联邦法规：21CFR Part11“电子数据,电子签名,审计追踪” 中英对照

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PART 11Electronic Records; Electronic Signatures 11 第款 电子记录；电子签名 Subpart A--General Provisions A 分章一般规定 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. FDA 本条款的规则提供了标准，在此标准之下将认为电子记录、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. FDA 本条款适用于在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 FDAFDA 给的电子记录，即使该记录没有在规则下明确识别。 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) 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. FDA 一旦电子签名和与它相关的电子记录符合本条款的要求，将会认为电子签名等同于完全 FDA1997820 手签名、缩写签名、和其他的规则所求的一般签名。除非被从年月日起（包 括该日）生效后的规则明确地排除在外。