Pilgrim Software, Inc., a world-leading provider of Enterprise Compliance and Quality Management (ECQM) software solutions, today announced the availability of its eMDR Electronic Submission of Post-Market Medical Device Reports to the Food and Drug Administration (FDA).
The eMDR Electronic Submission capability is part of Pilgrim’s SmartComplaints solution that aids medical device manufacturers with the recording, processing, investigation and resolution of a complaint or Adverse Event, including the submission of regulatory reports to the FDA (approved by Center of Radiological Health CDRH since May 2005), EMEA, Canada, Japan and Australia. Pilgrim’s new eMDR Electronic Submission capability will expedite adverse event reports to the FDA through their FDA Gateway using XML technology and complying to HL7 standards.
Pilgrim has partnered with the FDA since the inception of its pilot program to modernize the data entry process for electronic reporting of adverse events. Pilgrim has been providing key insights into improving the robustness of the FDA’s eMDR technology through feedback sessions and rigorous testing to accommodate all adverse events scenarios its customers’ experience ranging from simple, to complex, to longer-term implantable medical devices scenarios. While working with more than half of Pilgrim’s medical device beta customers to address all best practices and error-proofing for data entry for electronic reporting, Pilgrim’s SmartComplaints eMDR will be able to help medical device organizations with automatic easy reporting of low-volume submissions through FDA’s WebTrader and through B2B for high volume submissions.
“With functionality built into SmartComplaints for direct electronic reporting to the FDA, customers will reduce overall reporting errors and timing to better support the industry’s and FDA’s commitment to product safety and vigilance and cost reduction,” said Nikki Willett, Vice President of Marketing and Regulatory Products. “Through Pilgrim’s dedication in working with the FDA and the advancements in our own and FDA’s technology, medical device companies will be able to rapidly get their eMDRs transferred and approved, ultimately improving the well being of our medical community and patients worldwide.”
About Pilgrim Software, Inc.
Pilgrim Software, Inc. is a world-leading provider of Enterprise Compliance and Quality Management solutions for global organizations. Named 2007 North American Enterprise Compliance & Quality Management Company of the Year 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 www.pilgrimsoftware.com.