来源： Julia法规翻译
21 CFR 11.1 范围 20160527
§11.1 Scope.
范围
(a) The regulations in this part set forth thecriteria under which the agency considers electronic records, electronicsignatures, and handwritten signatures executed to electronic records to betrustworthy, reliable, and generally equivalent to paper records andhandwritten 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。
(b) This part applies to records in electronic formthat are created, modified, maintained, archived, retrieved, or transmitted,under any records requirements set forth in agency regulations. This part alsoapplies to electronic records submitted to the agency under requirements of theFederal Food, Drug, and Cosmetic Act and the Public Health Service Act, even ifsuch records are not specifically identified in agency regulations. However,this part does not apply to paper records that are, or have been, transmittedby 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。
(c) Whereelectronic signatures and their associated electronic records meet the requirementsof this part, the agency will consider the electronic signatures to beequivalent to full handwritten signatures, initials, and other general signingsas required by agency regulations, unless specifically excepted byregulation(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签名、首字母签名、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。
(d) Electronic records that meet the requirements ofthis 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。
(e) Computersystems (including hardware and software), controls, and attendantdocumentation maintained under this part shall be readily available for, andsubject to, FDA inspection.
依本部分要求维护的计算机系统（包括硬件和软件）、控制权、和随附的文件在
FDA
检查期间应可以提供。
(f) This part does not apply to records required to beestablished or maintained by §§1.326 through 1.368 of this chapter. Recordsthat satisfy the requirements of part 1, subpart J of this chapter, but thatalso are required under other applicable statutory provisions or regulations,remain subject to this part.
这部分内容不适用于根据本章
§§1.326
至
§§1.368
要求而建立或维护的记录。本章
§§1.326
至
§§1.368
所要求的记录，如其它适用法律法规条款也需要，则仍须符合本部分要求。
(g) This partdoes not apply to electronic signatures obtained under §101.11(d) of thischapter.
本部分不适用于依本章
§101.11(d)
所获得的电子签名。
(h) This part does not apply to electronic signaturesobtained under §101.8(d) of this chapter.
本部分不适用于依本章
§101.8(d)
所获得的电子签名。
(i) This part does not apply to records required to beestablished or maintained by part 117 of this chapter. Records that satisfy therequirements of part 117 of this chapter, but that also are required underother applicable statutory provisions or regulations, remain subject to thispart.
本部分不适用于根据本章第
117
部分要求而建立和保存的记录。本章第
117
部分所要求的记录，如其它适用法律法规条款也需要，则仍须符合本部分要求。
(j) This part does not apply to records required to beestablished or maintained by part 507 of this chapter. Records that satisfy therequirements of part 507 of this chapter, but that also are required underother applicable statutory provisions or regulations, remain subject to thispart.
本部分不适用于根据本章第
507
部分要求而建立和保存的记录。本章第
507
部分所要求的记录，如其它适用法律法规条款也需要，则仍须符合本部分要求。
(k) This part does not apply to records required to beestablished or maintained by part 112 of this chapter. Records that satisfy therequirements of part 112 of this chapter, but that also are required underother applicable statutory provisions or regulations, remain subject to thispart.
本部分不适用于根据本章第
112
部分要求而建立和保存的记录。本章第
112
部分所要求的记录，如其它适用法律法规条款也需要，则仍须符合本部分要求。
(l) This part does not apply to records required to beestablished or maintained by subpart L of part 1 of this chapter. Records thatsatisfy the requirements of subpart L of part 1 of this chapter, but that alsoare required under other applicable statutory provisions or regulations, remainsubject to this part.
本部分不适用于根据本章第
1
部分第
L
子部要求而建立和保存的记录。本章第
1
部分第
L
子部所要求的记录，如其它适用法律法规条款也需要，则仍须符合本部分要求。
(m) This part does not apply to records required to beestablished or maintained by subpart M of part 1 of this chapter. Records thatsatisfy the requirements of subpart M of part 1 of this chapter, but that alsoare required under other applicable statutory provisions or regulations, remainsubject to this part.
本部分不适用于根据本章第
1
部分第
M
子部要求而建立和保存的记录。本章第
1
部分第
M
子部所要求的记录，如其它适用法律法规条款也需要，则仍须符合本部分要求。
(n) This part does not apply to records required to beestablished or maintained by subpart O of part 1 of this chapter. Records thatsatisfy the requirements of subpart O of part 1 of this chapter, but that alsoare required under other applicable statutory provisions or regulations, remainsubject to this part.
本部分不适用于根据本章第
1
部分第
O
子部要求而建立和保存的记录。本章第
1
