21 CFR Part 11 Biometrics for electronic signatures


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I am in a unique situation in implementing CFR Part 11 and had an interesting idea regarding Biometrics.

My question is - Has anyone out there used a fingerprint scanner type application (biometrics) for electronic signatures or is this a rabbit hole I don't want to go down? If you have personal experience or advice I would appreciate it. Im asking myself if biometrics is more useful in a large-scale application or for our situation (5 people in different states - see below)

Some background so you understand the unique situation I am in. We are a company of 5 people, almost each in a different state - especially when it comes to those that will be creating/approving records. Yes, wow.

Thanks in advance


Super Moderator
No personal experience using biometrics is less complex (in terms of how much text is dedicated to it in the reg) than non-biometric e-sigs. The only thing in the reg is that biometrics are designed such that they cannot be used by anyone other than the owner. As long as the system records who and when, it might well be easier.


Involved In Discussions
Ok thanks, I might just set this up and give it a try. It doesn't sound like a lot of folks are trying this, especially in similar circumstances as mine. I will try to post up how it goes if this is the direction we take. Hopefully it will act as an aid to someone else considering doing this.
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