In a gmp computerized system, does the audit trail required to capture user logins? I’ve just encountered a system which comes equipped with an audit trail. While the audit trail captures records including time/date/user when the system start/stop/abort or when changes are made to setpoints, user roles, etc., however, it does not capture the login if the user does not perform any such executions. Is this acceptable as far as compliance to 21 CFR Part 11?
I’m used to seeing systems where anytime a user access the system, a record is created.
Any insight is appreciated.