A signed document is not always a defensible one. When a transaction carries legal, financial, or operational risk, the real question is not just whether someone signed, but whether you can prove who signed, how that person was authenticated, and what evidence remains if the transaction is challenged.
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).
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