Q&A Draft Draft
Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations — Questions and Answers
ABSTRACT — EDITORS' SUMMARY
Draft Q&A on electronic systems in clinical investigations. Covers validation expectations, audit trails, hybrid systems, and cloud-hosted platforms. Companion to 21 CFR Part 11.
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PDF · CANONICAL LINK https://www.fda.gov/media/166215/download ↗ RELATED · SAME AUTHORITY