款也需要，則仍須符合本部分要求。(m) This part does not apply to records required to be establish

16、ed 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.本部分不適用于根據(jù)本章第1 部分第 M 子部要求而建立和保存的記錄。本章第1 部分第M 子部所要求的

17、記錄，如其它適用法律法規(guī)條款也需要，則仍須符合本部分要求。(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 o

18、r regulations, remain subject to this part.本部分不適用于根據(jù)本章第1 部分第 O 子部要求而建立和保存的記錄。本章第1 部分第O 子部所要求的記錄，如其它適用法律法規(guī)條款也需要，則仍須符合本部分要求。(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, b

19、ut that also are required under other applicable statutory provisions or regulations, remain subject to this part.本部分不適用于根據(jù)本章第121 部分要求而建立和保存的記錄。本章第 121 部分所要求的記錄，如其它適用法律法規(guī)條款也需要，則仍須符合本部分要求。Sec. 11.2 Implementation. 實施(a) For records required to be maintained but not submitted to the agency, persons ma

20、y 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.需要維護但不需提交給FDA 的記錄，如果符合本部分的要求，可以使用全部或部分電子記錄代替紙制記錄或用電子簽名代替?zhèn)鹘y(tǒng)簽名。(b) For records submitted to the agency, persons may use

21、 electronic records in lieu of paper records or electronic signatures in lieu of traditional signatures, in whole or in part, provided that:在滿足以下條件時，提交給FDA 的記錄可以全部或部分使用電子記錄代替紙制記錄或電子簽名代替?zhèn)鹘y(tǒng)簽名：(1) The requirements of this part are met; and 符合本部分的要求；以及(2) The document or parts of a document to be submit

22、ted have been identified in 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 rec

23、eiving 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 consider

24、ed 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.要提交的文件或部分文件在公眾文案92S-

25、0251 中被列為FDA 可以用電子形式提交的文件類型。 此文案中會列出哪些類型的文件或文件的哪些部分可以接受電子提交，而不需要紙質(zhì)記錄，以及需要提交給哪個部門(例如，指定的中心、辦公室、支部、分部)。在公眾文案中未列出的文件如果以電子形式提交，則不會被認為是正式文件，此類文件的紙質(zhì)文件才是正式文件，必須與電子記錄一起提交。申報人可咨詢接收文件的FDA 部門詳細了解要如何提交(例如，傳送方法、介質(zhì)、文件格式和技術(shù)方案)以及是否需要同時提交電 子申報。Sec. 11.3 Definitions. 定義(a) The definitions and interpretations of terms

26、 contained in section 201 of the act apply to those terms when used in this part.法案第 201 部分中的術(shù)語定義和解釋用于本部分時適用于這些術(shù)語。(b) The following definitions of terms also apply to this part: 下列術(shù)語的定義同樣適用于本部分：(1)Act means the Federal Food, Drug, and Cosmetic Act (secs. 201-903 (21 U.S.C. 321-393).法案指聯(lián)邦食品、藥品、化妝品法案(

27、第 201-903 部分( 21 U.S.C. 321-393) ) 。(2)Agency means the Food and Drug Administration. 機構(gòu)是指美國食品和藥品管理局。(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

28、 both unique to that individual and measurable.生物特征識別是指一種通過測量個人唯一且可測量的身體特征及重復(fù)行為來核對個人身 份的方法。(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. 封閉系統(tǒng)是指系統(tǒng)的進入由對系統(tǒng)上電子記錄內(nèi)容負責的人所控制的環(huán)境。(5)Digit

29、al 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.數(shù)字簽名是指一種基于發(fā)信方認證的加密方法的電子簽名，它使用一套規(guī)則和一系列參數(shù)計算以使簽名者的身份和數(shù)據(jù)的完

30、整性能被核對。(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.電子記錄是指文本、圖表、數(shù)據(jù)、聲音、圖片或其他以數(shù)字形式呈現(xiàn)的信息組合，它由計 算機系統(tǒng)創(chuàng)建、修改、維護、歸檔、檢索或

31、分布。(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.電子簽名是指由個人執(zhí)行、采用或授權(quán)的任何符號或符號系列的計算機數(shù)據(jù)編譯，該簽名與個人手書簽名具有等同法律效力。(8)Handwritten s

32、ignature 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

33、name or legal mark, while conventionally applied to paper, may also be applied to other devices that capture the name or mark.手書簽名指個人手書的姓名或法定標記，由該人以永久的方式表現(xiàn)真實意圖并實際書寫。采用書寫或記號工具，如鋼筆或手寫筆簽名的動作被留存下來。手書姓名或法定標記，雖然傳統(tǒng)地應(yīng)用于紙張簽名，但也可以適用于其它能捕獲姓名或標記的裝置。(9)Open system means an environment in which system access is n

34、ot controlled by persons who are responsible for the content of electronic records that are on the system.開放系統(tǒng)是指系統(tǒng)的進入不由對系統(tǒng)上電子記錄內(nèi)容負責的人所控制的環(huán)境。Subpart B-Electronic Records 電子記錄Sec. 11.10 Controls for closed systems. 封閉系統(tǒng)的控制Persons who use closed systems to create, modify, maintain, or transmit electron

35、ic 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 fo

36、llowing: 使用封閉系統(tǒng)建立、修改、 維?；騻魉碗娮佑涗洉r，應(yīng)使用設(shè)計為可確保電子記錄真實性、完整性和保密性(適當時)的程序和控制，以及確保簽名者不能輕易否認已經(jīng)簽署記錄的真實性。此類程序和控制應(yīng)包括：(a) Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.系統(tǒng)的驗證，以確保其準確性、可靠性、穩(wěn)定的既定性能，以及識別無效和被篡改記錄的能力。(b) The

37、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 th

38、e electronic records.確保生成適合FDA 檢查、 審核和復(fù)制的人可讀和電子形式的準確完整記錄副本的能力。如果對于FDA 是否能對其電子記錄實施審核和復(fù)制存疑，應(yīng)聯(lián)系FDA。(c) Protection of records to enable their accurate and ready retrieval throughout the records retention period. 對記錄進行保護，使其在整個保存期內(nèi)準確和易于檢索。(d) Limiting system access to authorized individuals. 將系統(tǒng)進入權(quán)限限制于經(jīng)過授

39、權(quán)的人(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 r

40、etained for a period at least as long as that required for the subject electronic records and shall be available for agency review and copying.使用計算機生成的具有時間戳的安全的審計追蹤獨立記錄操作人員輸入的日期和創(chuàng)建、修改和刪除電子記錄的動作。記錄變更不應(yīng)妨礙讀取之前的所記錄信息。此審計追蹤文件應(yīng)保存至少與其對應(yīng)的電子記錄所需保存相同時長，并可供FDA 審核和復(fù)制。(f) Use of operational system checks to enfo

41、rce permitted sequencing of steps and events, as appropriate.必要時，使用操作系統(tǒng)檢查以強化步驟和事件的排序。(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

42、 operation at hand.使用權(quán)限檢查確保只有經(jīng)過授權(quán)的用戶才可以使用系統(tǒng)、以電子方式簽署記錄、使用操作或計算機系統(tǒng)的輸入輸出設(shè)備、修改記錄和執(zhí)行操作。(h) Use of device (e.g., terminal) checks to determine, as appropriate, the validity of the source of data input or operational instruction.適當時，使用設(shè)備(例如，終端)檢查以確定數(shù)據(jù)輸入來源或操作指令的有效性。(i) Determination that persons who develop

43、, maintain, or use electronic record/electronic signature systems have the education, training, and experience to perform their assigned tasks. 確定開發(fā)、維護和使用電子記錄/電子簽名系統(tǒng)的人員具備相應(yīng)的教育、培訓(xùn)和經(jīng)驗完成其指定任務(wù)。(j) The establishment of, and adherence to, written policies that hold individuals accountable and responsible

44、for actions initiated under their electronic signatures, in order to deter record and signature falsification.制訂并堅守書面方針，要求簽字人員對其電子簽名所針對的動作承擔責任，防止記錄和簽名偽造。(k) Use of appropriate controls over systems documentation including: 對系統(tǒng)文件進行適當?shù)目?制包括：(l) Adequate controls over the distribution of, access to, an

45、d use of documentation for system operation and maintenance.對系統(tǒng)運行和維護所用文件的分發(fā)、獲取和使用實施充分的控制。(m) Revision and change control procedures to maintain an audit trail that documents time-sequenced development and modification of systems documentation 建立修訂和變更控制程序，維護審計追蹤記錄系統(tǒng)文件的時序開發(fā)和修改。Sec. 11.30 Controls for

46、open systems. 開放系統(tǒng)的控制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 po

47、int 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 conf

48、identiality.使用開放系統(tǒng)建立、修改、 保持和傳送電子記錄時，應(yīng)使用設(shè)計以確保電子記錄自其創(chuàng)建開始至其接收時為止的真實性、完整性和保密性(適當時)。 此類程序和控制應(yīng)包括§ 11.10中所識別的內(nèi)容，適當時，還應(yīng)有其它程序，如文件加密和使用適當?shù)臄?shù)字簽名標準，以確保(如環(huán)境必須)記錄真實性、完整性和保密性。Sec. 11.50 Signature manifestations.簽名顯示(a) Signed electronic records shall contain information associated with the signing that clearly

49、 indicates all of the following: 所簽署的電子記錄應(yīng)清晰顯示以下與簽名相關(guān)的信息：(1) The printed name of the signer; 簽名者打印姓名；(2) The date and time when the signature was executed; and 簽名日期和時間；以及(3) The meaning (such as review, approval, responsibility, or authorship) associated with the signature.簽名含義(如審核、批準、職責或作者身份)。(b) T

50、he items identified in paragraphs (a)(1), (a)(2), and (a)(3) of this section shall be subject to the same controls as for electronic records and shall be included as part of any human readable form of the electronic record (such as electronic display or printout).在本部分第(a)(1)、 (a)(2)和 (a)(3)段所識別的項目應(yīng)受

51、到與電子記錄相同的控制，應(yīng)作為人可讀形式電子記錄的一部分(例如，電子顯示或打印件)。Sec. 11.70 Signature/record linking. 簽名/記錄鏈接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 transferr

52、ed to falsify an electronic record by ordinary means.電子記錄上簽署的電子簽名和手書簽名應(yīng)鏈接到其對應(yīng)的電子記錄，以保證電子簽名不能刪除、拷貝或者其他方式的轉(zhuǎn)移用于使用普通手段偽造電子記錄。Subpart C-Electronic Signatures 電子簽名Sec. 11.100 General requirements.通用要求(a) Each electronic signature shall be unique to one individual and shall not be reused by, or reassigned

53、to, anyone else.每一電子簽名應(yīng)唯一對應(yīng)一個人，且不得再次使用或重新分配給其他任何人。(b) Before an organization establishes, assigns, certifies, or otherwise sanctions an individuals electronic signature, or any element of such electronic signature, the organization shall verify the identity of the individual.在組織機構(gòu)建立、分配、證明、或批準一個人的電子簽

54、名，或任何其他此類電子簽名 要素前，組織機構(gòu)應(yīng)核實該人身份。(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 signa

55、tures.使用電子簽名者，在使用之前或使用時，應(yīng)向FDA 證明，自1997 年 8 月 20 日起其他們系統(tǒng)所用的電子簽名與傳統(tǒng)的手寫簽名有同等的法律效力。(1) The certification shall be submitted in paper form and signed with a traditional handwritten signature, to the Office of Regional Operations (HFC-100), 12420 Parklawn Drive, RM 3007 Rockville, MD 20857.證明應(yīng)以紙質(zhì)方式提交到“地方運

56、營辦公室”( HFC-100, 5600 Fishers Lane,Rockville,MD 20857 )并以傳統(tǒng)方式手寫簽名。(2) Persons using electronic signatures shall, upon agency request, provide additional certification or testimony that a specific electronic signature is the legally binding equivalent of the signers handwritten signature.依 FDA 要求，電子簽名

57、使用者應(yīng)提供一份額外聲明或證明，聲明其電子簽名與其手書簽名具有同等法律效力。Sec. 11.200 Electronic signature components and controls. 電子簽名組件和控件(a) Electronic signatures that are not based upon biometrics shall: 非生物學(xué)特征的電子簽名 應(yīng)：(1) Employ at least two distinct identification components such as an identification code and password. 使用至少兩種截然不

58、同的證明要件，例如識別碼和密碼。(i) When an individual executes a series of signings during a single, continuous period of controlled system access, the first signing shall be executed using all electronic signature components; subsequent signings shall be executed using at least one electronic signature component that is only executable by, and designed to be used only by, the individual.如果一個人在一次登錄受控系統(tǒng)后的連續(xù)時長內(nèi)執(zhí)行一系列簽名時，第一個簽名應(yīng)使用所有的電子簽名要件來執(zhí)行，后續(xù)的簽名應(yīng)使用至少一個電子簽名要件來執(zhí)行。該要件只能由指定的人來執(zhí)行。(ii) When an individual executes one or more signings not performed dur