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2012-12-07 19:22:12

与美国小学生一起学英文第11册(mp3 中英字幕) 第1期
与美国小学生一起学英文第11册(mp3 中英字幕) 第1期PART11中英中英中英文在线翻译part11

PART 11-ELECTRONIC RECORDS; ELECTRONIC SIGNATURES 第 11 款 电子记载;电子签名Subpart A —General Provisions 分章 A —— 平常规章11.1 Scope. 11.1 适用范围 11.2 Implementation. 11.2 实行 11.3 Definitions. 11.3 定义Subpart B—Electronic Records 分章 B —— 电子记载11.10 Controls for closed systems. 11.10 封锁系统的操作 11.30 Controls for open systems. 11.30 开放系统的操作 11.50 Signature manifestations. 11.50 签名的验证 11.70 Signature/record linking. 11.70 签名/记载衔接Subpart C—Electronic Signatures

分章 C —— 电子签名11.100 General requirements. 11.100 平常要求 11.200 Electronic signature components and controls. 11.200 电子签名的构成及操作 11.300 Controls for identification codes/passwords. 11.300 识别代码和密码的操作 Authority: Secs. 201-903 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321-393); sec. 351 of the Public Health Service Act (42 U.S.C 262). 援用:《联邦食物、药品和化装品法案》修订版第 21 章第 201-903 页;《公共安康服 务法案》修订版第 42 章第 351 页。

Subpart A—General Provisions 分章 A —— 平常规章§ 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. (a) 本条款的规章提供了尺度,在此尺度之下 FDA 感觉电子记载、电子签名,和在电 子记载上的手写签名是可信任的、牢靠的同时通常同等于纸制记载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 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.

(b) 本条款适用于在 FDA 规章中阐明的,在任何记载的要求下,以电子表格方式树立、 修正、维护、归档、检索或传送的记载。

本条款异样适用于在《联邦食物、药品和化装品 法案》和《大众安康效劳法案》要求下的呈送给 FDA 的电子记载,即使该记载没有在 FDA 规章下被明晓识别。

然而,本条款不适用于如今和曾经以电子的方式传送的纸制记载。

(c)Where electronic signatures and their 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. (c) 一旦电子签名和与它相关的电子记载合适本条款的要求,FDA 将会感觉电子签名完 全同等于手写签名、缩写签名、和其他的 FDA 规章所求的平常签名。

除非是被 1997 年 8 月 20 日起(包括该日)失效后的规章明晓地排遣在外的电子签名。

(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. (d) 依照本条款 11.2,除非纸制记载有特殊的要求,合适本条款要求的电子记载能够代 替纸制记载运用。

(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. (e) 在本条款下维护计算机系统(包括硬件和软件)、操作权、和随附的文件应便于被 FDA 用到、遵照于 FDA 的监管。

§ 11.2 Implementation. 11.2 实行(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. (a) 关于需求维护,但不提交给 FDA 的记载,假设合适本条款的要求,人们能够运用全 部或许部分的电子记载替代纸制记载,或用电子签名替代传统签名。

(b)For records submitted to the agency, persons may use electronic records in lieu of traditional signatures, in whole or in part, provided that: (b) 关于需求提交给 FDA 的电子记载,人们能够运用全部或部分电子记载替代纸制记 录或电子签名替代传统签名(手写签名)假设:

(1)The requirements of this part are met; and (1) 合适条款的要求;和 (2)The document or parts of a document to be submitted 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 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 electronic submission. (2) 提交的文件或部分文件,作为 FDA 以电子方式接纳的提交物的类型曾经被编号为 92S-0251 公共择要识别出来。

那个择要将明晓地识别出,何种类型文件或部分文件在没 有纸制记载和 FDA 接纳单位(举例来说,特定的中心、办公室、部门、分支机构)时的电子 方式提交物是可接纳的。

假设没有在公共择要上明晓出来,他们以电子方式提交给 FDA 接纳单位的文件将被感觉是不正式的;这种文件的书面方式将被感觉是正式的但务必伴有 电子记载。

人们希冀与未来的 FDA 接纳单位就详细的(举例来说,传送的办法、媒体、 文件格式和技术协议)怎么样停止和能否停止电子的提交物停止协商。

§ 11.3 Definitions. 11.3 定义(a)The definitions and interpretations of terms contained in section 201 of the act apply to those terms when used in this part. (a) 包括于法案 201 部分中术语的定义和翻译异样适用于那些在本条款中运用到的术语。

(b)The following definitions of terms also apply to this part: (b) 下列术语的定义异样适用于本条款 (1)Act means the Federal Food, Drug, and Cosmetic Act (secs. 201-903(21U.S.C. 321-393)). (1)法案是指联邦食物、药品、化装品法案 (2)Agency means the Food and Drug Administration. (2)机构是指美国食物和药品管理局(FDA)

(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 measureable. (3)生物测定学是指一种基于团体的身子特征及反复行径(这些特征和行径对团体来说 是唯独的和能够测量的)的测量来校验团体身份的办法。

(4)Closed system means an environment in which system access is controlled by person who is responsible for the content of electronic records that are on the system. (4)封锁系统是指一种环境,在此环境中系统的登录是被那些对系统上电子记载的内容 担负的人们所操作。

(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. (5)数字签名是指一种基于发信方鉴别加密的办法,以使签名者的身份运用一套规章和 一系列参数计算和校验数据的完整功能。

(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. (6)电子记载是指任何文本、图表、数据、声响、图示的或其他的以电子方式表现的信 息的混合,它的树立、修正、维护、归档、检索或分发是由计算机系统来完成的。

(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. (7)电子签名是指一种由一团体实行、采取或同意成为与其团体的手写签名具有相反的 法律效能的计算机数据的恣意符号或一系列符号的编译。

(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 writing in a permanent form. The act of signing with a writing of 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. (8)手写签名是指团体的手写笔迹的签名或合法的标志,以永久的方式书写真实意图所 采取的团体签名或合法标志。

用书写及标志工具(例如一支钢笔或尖笔)的签字行径是被

保管的。

手写签名或合法的标志当商定俗成地适用于书面上,也能够适用于其它的猎取名 字及标志的装备。

(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. (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载的内 容担负的人所操作。

Subpart B—Electronic Records 子分章 B—电子记载§ 11.10 Controls for closed systems. 11.10 封锁系统的管理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: 人们运用封锁系统来树立、修正、维保、或传送电子记载应该运用设计的能够保证记载真 实性、完整性和适当的隐秘性的次第和操作,以保证签名者不能随便地否认曾经签署的记 录是不真实的。

如此的次第和操作应包括如下: (a)Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records. (a) 系统的验证以保证准确、牢靠、动摇地预期功能,有才干识别有效的和被改变的记 录。

(b)The ability to generate accurate and complete copies of records in both human readable and electronic form is 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. (b) 确保发作人们易读的和合适 FDA 检验、回想、和拷贝的电子方式的准确的、完整 的记载的正本。

当人们不明白 FDA 实行如此的电子记载回想和拷贝的才干时,应该联络 FDA。

(c)Protection of records to enable their accurate and ready retrieval throughout the records retention period.

(c) 记载的保卫以使记载能够在整个的保管期内是准确的和易于检索的。

(d)Limiting system access to authorized individuals. (d) 经过授权团体用户以限制系统的登录。

(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. (e) 运用安全的、计算机发作的、时刻印记的审核跟踪以便独立地记载操作者登录和建 立、修正、或删除电子记载的行径的日期和时刻。

记载的改变不能使往日的记载信息被覆 盖。

如此的审核跟踪文档将至少被保管如此一段时刻,这取决于隶属于的电子记载在 FDA 复查和拷贝时保证是可失掉的。

(f)Use of operational system checks to enforce permitted sequencing of steps and events, as appropriate. (f) 必要时,运用操作系统检验以增加进程和情形的排序。

(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 operation at hand. (g) 运用验证检验以保证只好被授权用户才能够运用系统,以电子方式签署记载,运用 操作或计算机系统的输入输入装备,改变记载或手工实行操作。

(h)Use of device (e.g., terminal) checks to determine, as appropriate, the validity of the source of data input or operational instruction. (h) 必要时运用装备(举例来说,终端)检验以确定数据输入来源或操作指点的有效性。

(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. (i) 确定开垦、维护或运用电子记载/电子签名系统的人员应具有与他们被指使实行的任 务相应的教育、培训和经验。

(j)The establishment of, and adherence to, written policies that hold individuals accountable and responsible for actions signatures, in order to deter record and signature falsification. (j) 为了阻挠记载和签名的伪造,确立与坚持源自团体电子签名行径的责任与职责的书 面战略。

(k)Use of appropriate controls over systems documentation including: (k) 在系统文件方面运用适当的操作包括: (1)Adequate controls over the distribution of, access to, and use of documentation for system operation and maintenance. (1) 在分发的、有权运用、系统运转和维护方面运用的文件有足够的操作。

(2)Revision and change control procedures to maintain an audit trail that documents timesequenced development and modification of systems documentation. (2) 修订和改变操作次第以坚持一个以时刻顺序发作和修正的系统文件的审核跟踪。

§ 11.30 Controls for open systems. 11.30 开放系统的管理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 indentified 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. 人们运用开放系统来树立、修正、坚持、或传送电子记载将运用设计次第和操作以保证电 子记载从他们的创立处到他们的接纳处的真实性、完整性和隐秘性。

这种次第和操作应包 括那些在 11.10 中被识别的,必要时附加的测量例如文档的加密术和运用适当的数字签名 尺度以保证,在此环境下,记载必要的准确性、完整性和隐秘性。

§ 11.50 Signature manifestations. 11.50 签名的显示(a)Signed electronic records shall contain information associated with the signing that clearly indicates all of the following: (a) 签署电子记载应包括能明晰显示如下全部与签名相关的信息: (1)The printed name of the signer; (1) 用印刷体书写出签名者的名字

(2)The date and time when the signature was executed; and (2) 签名失效的日期和时刻;和 (3)The meaning (such as review, approval, responsibility, or authorship) associated with the signature. (3)和签名相关的含义(例如回想、同意、职责、或原创作者) (b)The 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). (b)该条款已识别出在这一部分(a)(1),(a)(2),and(a)(3)节应遵照于和电子记载异样的操作 同时应该包括人们易读的电子记载的方式(例如电子显示或打印输入)§ 11.70 Signature/record linking. 11.70 签名/记载衔接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 transferred to falsify an electronic record by ordinary means. 在电子记载上签署的电子签名和手写签名应该链接到它们各自的电子记载以保证电子 签名不能够被删除、拷贝或许其他方面的转变致使于运用平常手法伪造一个电子记载。

Subpart C—Electronic Signatures 分章 C 电子签名§ 11.100 General requirements. 11.100 平常要求(a)Each electronic signature shall be unique to one individual and shall not be reused by, or reassigned to, anyone else. (a) 每一个电子签名应是唯独对应单独一团体的同时不能被再运用、或再安排给其他任 何人。

(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. (b) 在一个组织树立、安排、证实,或同意一团体的电子签名或其他的任何如此的电子 签名的要素前,组织将校验团体的身份。

(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 signatures. (c) 签名者运用电子签名前或运用时应向 FDA 证实,从 1997 年 8 月 20 日起及以来在 他们系统上的电子签名,与传统的手写签名有同等的法律效能。

(1)The certification shall be submitted in paper form and signed with a traditional handwritten signature, to the Office of Regional Operations (HFC-100), 5600 Fishers Lane, Rockville, MD 20857. (1) 证实要以书面方式提交到“中央运转办公室”并采取传统的手写签名, (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 signer’s handwritten signature. (2) 应 FDA 要求,人们在运用电子签名时应提供一份明晓电子签名与签字者手写签 名具有同等的法律效能的附加的证实书或凭证。

§ 11.200 Electronic signature components and controls. 11.200 电子签名的成分及管理(a)Electronic signatures that are not based upon biometrics shall: (a) 不依照生物测定学的电子签名应该: (1)Employ at least two distinct identification components such as an identification code and password. (1) 运用至少二种迥然不同的证实成分,例如识别码和密码。

(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 at least one electronic signature component that is only executable by, and designed to be used only by, the individual.

(i) 当一团体在一个独立的延续受控的系统登录时期内签署了一系列的签名,签署的 第一个签名将运用全部的电子签名成分。

后续签署的签名应运用至少一种的电子签名的成 分。

该成分只能由团体签署,同时设计只能由团体来运用。

(ii)When an individual executes one or more signings not performed during a single, continuous period of controlled system access, each signing shall be executed using all of the electronic signature components. (ii) 当一团体不在一个独立的延续受控的系统登录时期内签署一个或多个签名时,每 一个被他签署的签名应运用全部的电子签名成分。

(2)Be used only by their genuine owners; and (2) 仅供他们真正的全部者运用; (3)Be administered and executed to ensure that attempted use of an individual’s electronic signature by anyone other than its genuine owner requires collaboration of two or more individuals. (3) 管理和签署以确保任何除其真正全部者外的其他人尝试运用该电子签名时需求二 个或更多的人的协作。

(b)Electronic signatures based upon biometrics shall be designed to ensure that they cannot be used by anyone other than their genuine owners. (b)依照生物测定学的电子签名应被设计成能确保他们不能被真正全部者之外的其他 人运用。

§ 11.300 Controls for identification codes/passwords. 11.300 识别代码和密码的管理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: 人们运用基于应用识别码和密码混合的电子签名应增加管理以保证他们的安全和完整,这 种管理应包括: (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. (a) 坚持每一个识别码和密码结合的唯独性,也一定是不或许有二团体有相反的识别码和密 码。

(b)Ensuring the identification code and password issuances are periodically checked, recalled, or revised (e.g., to cover such events as password aging). (b) 保证识别码和密码发布能活期被检验、收回或是修订(举例来说,掩盖象密码过时 如此的情形)(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. (c) 依照损失管理进程对丧失、被盗、找不到或有损坏能够的记号、卡片及其他装置 (生成或创立识别码或口令信息的装置)停止电子失效,并运用适当、严厉的操作发行临 时或永久的代用品。

(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 any attempts at their unauthorized use to the system security unit, and, as appropriate, to organizational management. (d) 运用安全装置以预防未被授权的密码或识别码的运用,采取立即和紧急的措施检测 并报告任何试图未经授权运用安全系统的单位,以及适当的组织管理。

(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. (e) 最终来的和活期的装备测试,例如记号或卡片,包括或发作识别代码或密码信息,以 保证他们行使适当的职责和改变未被授权的行径。