A Medical Device Daily

Pilgrim Software (Tampa, Florida), a provider of enterprise compliance and quality management (ECQM) software, reported that Edwards Lifesciences (Irvine, California), a developer of cardiovascular technologies and systems, has selected Pilgrim's SmartSolve suite to support its regulatory compliance and quality management processes.

Edwards will initially implement each SmartSolve module at its corporate offices, followed by rollout to multiple global sites.

Pilgrim is working with Edwards to implement SmartCAPA first. The automated CAPA solution, and other SmartSolve solutions including SmartComplaints, SmartAudit, SmartDoc, and SmartTrain, will replace Edwards' existing manual systems to enable the company to meet FDA regulatory and quality system requirements.

Edwards recently reported receiving a warning letter from the FDA concerning quality systems, quality systems training, documentation and complaint handling at its Irvine facility.

Each Pilgrim solution supports specific quality and compliance needs within Edwards' global operations. SmartCAPA enables Edwards to better manage its CAPA containment and investigations, and identify root causes of nonconformances and deviations, thereby expediting resolutions. SmartComplaints will enhance the company's electronic workflow and escalation capabilities to quickly close out customer complaints. SmartAudit will improve the audit process by producing accurate audit records more rapidly. SmartDoc will allow Edwards to better manage its library of SOPs, and other critical documents through more rapid and accurate traceability. SmartTrain will assist Edwards in automating its training management system and enable the company to have global visibility of emsployee training and certification status, according to Pilgrim.

Edwards focuses on specific cardiovascular disease states including heart valve disease, peripheral vascular disease and critical care technologies.