Sparta Systems Helps OEMs Prepare for eMDR Mandate

Sparta Systems (Holmdel, NJ), a provider of enterprise quality management software platforms, has outlined tactics that OEMs can use to prepare for the expected FDA mandate requiring companies to file safety reports electronically. The company's five-step approach is meant to help OEMs identify challenges they may encounter and tools they will need when transitioning from paper-based systems to the electronic submission process known as electronic Medical Device Reporting (eMDR)."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," says Mike Jovanis, vice president of product management, Sparta Systems. "The enhanced reporting functionality in our TrackWise software can make this transition as simple and painless as possible."TrackWise is an enterprise process and quality management Web-based software platform that is designed to help companies improve compliance control by consolidating and automating workflow and reporting actions, according to Sparta Systems. The customizable, centralized system enforces process steps to ensure compliance and features personalized, integrated dashboards that provide users with the ability to monitor the status of projects and potential problem areas. Customers can configure the system using point-and-click administrator tools, which eliminates the need for costly code changes and simplifies potential maintenance and upgrade requirements.Since FDA's Center for Devices and Radiological Health (CDRH) implemented voluntary electronic submissions in 2007, it has intended to make electronic reporting mandatory. Proposed budget reductions, administrative savings, and increased management efficiencies at CDRH since then have stemmed from the conversion of its large paper-based systems to electronic systems. These systems include the eMDR program and FDA's Unified Registration and Listing system. The goal of the conversions is to help FDA—which received more than 749,000 reports in 2007 concerning 1368 medical devices—further improve its postmarket signal detection, data analysis, and risk management action, according to a 2009 FDA budget report summary.Sparta has been communicating with FDA as the legislation for the proposed mandate has been refined. The company says its goal in offering its suggestions for how to approach the transition to the eMDR process is to help OEMs reduce associated compliance costs, ensure the safety of medical devices, and foster customer loyalty. Step one of its suggested approach is "thought." Before any eMDR process and software system can be designed, a thorough, candid self-evaluation is required for a company to understand the scope and nature of its business's eMDR needs, says Sparta Systems. Step two is the planning phase. Planning the transition to an electronic submission system will require a company to review and document common and divergent processes because the method and means of receiving, transmitting, and auditing data will be critical, according to Sparta. Step three involves using the information gathered in steps one and two to design a suitable eMDR system. Designing an effective system tailored to the user's needs will result in reduced time and cost spent on testing and implementing the eMDR system, says Sparta. Testing the system is step four. Possible failure scenarios should also be tested to ensure that the appropriate actions take place in the system when the failure is identified, suggests Sparta. The final step is implementation. Careful observation of eMDR users and approvers is important to ensure that they are adhering to correct procedures and that reports are being submitted and filed in a timely manner, Sparta recommends.