Sparta Systems(TM) Outlines Tips And Tactics To Prepare For EMDR Mandate

Main Category: IT / Internet / E-mail
Also Included In: Medical Devices / Diagnostics
Article Date: 17 Jun 2009 - 4:00 PDT

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Sparta Systems, Inc., the maker of TrackWise(R) software and the market leader in enterprise quality and compliance management solutions, 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."

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

Source: Sparta Systems, Inc