Product lifecycle management solution to manage risks, expenses of compliance; accelerate time to market
Menlo Park, CA — August 25, 2004 — Arena Solutions Inc., a provider of on-demand product lifecycle management (PLM), today announced that it is offering a solution for medical device companies seeking to manage the risks and expense associated with Food and Drug Administration (FDA) compliance while also cutting the cost and time it takes to bring new products to market.
Arena said its PLM solution has already been adopted by a number of medical device companies, including Align Technology, Zassi Medical Evolutions, NuVasive, Neurologica and NeoGuide Systems.
According to Arena, the solution is designed to support industry requirements for the rapid development and introduction of new products while simultaneously complying with FDA requirements, such as Title 21 CFR Part 11, which define the accepted use of electronic records and signatures. Arena's solution package includes implementation guidelines with best practices, validation planning guidelines, validation protocols and professional services.
"Using Arena's Validation Kit saved us thousands of dollars and at least a month of work," commented David Sapuppo, vice president of manufacturing and quality assurance representative for Zassi Medical Evolutions. "We were able to map our quality operating procedures and user requirements to Arena's validation protocol templates and run the entire validation in less than a week."
Sapuppo added that in order to remain competitive and profitable as a virtual manufacturer, his company needed to minimize overhead while maintaining document controls without sacrificing compliance to any regulatory requirements. "Arena PLM is an externally hosted server solution that really works far better than our older internal server-based application."
Arena said its PLM solution manages the medical device product record throughout research and development, clinical trials, regulatory approval, and market entry, through end of life. Michael Topolovac, CEO of Arena Solutions, said, "Arena PLM allows our medical device customers to put more of their research and development budgets into actual product innovation by reducing their cost of compliance with rigorous and obligatory FDA regulations."