Press Releases

  • Sparta Systems Announces Software for Electronic Submission of Medical Device Reports to Food and Drug Administration (FDA)

    Holmdel, NJ - February 20, 2007 – Sparta Systems, Inc., (Sparta), the maker of TrackWise®, and the market leader in enterprise quality and compliance process management software, today announced that it has released the Beta version of the TrackWise eMDR Submission Manager™ software. The add-on software enables medical device companies to electronically submit Medical Device Reports (MDRs) to Food and Drug Administration (FDA). TrackWise eMDR Submission Manager™ is one component of Sparta's current initiative to support the growing number of life sciences electronic submission processes, which are complementary to quality and regulatory solutions.

    Medical device manufacturers use TrackWise to electronically track and manage product complaint and adverse event assessment and reporting processes. The software enables device companies to effectively manage complaints and investigations, assess potential adverse events for safety risk problems, and comply with health authority reporting requirements, including those of FDA.

    FDA regulations require firms who have received complaints of device malfunctions, serious injuries, or deaths associated with medical devices to notify FDA of the incident. Manufacturers are required to submit an individual adverse event report (known as a "MDR Report") to FDA using its 3500A form. TrackWise customers currently produce 3500A reports in electronic form, from structured audit-trailed data fields. Sparta's 3500A report has been previously approved by both FDA's Center for Devices and Radiological Health (CDRH) and Center for Drug Evaluation and Research (CDER).

    In an effort to streamline reporting of 3500A reports, FDA is now implementing an electronic submission program called "eMDR." Under this program, FDA receives electronic submissions of MDRs via the FDA Gateway, a secure agency-wide entry point for all electronic submissions. Using this approach, medical device manufacturers can issue their reports electronically, eliminating costs and errors associated with paper-based reporting processes.

    Sparta was asked by FDA to participate in its eMDR pilot program. Collaborating closely with the agency, Sparta has developed standard functionality within TrackWise that allows customers to electronically transmit MDRs through the FDA's Secure Gateway.

    "FDA's eMDR Program and the TrackWise eMDR Submission Manager enable our medical device customers to improve their adverse event reporting processes by eliminating paper forms and manual document routing," stated Mike Jovanis, Director, Solutions Architecture of Sparta. "TrackWise increases efficiency while approving accuracy of information, providing a better and more effective product safety process, which ultimately benefits consumers and patients."

    The new functionality, TrackWise eMDR Submission Manager can be added to both existing and new TrackWise deployments. Several of Sparta's larger device clients are already working with Beta versions of the functionality, and are planning to begin submitting MDRs electronically upon completion of the beta program.


    About Sparta Systems

    Founded in 1994, Sparta Systems is the world’s premier provider of cloud and on-premise quality management software. We offer the solutions, analytics, and expertise that speed up quality and compliance. Our solutions help to lower risk, increase efficiency, and keep consumers safe while allowing manufacturers, suppliers, and distributors to collaborate in a seamless and integrated environment. Sparta is privately owned and headquartered in Hamilton N.J, with offices across Europe and Asia. We support close to 1 million users across 700+ implementations, in more than 30 countries. Companies in life sciences, consumer products, discrete manufacturing and more, rely on Sparta.

 
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