Directories

Physio-Control To Implement Pilgrim Software For Global Regulatory & Quality Management

2012-03-07

TAMPA, Fla. ---- Pilgrim Software, Inc., a world-leading provider of Enterprise Risk, Compliance and Quality Management (ERCQM) software solutions, today announced a strategic partnership with Physio-Control, Inc., the global leader in professional emergency response products and services, whereby Physio-Control will implement Pilgrim’s integrated, closed-loop platform for document management, training, audit and risk management, as well as associated applications for regulatory and internal reporting and analytics.

Physio-Control recently began operating independently following years as a wholly-owned subsidiary of Medtronic. Now, as it focuses on expansion of its quality and compliance systems to accommodate the global enterprise, Physio-Control is investing in next generation compliance management systems to replace previously disparate systems that combined manual and electronic forms and spreadsheets for documenting, tracking and reporting on quality and compliance-related processes. The fully-closed loop, integrated system from Pilgrim will support Physio-Control’s continued global initiative to manage overall compliance, monitor quality, mitigate potential risk, increase productivity, reduce costs and drive continuous improvement.

“With the implementation of Pilgrim’s automated and integrated risk, quality and compliance management software systems, we now have a platform for realizing our automation vision in these critical areas,” said Jim Dabbs, Vice President of Quality Assurance for Physio-Control. “Physio-Control is now positioned to maximize operational efficiencies while we continue to strive to set the bar for regulatory compliance, which will ensure a higher level of customer satisfaction and further solidify our well-known reputation as a leader in the medical device industry.”

“Pilgrim’s solution provides this pioneering medical device company with industry best practice workflows that create an extremely efficient model for meeting both compliance requirements and operational excellence initiatives,” said Thierry Durand, Pilgrim’s Chief Executive Officer.

Physio-Control had already begun using Pilgrim’s solution for electronic submissions of Post-Market Medical Device Reports (eMDR) to the Food and Drug Administration (FDA) and CAPA workflow. The eMDR capability supports the recording, processing, investigation and resolution of a complaint or Adverse Event, including the submission of regulatory reports to the FDA, EMEA, Canada, Japan and Australia.

All of Pilgrim’s integrated solutions are being hosted by Pilgrim’s SAS 70-certified on-demand platform. Engaging Pilgrim’s solutions via the On-Demand platform provides Physio-Control with a distinct competitive advantage. Compared to traditional software implementation and maintenance models, Pilgrim On-Demand involves a lower total cost of ownership, reduced overhead, a high degree of scalability, increased accessibility, improved collaborative productivity, easier implementation, and improved security with optimal performance.

About Physio‐Control, Inc.

Physio‐Control, Inc. is headquartered in Redmond, Washington. The company operates in over 100 countries and is the world’s leading provider of professional emergency medical response solutions. The company’s professional products include LIFEPAK® monitor/defibrillators, the LUCAS®2 chest compression system, and the LIFENET® System cloud-based data management tools. Physio-Control also provides a line of automated external defibrillators (AEDs) for emergency use by bystanders in workplace environments, airports, schools and communities.

About Pilgrim Software, Inc.

Pilgrim Software, Inc. is a world-leading provider of Enterprise Risk, Compliance and Quality Management solutions for global organizations. Through its integrated platform, Pilgrim helps organizations manage industry and regulatory compliance, address potential risks, reduce manufacturing costs and improve customer satisfaction. Pilgrim has been named North American Enterprise Compliance & Quality Management Company of the Year – Best Practices by Frost & Sullivan, and winner of its North American Best-In-Class Customer Value Enhancement Award in the Enterprise Risk, Compliance and Quality Management Market for the Life Sciences Industry.

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