TAMPA, Fla., Feb. 21 /PRNewswire/ -- Pilgrim Software, Inc., a world- leading provider of Enterprise Compliance and Quality Management (ECQM) software solutions, today announced that Edwards Lifesciences Corp. , a leader in advanced cardiovascular disease treatments, has selected Pilgrim's fully integrated SmartSolve(R) suite to support its worldwide regulatory compliance and quality management processes.
Edwards will initially implement each SmartSolve module at its corporate location in Irvine, CA, followed by eventual rollout to its 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 efficiently meet FDA regulatory and quality system requirements on a consistent basis.
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 employee training and certification status.
In evaluating automated solution providers last year, Edwards chose Pilgrim Software due to its established history of being an innovative solutions provider within the medical device industry. "Given that we wanted to have an automated CAPA system up and running this spring, we turned to Pilgrim Software," said Vinu Gurukar, senior director of IT, Global Business Effectiveness, Edwards Lifesciences. "We recognized that Pilgrim's applications, with built-in best practices for medical device companies, would enable us to deploy rapidly and meet our target date."
Frost & Sullivan, a global growth consulting firm, recently named Pilgrim Software as the 2007 North American Enterprise Compliance & Quality Management Company of the Year within the Life Science industry, specifically citing Pilgrim's excellence in the Medical Device arena, where it leads all other ECQM providers in enabling its customers to achieve world-class performance.
"Our solutions are built on more than a decade of experience working with medical device and manufacturing companies to address the challenges they typically face in their ongoing effort to remain compliant and to continuously enhance their product and process quality," said Prashanth Rajendran, Pilgrim's Chief Operating Officer. "Each SmartSolve solution will take Edwards' previous key management processes to the next level, ensuring greater process control, accelerated response rates and overall enhanced business performance."
About Edwards Lifesciences Corp.
Edwards Lifesciences, a leader in advanced cardiovascular disease treatments, is the number-one heart valve company in the world and the global leader in acute hemodynamic monitoring. Headquartered in Irvine, Calif., Edwards focuses on specific cardiovascular disease states including heart valve disease, peripheral vascular disease and critical care technologies. The company's global brands, which are sold in approximately 100 countries, include Carpentier-Edwards, Cosgrove-Edwards, FloTrac, Fogarty, LifeStent, PERIMOUNT Magna and Swan-Ganz. Website: http://www.edwards.com.
About Pilgrim Software, Inc.
Pilgrim Software, Inc. is a world-leading provider of Enterprise Compliance and Quality Management solutions for global organizations. Named 2007 North American Enterprise Compliance & Quality Management Company of Year by Frost & Sullivan, Pilgrim helps organizations manage industry and regulatory compliance, reduce manufacturing costs and improve customer satisfaction. For more information, visit Pilgrim Software's website at www.pilgrimsoftware.com.
Contact: Sandy Carson, carsons@pilgrimsoftware.com Pilgrim Software, Inc. Ph: 813.915.1663 Fax: 813.915.1948 www.pilgrimsoftware.com
Pilgrim Software, Inc.CONTACT: Sandy Carson of Pilgrim Software, Inc., +1-813-915-1663, or fax,+1-813-915-1948, or carsons@pilgrimsoftware.com
