Q: When signing a record, there is a box to select the meaning of the signature. What is this?

A: The meaning of the signature selection field was added at the request of an FDA auditor. The FDA requires that electronic signatures include a field for the meaning of the signature. Here is the excerpt from 21 CFR Part 11:

21CFR11 Part 11
Subpart B--Electronic Records
Sec. 11.50 Signature manifestations.
(a) 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.

For TRAIN TRACK, when taking an exam, the meaning of the signature will be Authorship, meaning that the person who is adding the signature is the person who created the record or took the exam, i.e. the author of the record.

The only time another meaning besides authorship might be selected would be when an administrator user adds a signature to a record from the training detail screen, indicating that they have reviewed or approved the record, but they were not the author of the record.

Tags: completion records, electronic signature.