Pilgrim Software Launches Integrated Platform for Regulatory Reporting

Pilgrim Software Inc., a provider of enterprise risk, compliance and quality management (ECQM) software, has announced the global availability of its expanded Regulatory Reporting platform. In addition, the company has introduced the MedDRA adapter, which integrates with its Complaints Management product to simplify adverse event reporting to global regulatory bodies. The integrated platform allows companies to capture product inquiries, complaints and adverse events within a single environment that allows for the ability to analyse, trend and report on safety data anywhere throughout the product lifecycle. The MedDRA adapter supports the reporting process by allowing users of the company’s Complaints Management to access the MedDRA Dictionary of codes to update required MedWatch Adverse Event Reports.

“As globalisation 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 is 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.”

Tags: MedDRA, Pilgrim Software, regulatory reporting