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Sparta Systems Inc.

FDA Compliance

Sparta Systems Readies Leading Organizations for eMDR

Leverage TrackWise enterprise quality management solution for proactive compliance with forthcoming regulation.

Published: Wednesday, March 10, 2010 - 11:49

(Sparta Systems: Holmdel, NJ) -- Sparta Systems Inc., the maker of TrackWise software and a provider of enterprise quality and compliance management solutions, has announced that a significant percentage of medical device companies currently submitting “high-volume” reports, leverage its TrackWise enterprise quality management solution for automated report submission to the FDA. These early adopters have taken proactive steps to comply with the electronic Medical Device Reports (eMDR) guidance, accelerating their realization of significant operational efficiencies and hard dollar savings over the manual, paper-based methods of the past.

The proposed eMDR regulation would require medical device companies to submit adverse event reports to the FDA’s Center for Devices and Radiological Health (CDRH) via an electronic gateway. In November of 2009, the agency closed the period for companies to submit comments on the proposed requirement, and industry experts expect the rule to become mandatory within 12 months, leaving little time for device makers to prepare for automated report submission. Many medical device companies have not yet been proactive in implementing an electronic submission system, while those that have done so have already realized demonstrable improvements in operational efficiencies and significant cost savings while preparing for compliance with the looming mandate.

TrackWise software automates the eMDR submission process for device manufacturers in the high-volume category, enabling successful reporting to CDRH in a fraction of the time previously spent on manual, paper-based submissions. Sparta has worked with a large percentage of the companies currently using eMDR to successfully plan, design, implement and test their TrackWise-enabled eMDR system, helping ensure that reports are submitted and acknowledgements received quickly and efficiently. Alternatively, companies can manually submit these electronic reports—an option that is resource-intensive for large organizations.

“Companies that leverage the TrackWise solution for eMDR compliance have demonstrated that they realize the time-sensitive nature of preparing for electronic submission,” says Mike Jovanis, vice president of product management for Sparta Systems. “With the deadline for compliance approaching and the opportunity for significant ROI apparent, it is crucial that more device makers recognize this need and take the necessary proactive steps to comply with this long-anticipated mandate.”

To learn more about the TrackWise solution for eMDR compliance, click here.


About The Author

Sparta Systems Inc.’s picture

Sparta Systems Inc.

Founded in 1994, Sparta Systems Inc. is the leading provider of enterprise quality management software. In addition to its U.S. operations, the company provides sales and services to Europe, Asia, and Australia through its subsidiary, Sparta Systems Europe Ltd.

Visit www.spartasystems.com.