内容提示: Guidance for Industry Part 11, Electronic Records; Electronic Signatures August 2003Page 1 of 13Guidance for IndustryPart 11, Electronic Records; Electronic Signatures— Scope andApplicationAugust 2003Pharmaceutical CGMPsFDA 工业指南联邦法规 11 分 部分 电子记录和电子签名— 范围和应用2003 年 8...
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Here I will give an overview of FDA 21 CFR Part 11, which has been an important topic in the pharmaceutical industry for several years, and consider its observance in the field of FTIR. ■ FDA 21 CFR Part 11 FDA 21 CFR Part 11 ...
美国FDA 指导原则 符合21 CFR第4部分工业指南的某些眼科产品政策 英文原版.pdf,Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4 Guidance for Industry This guidance is for immediate implementation. FDA is issuing this guidance for i
最新-21-CFR-PART-11-企业指南---中英对照[1]Guidance for Industry Part 11,Electronic Records;Electronic Signatures August 2003 Page 1of 13Guidance for Industry Part 11,Electronic Records;Electronic Signatures —Scope and Application August 2003Pharmaceutical CGMPs FDA 工业指南联邦法规11部分电子记录和电子...
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内容提示: Guidance for Industry Part 11, Electronic Records; Electronic Signatures — Scope and Application August 2003 Pharmaceutical CGMPs FDA 工业指南 规 联邦法规 11 部分 电子记录和电子签名 — 范围和应用 2003 年 8 月 药物 CGMPs TABLE OF CONTENTS 目录 I. Introduction ... 2II. Background .....
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