FDA CDERの2022年度発出予定のガイダンスリストにおいて、「Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and …
本ガイダンスは、2017年にドラフトガイダンスが発出されていた。これがファイナライズされるものと思われる。
Use-of-Electronic-Records-and-Electronic-Signatures-in-Clinical-Investigations-Under-21-CFR-Part-11-–ダウンロード
]]>
Related Articles
- FDA Finalizes Comprehensive Guidance on Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations
- Correct Understanding of Electronic Signatures under 21 CFR Part 11
- Electronic Documents Requiring Electronic Signatures: Understanding FDA Part 11 and Japan’s ER/ES Guidelines
- The Evolution of Electronic Records Regulations: From FDA Part 11’s Tumultuous Past to Today’s Global Harmonization
- Understanding Legibility: A Fundamental Requirement for Electronic Records
- Understanding Electronic Signatures: A Comprehensive Guide
Aw, this was a very good post. Finding the time and actual effort to
generate a great article… but what can I say… I hesitate a whole lot and
don’t manage to get nearly anything done.