AUDITTrak™ Pharmaceutical Manufacturing Software Addresses the Need for Electronic Records and Signatures in Compliance with FDA 21 CFR Part 11

Groundbreaking pharmaceutical manufacturing software allows
efficient implementation of LEAN manufacturing in pharma.

AUDITTrak™ is a groundbreaking new TrakSYS™ module, 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 Document Management Standards.

This pharmaceutical manufacturing software module empowers pharma companies to undertake operational excellence initiatives with complete confidence in their data change management capabilities.

The new AUDITTrak™ module for TrakSYS™ actively monitors changes to the existing infrastructure configuration, setpoints, products, and recorded values. Such changes trigger notifications for the needed 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™.

Electronic signatures ensure compliance with
FDA 21 CFR Part 11

AUDITTrak™ features and benefits:

• Complete implementations in compliance with FDA 21 CFR Part 11 document management standards
• No changes to current infrastructure required
• Does not affect validation
• Allows for single or double electronic signature validation
• Captures and reports modification details
• Used with other TrakSYS™ modules, AUDITTrak™ measurably improves asset utilization and productivity with proven ROI

Download the AUDITTrak™ Brochure or Contact Us now to learn more.