21 CFR 11-电子记录及电子签名.docxVIP

Title 21?→?Chapter I→?Subchapter A?→Part11TITLE 21—Food and Drugs食品和药品CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTHAND HUMAN SERVICES?食品药品管理局，卫生福利部SUBCHAPTER A—GENERAL通则PART 11—ELECTRONIC RECORDS; ELECTRONIC SIGNATURES电子记录，电子签名Sec. 11.1 Scope.范围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.本部分的规定设定了FDA认为电子记录、电子签名和对电子记录所实施的手写签名可靠可信，并且通常等同于纸质记录和在纸上手书签名的标准。 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.本部分适用于依FDA法规中设定的记录要求创建、修改、维护、归档、检索或传送的电子形式记录。本部分也适用于依《联邦食品药品化妆品法案》和《公众健康服务法案》要求提交给FDA的电子记录，即使此记录未在FDA法规中明确被识别。但是，此部分不适用于将采用或已采用电子方式传输的纸质记录。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.如果电子签名和与它相关的电子记录符合本部分的要求，FDA将会认为电子签名等同于完全手写签名、缩写签名和其他的FDA法规所求的一般签名，1997年8月20日之后生效的法规明确排除者除外。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.除特别要求使用纸质记录者外，依据§11.2，符合本部分要求的电子记录可用以替代纸质记录。Computer systems (including