Audit Trails Overview

LHC creates two types of audit trails, System and Protocol. This happens behind the scenes. As users create, modify, save, and run protocols, the LHC logs each event, and its date and time. LHC Secure also records user login and logout, who performed the event, and administrative tasks, like managing a user account, signing an audit trail, and so on.

LHC provides tools for viewing, reporting, and exporting the audit trail to Excel and PDF.

Sample Audit Trail Records

LHC Secure users can be prompted to enter a comment for every audit trail event. LHC does not capture the specific details of a change; it only recognizes that a change or event has occurred. Requiring your users to write a full description of the changes they made or the event they initiated may be the best method of change tracking. Users' comments are stored and reported with the audit trail. Because user information is retained permanently in the audit trail records, you may also want to permanently retain all user accounts, i.e., instead of deleting a terminated user's account, change its status to Locked (not Active).

System Audit Trail

The system audit trail records all LHC and instrument related events. See Audit Trail Events for a complete listing. The system audit trail is stored in the database. LHC administrators are encouraged to develop a good practice for maintaining the database, including regular backups.

Protocol Audit Trail

The protocol audit trail logs two types of events, signatures and protocol "saves," it logs an event each time the protocol file is saved. Each protocol has its own protocol audit trail embedded in the protocol file. Whenever the protocol is distributed, its audit trail accompanies it. This permits regular LHC and LHC Secure users to share protocol files seamlessly.

In addition to the audit trail, LHC Secure offers a Protocol History feature that saves a copy of every protocol revision. This feature permits a detailed evaluation of the changes made to a protocol over its lifetime.