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Pilgrim Software Launches Life Science Industry's First Intelligent Solution for Global Complaint Handling and Adverse Event Reporting



5/10/2013 9:12:03 AM

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Tampa, FL – May 9, 2013 -- Pilgrim Software, Inc., a world-leading provider of Enterprise Quality and Compliance Management software solutions, today announced the most recent release of SmartSolve® Complaint Management, the industry’s first solution with built-in regulatory intelligence to facilitate efficient, accurate and consistent global adverse event reporting and complaint management across the enterprise.

Complaint Management, an integrated component of Pilgrim’s SmartSolve solution suite, makes it easier for pharmaceutical and medical device organizations to expand into new countries by providing them valuable intelligence regarding global complaint management requirements. The solution combines product market approval information with country-specific regulatory reporting requirements to efficiently determine global adverse event reportability. Depending on the country of expansion, Complaint Management leverages pre-built or user-configured decision trees to ensure the right documents are being submitted to the appropriate global regulatory body.

“Complaint handling and regulatory reporting are critical requirements in the Life Sciences industry and any quality management program,” said Thierry Durand, Pilgrim’s Chief Executive Officer. “At Pilgrim, we understand these two processes are frequently intertwined, so our solution, unlike other complaint management solutions, enables users to consistently differentiate critical customer complaints from other issues, and then facilitates accurate global regulatory reporting through its intelligent decision trees.”

Once an adverse event has been identified, Complaint Management’s escalation capabilities help to eliminate bottlenecks and facilitate reporting and resolution of the complaint. The solution drives consistent handling of customer issues and effective, timely resolution to global adverse events through enhanced and configurable workflows, forms and decision trees. These capabilities make it easier for regulatory professionals to design and implement standardized regional processes, leading to reduced regulatory scrutiny and audit time.

“As globalization continues to press outward, Life Sciences companies are looking to improve the efficiency of their operations,” said Atulya Risal, Pilgrim’s Chief Technology Officer. “Likewise, Pilgrim is always looking to boost its customers’ efficiencies by enhancing the functionality of its solution and keeping up with the latest regulatory requirements.

“SmartSolve’s Complaint Management solution includes advancements in its technology and functionality based specifically on recommendations our customers have made. The new features and enhancements allow customers to better address their complaint handling requirements and expedite their business processes while remaining fully compliant with industry regulations on a world-wide scale.”

About Pilgrim Software, Inc.

Pilgrim Software, the world leader of cloud and on-premise enterprise solutions for quality and compliance management, delivers integrated applications for pre- through post-market operations of Life Sciences companies. For more than a decade, Pilgrim's tightly integrated 21 CFR Part 11-compliant system has enabled its clients to proactively manage documents, audits, complaints, nonconformances, corrective/preventive actions, supplier quality, and training, helping ensure product safety and regulatory compliance, reduce manufacturing costs, and improve customer satisfaction. For more information, visit Pilgrim Software’s website at www.pilgrimsoftware.com.



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