Tampa, FL – June 21, 2010 -- Pilgrim Software, Inc. , a world-leading provider of Enterprise Risk, Compliance and Quality Management (ERCQM) software solutions, today announced that Deborah Kacera, Industry Solutions Director for Pilgrim, will lead an inclusive conference workshop — Prepare and Implement eMDR — at the Center for Business Intelligence’s 8th Annual Conference on Product Complaints for Bio/Pharmaceuticals and Medical Devices, on June 25, 2010.  Kacera’s workshop will present best practices case studies and real-world examples of implementing an electronic medical device adverse event reporting (eMDR) program.

Per FDA guidelines, the Pharmaceutical and Medical Device industries are required to document, analyze and record every complaint that is received in any arena and by any employee in the organization.  The FDA will soon require all manufacturers to submit information regarding these adverse events, electronically, through their eMDR initiative. The extended comment period ended on November 16, indicating that a final version should be released in 2010.

“The FDA is focusing on electronic flow of information as evident by the changeover this past weekend of the CDRH servers to the new data center to support the FDA's Information Technology for the 21st Century (ICT21) program,” Kacera said.  “The FDA is ramping up to receive information electronically from industry and from consumers.  eMDR will be made mandatory…..it is just a matter of ‘when.’”

The interactive workshop Kacera will lead will provide attendees with a detailed look at a successful recent eMDR implementation to better prepare them for their own transition.  Attendees will examine the current status of eMDR, learn how to implement a successful eMDR program, and take away insights from people who have worked through the implementation and go-live phases.

The 2010 CBI conference, “Benchmark Policies and Procedures to Ensure Regulatory Compliance for Effective Processing, Trending and Analysis of Complaints,” provides QA/ QC professionals the chance to convene and discuss best practices for handling product complaints. The conference is being held June 23 - 25, 2010 in Alexandria, VA.

About Pilgrim Software, Inc.   
Pilgrim Software, Inc. is a world-leading provider of Enterprise Risk, Compliance and Quality Management solutions for global organizations. Named North American Enterprise Compliance & Quality Management Company of the Year – Best Practices by Frost & Sullivan, Pilgrim helps organizations manage industry and regulatory compliance, reduce manufacturing costs and improve customer satisfaction. For more information, visit Pilgrim Software’s website at http://www.pilgrimsoftware.com/.