As defined in the FDA guidance, an audit trail is a secure, computer-generated, time-stamped electronic record that allows for reconstruction of the events relating to the creation, modification, or deletion of an electronic record. An audit trail is a chronology of the “who, what, when and why” of a record.
An EQMS automatically tracks all changes. This includes remembering the old field values, date and time of the change, the name of the person who made the change and the reason for the change. This makes the necessary information readily available for the audit trail.
