SOURCE: Parsec Automation Corp.

February 28, 2008 14:03 ET

Parsec Introduces AUDITTrak™: Software Module for Managing Electronic Records and Signatures in Compliance With 21 CFR Part 11

BREA, CA--(Marketwire - February 28, 2008) - Parsec Automation Corp., developer of TrakSYS™ and a world leader of real-time performance management (RPM) solutions, announces the release of AUDITTrak. AUDITTrak, a new groundbreaking 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.

"In today's ever-changing world of compliance and regulatory standards, users of performance management systems must have the assurance that compliance with FDA regulations is preserved should changes to data have cGMP impact," says Scott Klages, VP and Sr. Manufacturing Consultant for Parsec. "Parsec's AUDITTrak provides users with full electronic record-keeping capabilities both for the collected data, and the data collection configuration."

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™.

About Parsec Automation Corp.

Parsec Automation Corp. is the developer of TrakSYS™, the leading real-time performance management (RPM) solution and enterprise manufacturing intelligence (EMI) software. TrakSYS is a powerful continuous improvement and knowledge management solution that helps pharmaceutical, medical device, biotech, and food & beverage manufacturers with the implementation of process analytical technology (PAT) -- a Food and Drug Administration regulatory framework -- to address product quality and performance through the timely analysis of manufacturing processes. More than 300 major companies worldwide rely on Parsec for flexible and configurable tools to quickly track, record, analyze and report the events critical to productivity enhancement. Without production disruption TrakSYS helps manufacturers to significantly improve asset utilization and efficiency, increase capacity with existing capital equipment, reduce production costs, and improve profitability. With measurable ROI TrakSYS™ fuels Lean, Six Sigma, TPM, and Operational Excellence efforts. For more information about Parsec please visit the corporate web site at

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