System Validation Kit reduces FDA validation time.
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Press Release Summary:
System Validation Kit enables medical device companies to incorporate FDA system validation documentation as part of their implementation process. Kit includes all necessary procedures, test scripts, and reports. Portal and component technology provide medical device manufacturers with flexibility needed to support growth as well as to add new capabilities, functions, or technologies.
Original Press Release:
IFS Reduces FDA Validation Time and Costs with New IFS System Validation Kit
CHICAGO, June 2, 2003 - IFS announced its new, cost-saving IFS System Validation Kit today at the Medical Design and Manufacturing East Show, being held June 2-4 in New York. This unique kit lets medical device companies incorporate FDA system validation documentation as part of their implementation process. As a result, the kit significantly reduces the time and costs of the FDA validation process, which typically is treated as an afterthought to the implementation effort.
"More and more medical devices companies are turning to IFS for the kind of fully integrated, single-source solution they need to streamline operations while complying with FDA regulations," said Mike Nordin, IFS North America president. "And now, our new validation kit-which includes all the necessary procedures, test scripts and reports-further reduces their costs and speeds up their time-to-market. Also, our portal and component technology provide medical device manufacturers with the flexibility needed to support rapid growth as well as quickly add new capabilities, functions or technologies in a step-by-step way."
Medical Devices is one of the primary vertical industries IFS serves. IFS Applications(TM) includes standard functionality needed to comply with complex FDA regulations as well as fully integrated device lifecycle management that reduces costs and improves time-to-market, replenishment processing, and cross-operational communications. IFS' medical devices solution offers comprehensive support for mixed-mode manufacturing and supports requirements of 21 CFR, Part 11 (electronic records and electronic signatures), and the Quality System Regulation (21 CRF Part 820), including Device Master Record (DMR) and Device History Record (DHR). Customers include Alden Products, Aircast, MED-TEC, Neuropace, NxStage, Thoratec, Value Plastics, and Neoventa.
About IFS
IFS develops and supplies component-based business applications for medium and large enterprises and organizations. IFS Applications, which is based on web and portal technology, offers 60+ enterprise application components used in manufacturing, supply chain management, customer relationship management, service provision, financials, product development, maintenance and human resource administration. IFS offers customers an easier, more open alternative that can be implemented step by step.
A leading global business applications supplier, IFS has 3,000 employees, with sales in 45 countries, and more than 350,000 users worldwide. The company is listed on the Stockholm Stock Exchange (XSSE: IFS).
More information is available at www.ifsna.com.
IFS Applications is a trademark of IFS Industrial and Financial Systems. All other referenced company or product names are trademarks or registered trademarks of their respective owners.
For additional information, contact:
John Bridges
VP Marketing
IFS North America
Phone: 520 512-2000
Fax: 520 512-2001
john.bridges@ifsna.com
Chris Jensen
President
Jensen Market Relations
Phone: 714 847-7846
Fax: 714 847-4856
chris@jensenmarket.com
