The Food and Drug Administration (FDA) has published guidance for compliance with specific regulations in 21 CFR Part 11. This guidance is intended to describe the FDA’s current thinking regarding the scope and application of part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures (21 CFR Part 11).
April 17, 2025
April 11, 2025
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March 28, 2025
March 21, 2025
