CGA M-16:2022現行
Standard for Food, Drug, and Medical Device Gas and Gas Equipment Manufacturers on Electronic Records and Signatures
出版：Compressed Gas Association
專家解讀視頻
基本信息
標準編號： CGA M-16:2022
標準類別：Standard
出版單位：Compressed Gas Association
標準頁數：0
標準簡介
This publication is based on FDA’s August 2003 Guidance for Industry Part 11, Electronic Records; Electronic Signatures—Scope and Application and satisfies the criteria of 21 CFR Part 11, § 11.1 (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”.
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