The EMEA has completed implementation of Sparta Systems’ TrackWise software to support its integrated quality management (IQM) system. TrackWise is a 21 CFR Part 11 compliant, web-based tracking software tool for electronically logging, managing, and trending quality and regulatory issues and action items. The software centralizes quality processes into an integrated system, helping organizations increase efficiencies and achieve compliance by linking and consolidating related events and actions, automating workflow, and facilitating trending and reporting across quality systems and related organizational areas.

The EMEA implemented TrackWise to electronically manage critical quality-related processes including Audit Management, Audit Observations Tracking, Action Item Tracking and management of Standard Operating Procedures. TrackWise replaced paper-based and Microsoft Excel-based systems previously used by the agency. Also, the EMEA plans to deploy TrackWise to manage global risk management analysis and other activities related to the IQM system.

“We are proud to have the EMEA in production with TrackWise,” said Yaniv Vardi, vice president, operations of Sparta Systems Europe. “The four-month implementation is a testament to the collaborative relationship between Sparta Systems and the EMEA, as well as to the flexibility and performance of TrackWise. We are excited that the EMEA is already reaping the benefits of its investment.”

“We are pleased with the quick and smooth implementation and the overall breadth of the TrackWise solution,” stated Claus Christiansen, integrated quality management auditor of the EMEA.