AUDITTrak, a TrakSYS module, is designed to provide electronic records and electronic signatures for all changes made to the production-related data in compliance with the Food and Drug Administration (FDA) 21 CFR Part 11. This module empowers pharmaceutical companies to undertake operational excellence initiatives with complete confidence in their data change management capabilities. The new AUDITTrak module for TrakSYS actively monitors and alerts changes to the existing infrastructure configuration, setpoints, products, and recorded values. Such changes trigger alerts and the need for authorization via multi-layer electronic signatures. Whenever a change is made, AUDITTrak mandates verification from two sources in the form of electronic signatures along with relevant notes to describe the reason for the change. All changes are recorded for detailed reporting and analysis. Authorized users can query and filter audit trails for reporting via the TrakSYS knowledge management portal, WEBTrak™.

Booth No. 2961