Paperless trail: Parsec automation unveils electronic audit solution
By Manufacturing Business Technology Staff -- Manufacturing Business Technology, 2/29/2008 11:20:00 AM
Parsec Automation Corp., a supplier of real-time performance management solutions, has released a new application that can create electronic records and signatures for all changes made to the production-related data.
The solution—called AUDITTrak—will ensure a company’s compliance with the Food and Drug Administration (FDA) 21 CFR Part 11. AUDITTrak is a new module within Parsec’s TrakSYS software suite.
TrakSYS is a continuous improvement and knowledge management solution that helps pharmaceutical, medical device, biotech, and food & beverage manufacturers with the implementation of process analytical technology (PAT) framework—a set of FDA guidelines for addressing product quality and plant performance by using technology to manage and monitor manufacturing processes.
The new AUDITTrak module should allow pharmaceutical companies to undertake operational excellence initiatives with complete confidence in their data change management capabilities. AUDITTrak actively monitors for changes to the existing infrastructure configuration, set points, 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 also can query and filter audit trails for reporting via the TrakSYS knowledge management portal, known as WEBTrak.
“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 impact current good manufacturing practices,” says Scott Klages, VP and senior manufacturing consultant, Parsec Automation. “Parsec’s AUDITTrak provides users with full electronic record-keeping capabilities both for the collected data, and the data collection configuration.”
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