Electronic auditing for 21-CFR-Part-11

This software module manages electronic records and signatures in compliance with Food and Drug Administration regulations.

By Plant Engineering Staff November 25, 2008

AUDITTrak is a new software module for TrakSYS 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 21-CFR-Part-11. The module empowers pharmaceutical companies to undertake operational excellence initiatives with complete confidence in their data change management capabilities.

The module provides full electronic record-keeping capabilities both for the collected data, and the data collection configuration. It 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.

Parsec Automation Corp.