|
The Compliance Support Option for Insight® provides functionality for detailed tracking of modifications and deletions of supervised objects. With this option, you can track which property of an object was changed, its value before and after the change, who made the change, why the change was made, who authorized the change, and from where the change was made. This provides functionality to support customers that are required to comply with the Food and Drug Administration (FDA) regulations for Electronic Records, or 21 CFR Part 11.
Main Features of the Compliance Support Option are:
- Supervised Objects (points, PPCL, Trend Collection Reports, user accounts)
- Enhanced Operator Action Logging and Audit Trails via System Activity Log
For details on the Compliance Support Option for Insight, go to the Product Catalog and view the Technical Specification Sheet.
|