Warning Letter Citing Part 11 Reveals FDA's Enforcement Position, Experts Say

Drug Industry Daily
KEYWORDS FDA / Part 11 / Warning
A A

A recent warning letter citing 21 CFR Part 11 validation and control requirements is a clear signal that the FDA will enforce the electronic records and signatures regulation even as the agency moves toward revising it, industry experts say.

To View This Article:

Login

Subscribe To Drug Industry Daily