Sparta Systems(TM) Outlines Tips and Tactics to Prepare for eMDR Mandate

Suggested Best Practices will Prepare Medical Device Manufacturers to Comply
with Expected Legislation and Drive Continued Innovation of Critical
Healthcare Products

HOLMDEL, N.J., June 16 /PRNewswire/ -- Sparta Systems, Inc., the maker of
TrackWise(R) software and the market leader in enterprise quality and
compliance management solutions, today outlined its recommendations to help
companies prepare for electronic Medical Device Reporting (eMDR), the expected
regulation from FDA Center for Devices and Radiological Health (CDRH). The
mandate will require electronic filing of safety reports for medical device
organizations.

Understanding the daunting challenges presented to medical device companies in
transitioning to an electronic submission system, Sparta Systems has developed
a multi-step approach that organizations can employ to prepare for the eMDR
legislation in advance of the regulatory mandate. These strategies will arm
organizations for compliance with the legislation when eMDR reporting is
mandated, with tactics geared specifically toward thought, planning, design,
testing and, ultimately, implementation.

Sparta Systems has been in close communication with the FDA as the proposed
legislation has been refined, and proactively provides its customers with an
enterprise-wide quality management system that allows for a seamless
transition from the current paper-based system to an electronic submission
model. These suggestions for proactive eMDR compliance will not only help
reduce associated compliance costs, but should also serve to streamline
manufacturing processes, help ensure the safety of medical devices and foster
customer loyalty. These suggestions include:

1. Thought - Before any system can be designed, a thorough, candid
self-evaluation is required for companies to understand the scope and
nature of their businesses' eMDR needs. Initially considering these
vital questions will lay the foundation for a successful transition
before any planning or design has been implemented.
2. Planning - After the current MDR methodology has been reviewed and a
needs analysis conducted, the next step is to plan the transition from
the old system to the new one. During this review, common processes
should be leveraged and divergent processes isolated and documented.
At
the end, the actual method and means of receiving, transmitting and
auditing data will be critical.
3. Design - Design of an eMDR system should bring together all the
elements
discussed and reviewed throughout the thought and planning phases.
Designing an effective system that includes these elements working in
proper order and alignment will result in reduced time and costs spent
testing and, finally, implementing the final eMDR solution.
4. Testing - Once a system has been designed that will theoretically
satisfy
eMDR requirements, the next step is to test it. Possible failure
scenarios should also be tested to ensure that the appropriate action
takes place in the system when the failure is identified.

5. Implementation - Finally, when all the necessary steps have been
completed, and the system has been thoroughly tested, implementation
can
occur. Careful observation of eMDR users and approvers is important to
ascertain that they are adhering to correct procedures and that reports
are being submitted and filed in a timely manner.

"Whether organizations like it or not, eMDR is coming, and it is in the best
interest of companies of all sizes to begin their preparations for electronic
submission now, before they no longer have the option," said Mike Jovanis,
vice president of product management, Sparta Systems. "Sparta Systems is
committed to helping our customers ensure a smooth transition to this
electronic submission process, and the enhanced reporting functionality in our
TrackWise software can make this transition as simple and painless as
possible."

To learn more about eMDR and receive thorough preparation guidelines, click
here. For a complete overview of Sparta Systems and TrackWise software, visit
www.spartasystems.com.

Sparta Systems and TrackWise are trademarks or registered trademarks of Sparta
Systems, Inc. All other marks are trademarks of their respective companies.

Press Contact
Jon Rabinowitz
Sparta Systems
732-203-0400
jonr@spartasystems.com

Press Contact
Katy Zack
Articulate Communications Inc.
212.255.0080, ext. 11
kzack@articulatepr.com

SOURCE Sparta Systems, Inc.

Jon Rabinowitz of Sparta Systems, +1-732-203-0400, jonr@spartasystems.com; or
Katy Zack of Articulate Communications Inc., +1-212-255-0080, ext. 11,
kzack@articulatepr.com