PLM Software is suited for medical device industry.
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Press Release Summary:
AgileMD product lifecycle management (PLM) solution addresses problems that occur throughout entire product lifecycle and manages medical device product record from research and development to product phase-out. It ensures regulatory compliance by satisfying FDA requirements for closed-loop, Corrective Action/Preventative Action management and FDA Title 21 CFR Part 11 for electronic records and signatures. Also included: best practices templates and Validation Protocol Paks.
Original Press Release:
Agile Launches AgileMD-Product Lifecycle Management for the Medical Device Industry
AgileMD enables organizations to bring quality products to market quickly, profitably and in compliance
SAN JOSE, Calif.-July 14, 2003--Agile Software Corporation (NASDAQ: AGIL), today announced the launch of AgileMD, a product lifecycle management (PLM) solution designed specifically for the medical device industry. AgileMD helps medical device companies increase revenue by accelerating time to market, increase profits by reducing operating and direct material costs, and ensure regulatory compliance.
"There is no doubt that Agile's industry-specific PLM solution, AgileMD, will considerably strengthen Agile's support of the dynamic medical device and instrumentation market," said Gisela Wilson, director of product life-cycle management solutions, IDC. "This market depends on its ability to rapidly innovate its product offerings, and at the same time, support rigorous FDA requirements for electronic documentation. IDC believes that AgileMD can help medical device and instrumentation manufacturers develop and maintain competitive product portfolios."
Leading companies in the medical device industry are currently using Agile to achieve key PLM business objectives including:
o Increased revenue by improving cycle time up to 60%.
o Increased profits from operating cost reductions of 25% and direct materials cost reductions of 5%.
o Satisfying FDA requirements for closed-loop, Corrective Action/Preventative Action (CAPA) management.
o Compliance with FDA Title 21 CFR Part 11, which prescribes the accepted use of electronic records and signatures.
"Lengthy product introduction time, document control process issues and regulatory compliance have always been challenges in the medical device industry," said Dave Rudzinsky, CIO of Hologic. "Agile has created a complete solution that can really help manage a product from conception through the end of life."
"The global market for medical devices is rapidly growing. Time to market problems, cost of documentation, compliance, and outsourcing complexities are all critical business issues," said Jay Fulcher, president and COO, Agile. "More medical device manufacturers have chosen Agile over any other pure play PLM provider because of Agile's comprehensive solution for building competitive advantage while ensuring regulatory compliance."
AgileMD is:
o Agile's complete PLM solution for managing the medical device product record from research and development, clinical trials, regulatory approval, new product introduction, market acceptance, to product phase-out.
o Medical device best practices templates that deliver fast time to value.
o Validation Protocol Paks that reduce the time and cost to validate an instance of AgileMD.
o MEDSIG, Agile's Medical Industry Special Interest Group, that brings together professionals and thought leaders from across the industry to drive future AgileMD development.
o Agile's Quality Assurance Program that provides our customers with the confidence that their solutions exceed the industry standards for quality and compliance.
o Agile's Guaranteed Business Results Program that ensures customer expectations, milestones, and measurable results are achieved.
o AgileMD's partner ecosystem, which brings together best of breed partners-including Deloitte Consulting, Adobe, Peoplesoft, and J.D. Edwards-to deliver complementary solutions, solid integrations, consulting and validation services.
"AgileMD is the first comprehensive PLM solution for the medical device industry that addresses problems that occur throughout the entire product lifecycle instead of at a single point," said Chris Park, Partner in the Life Sciences practice of Deloitte Consulting. "We are pleased to partner with a leader in the industry and work together to provide medical device best practices, help companies streamline their processes and manage their products more efficiently."
About Agile Software Corporation
Agile Software Corporation (Nasdaq: AGIL) helps companies drive profits, accelerate innovation, collaborate with partners, and leverage intellectual property throughout the product lifecycle. With a broad suite of enterprise class PLM solutions, time-to-value focused implementations, and a unique Guaranteed Business Results program, Agile helps companies get the most from their products. Ballard Power Systems, Boeing, Dell Computer, Flextronics International, GE Medical, Hitachi, Metaldyne, Microsoft, and QUALCOMM are among the 850+ customers in the high tech, life sciences, automotive, aerospace and defense, consumer products, and industrial products industries that have realized high impact results through their use of Agile solutions. For more information, call 408-975-3900 or visit Agile at www.agile.com < agile.com> .
