Is the FDA planning to drop Part 11 requirements for electronic records?

Question

There was a discussion about whether the FDA is considering dropping Part 11 requirements for electronic records. The question was raised because the FDA's proposal mentions allowing electronic records and signatures, focusing on meeting the substance of requirements rather than the physicality of the record or signature methodology. However, it is unclear if this means Part 11 could be dropped, or if this is just a hopeful interpretation.
Is the FDA planning to drop Part 11, or is this more of a hope based on the language in their proposal?

Dr. Oliver Eidel · Accepted Answer

I'm not saying that the FDA is dropping Part 11, it's more of a hope based on the phrasing in their proposal. The key section says that manufacturers can use electronic records and methods for signing and dating if it best suits their business. The FDA states their focus is on whether the substance of requirements is met, not on the format or method of signature.
So far, there's no official statement that Part 11 is being dropped—just some language that leaves the door open for more flexibility. It's best to keep an eye on future updates from the FDA for anything official.

Is the FDA planning to drop Part 11 requirements for electronic records?

1 Answer

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