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FDA 21 CFR Part 11 – What Every Business Must Know?

VISTA InfoSec

In simple terms, 21 CFR Part 11 ensures that digital records and signatures are just as legally valid as handwritten ones. Key aspects of 21 CFR Part 11 include: Electronic Records: Ensures data is accurate, complete, and cannot be altered without proper authorization. This includes audit trails that record who made changes and when.

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