Electronic Signatures: When to Notify the FDA

Q: Does my company need FDA approval to start using electronic signatures?

A:  No, but you do need to notify FDA of your intentions.

Under 21 CFR Part 11.100 (c), you must certify to FDA that your personnel understand that their electronic signatures are equivalent to their handwritten signatures. Contrary to what some companies may fear, your notification will NOT trigger an immediate inspection. But the FDA is likely to look at your implementation of electronic signatures during future inspections of your company.

Answered by Janis Olson, EduQuest’s Vice President of Regulatory and Quality Services, who worked at the U.S. FDA as an expert field investigator and a regional director of information management resources for 22 years. Janis also is a developer and co-instructor for EduQuest’s popular FDA Auditing of Computerized Systems and Part 11/Annex 11 three-day training class.

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