Bioequivalence and Bioavailability Forum

Well, like any questions about 21 CFR Part 11, the answer is 'it depends !'

In general I believe that the notification described by 11.100(c) is meant to be sent once by each company. It basically say's 'Yes, we understand what Part 11 entails, and we've started doing it'. So, yes, if you're company is planning to record signatures electroncially, then you need to notify the FDA of this.

The other main point about your question, is whether what you are referring to as a 'signature' in NuGenesis is actually an 'electronic signature according to the predicate regulations'. Many times in regulated industry when working on paper, we sign things. Often as a way to identify that some person took some action at some time, however only a few of these are actually described in the predicate regulations (such as GLP 21 CFR Part 58). Things like the study director 'signing' the Study plan are descibed as signatures. Other actions like someone checking analytical lab results require identification, but not nessarily a signature. On paper we could use initials, but often electronically we only have the electronic signature functionality.

This means that while you might think of something as a signature, and the NuGenesis software implents technology around electornic signatures, in the eyes or the regulator it is not an 'electronic signature' but an identification. This might mean you don't need to use an electornic signature because the audit trail provides the identification, or you might use the esignature process, but you don't need to apply the full force of Part 11 to it.

Just my 2 cents.

Paul.