We're in the process of moving from paper based document control to electronic. In looking at Part 11 compliance, Subpart B, Section 11.50 (a) states:
Signed electronic records shall contain information associated with the signing that clearly indicates all of the following:
(1) The printed name of the signer;
(2) The date and time when the signature was executed; and
(3) The meaning (such as review, approval, responsibility, or authorship) associated with the signature.
My question is on (3): is it sufficient that the electronic record shows, for example, that John Doe "approved" the document or is it required that his role or job title is also included on the record?
Signed electronic records shall contain information associated with the signing that clearly indicates all of the following:
(1) The printed name of the signer;
(2) The date and time when the signature was executed; and
(3) The meaning (such as review, approval, responsibility, or authorship) associated with the signature.
My question is on (3): is it sufficient that the electronic record shows, for example, that John Doe "approved" the document or is it required that his role or job title is also included on the record?