Part 11 Certified to legally binding of hand written signatures

L

lisawxf80

Involved In Discussions
My company is implementing Part 11, for the requirement of clause of 11.100c, persons using electronic signature, shall be cerified for legally binding equivalent of traditional handwritten signatures. is there a requirement for this re-certification on annual basis.

As we are seeing some of the company ask their employee to sign an agreement or training on annual basis.
 
sagai

sagai

Quite Involved in Discussions
I do not think so as long as the electronic signature system remains validated for its purpose.
Regards
Szabolcs
 
S

stacig

As long as the electronic system has been validated for electronic signatures (i.e. traceability, time stamped, access controlled, etc.) and you have the physical signatures on file for any documents that are signed outside of the system, then you are fine.

One thing to note, if someone signs documents in various different ways... Than those various signatures or initials need to be on file as well.
 
Y

yodon

Leader
Super Moderator
I think this is a largely-overlooked aspect of the regulation. Most companies I've talked to haven't filed anything with the FDA certifying their employees' e-signatures are the legally binding equivalent. As the regulation is written, it would seem that anytime you add a new employee that has to e-sign, another certification would be filed. There's nothing, though, that would indicate any re-certification is required (and I believe that's completely irrespective of the tool or validation status, by the way).

Might be a good survey topic for the community: how many companies using e-sigs have filed anything with the FDA certifying that the e-sig is equivalent to a hand-written signature.
 
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