System Level Audits allows users to track system level actions to an audit trail for further improving compliance with regulatory requirements such as 21 CFR Part 11.

 

The System Levels Audits feature is only available when the Logging/Audit Trail add-on has been purchased/enabled.

 

To enable System Level Audits, go to File tab→Security→Edit Security Configuration→System Level Audits and check the Enable System Level Audits check box (Figure 18.31).

 

When Enable System Level Audits is checked, a second check box, named Require a Reason for Change, will be available. When the Require a Reason for Change check box is activated, the user will be prompted to insert a reason for change to justify that specific action when a system level event is changed. For more information on System Level Audits, for a full list of audited actions, and a full list of actions that can be set to require a reason for change, please refer to the All System Level Audits Report chapter.

 

Please note - System Level Audits are only available for customers who purchase our Security and Logging options.