How electronic should the offices of regulatory agencies be? On the one hand, they’re accustomed to paper. They have no legal mandate to require electronic submissions, only the ability to gently encourage the industry to move toward electronic systems. The FDA is certainly doing that. But as the FDA’s own presentations at industry conferences suggest, some companies are very much submitting data electronically—and others are not.

Now a New Jersey company, Sparta Systems, says that its tools are being used by the European Medicines Agency (EMEA). The press release from the company said:

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. With its ability to centralize quality processes into a single, integrated system, TrackWise helps 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 implementation of TrackWise at the EMEA was completed in only four months, meeting all project timelines and budget goals. 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 numerous paper-based and Microsoft Excel-based systems that were previously used by the agency.

Based on its success with the initial implementation, the EMEA now plans to further 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, Ltd. “The four month implementation is a testament to the collaborative, success-oriented working 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.”