When are e-Signatures Required?

We answer a lot of questions submitted to us by e-mail or in various on-line groups. We thought that some of these deserve a wider audience, so from now on we're going to publish the best questions (and answers) here on the Life Sciences Blog.

Q. I had a question regarding 21 CFR Part 11 Electronic records. If a system has electronic records but no electronic signature but does contain the Audit trail does it mean that each record that is created within the system has to be printed in hard copy and signed so as to associate that record with the signature.

A. The fact the system has an Audit trail which links the user name and action on that records is sufficient enough to meet the 21 CFR Electronic Records criteria. If the record requires no signature (either explicit or implied from a predicate rule perspective) then there is no need to print and sign anything (either copies of the record or the audit trail).

The (secure) recording of what, (optionally who) and why (inferred from the transaction) will be sufficient to demonstrate compliance with the predicate rule.

A good example would be a training record. The predicate rule does not require training records to be signed, but you would still want to record what (training was undertaken), who (who was trained) and why (the training topic or syllabus). Even though an audit trail would be maintained for the training record, there would be no need to print and sign it because the predicate rule requires no signature.