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Pilgrim Quality Solutions

FDA Compliance

Product News: Pilgrim Software Launches Platform for Regulatory Reporting

New solution eases adverse-event reporting to global regulatory bodies

Published: Monday, July 12, 2010 - 10:05

(Pilgrim Software: Tampa, FL) -- Pilgrim Software Inc., a provider of enterprise risk, compliance, and quality management (ECQM) software solutions, has announced the global availability of its expanded Regulatory Reporting platform. Rounding out the platform, the new MedDRA adapter integrates with Pilgrim’s Complaints Management solution to ease adverse-event reporting to global regulatory bodies.

The new software allows companies to capture their products’ inquiries, complaints, and adverse events within a single environment. This makes it easy to analyze, trend, and report on safety data anywhere throughout the product life cycle. The MedDRA adapter supports the reporting process by allowing Complaints Management users to easily access the MedDRA Dictionary of terms (i.e., codes) to quickly update required MedWatch Adverse Event Reports.

“As globalization continues to press outward, many regulatory agencies are looking to improve the efficiency of their operations,” says Atulya Risal, Pilgrim Software’s chief technology officer. “As a result, regulations are changing, electronic submissions are increasing, and the codes and the structure of how data are used will continue to expand.

“By ensuring that manufacturers are using the latest accepted terminology and helping to provide clear, concise, complete, and accurate data in their reports, the MedDRA capability supports ongoing compliance with reporting needs now and as the regulations continue to evolve,” Risal adds.

The MedDRA Dictionary integration capability enables users to capture any of more than 70,000 MedDRA terms, from any version and using any language, to support the reporting of adverse events throughout a clinical trial to post-market product life cycle. The software automatically captures all the MedDRA terms for the patient symptom into a record to support the periodic safety analysis, and the advanced search feature allows for quick analysis of records containing MedDRA terms.

“Pilgrim’s Regulatory Reporting solution allows drug and combination-product manufacturers to readily identify adverse events before they become critical issues, facilitating proactive risk avoidance and product regulatory and safety adherence,” says Prashanth Rajendran, Pilgrim’s chief operating officer. “Companies that adopt Pilgrim’s Regulatory Reporting platform will benefit from a resulting increase in the accuracy and productivity of their “pharmacovigilance” by reducing time spent addressing errors and the man-hours to pull together the data and analysis necessary for periodic safety reports.”

In developing its current adverse-event “Regulatory Term” management solution, Pilgrim Software is sharing its design of the hierarchical capabilities for the new event codes from the Food and Drug Administration’s Center for Devices and Radiological Health (CDRH). Pilgrim will also be involved when the MedDRA team brings the new CDRH codes into the MedDRA Dictionary.

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Pilgrim Quality Solutions

Pilgrim Software Inc. is a developer and provider of enterprise risk, compliance, and quality management software (ERCQM) 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 pioneered effective, integrated software solutions for the life science industries, as well as manufacturers in the automotive, aerospace and defense, and other nonFDA-regulated industries.