CIMdata PLM Industry Summary Online Archive

3 February 2011

Implmentation Investments

Megadyne Medical Products Selects Pilgrim Software as its Quality and Compliance Solution Provider

Pilgrim Software, Inc. announced that Megadyne Medical Products, Inc., a Utah-based manufacturer of electrosurgical products, will implement Pilgrim’s integrated suite of automated products beginning with its Document Management solution.

Pilgrim’s Document Management solution will replace a paper-based system to better manage Megadyne’s increasing volume of documentation and related change controls by enabling the company to effectively create, manage and share critical documents and best practices across its entire enterprise. By connecting people, processes and documents, Pilgrim’s solution improves organizational effectiveness, agility, and competitiveness, and enables the company to fully integrate the Quality Management System.

Additionally, Megadyne will implement Pilgrim’s solutions to enhance its complaints management and Corrective and Preventive Action (CAPA) process, as well as internal and external audit procedures, and internal training services. Each of these solutions will support Megadyne’s certified Quality System that conforms with global industry requirements including 21 CFR Part 820, ISO 13485:2003, Canada Medical Device Requirements, European Medical Device Directive 93/42/EEC, and Japanese MHLW Ordinance No. 169.

“We selected Pilgrim’s solutions because it has a proven track record of supporting Medical Device manufacturers with its integrated best practices,” said Ronda Magneson, Regulatory Affairs Director for Megadyne. “Now, by automating our documentation process, Megadyne will streamline and enforce procedures as well as reduce the non-value added time required to create, manage and find the relevant documents quickly and efficiently.”

“With the adoption of our solution, Megadyne is gaining enhanced visibility and collaboration across the enterprise to allow rapid identification and resolution of discrepancies so as to continuously ensure the quality of its records, and further, the integrity of its products,” said Prashanth Rajendran, Pilgrim’s Chief Operating Officer. “We are very pleased that Megadyne is joining a growing number of Life Sciences companies that continue to rely on Pilgrim’s ERCQM platform for their quality and compliance requirements.”

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