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Supply chain planning and execution software
News Release from: MatrixOne | Subject: MatrixOne Accelerator for FDA Compliance
Edited by the Manufacturingtalk Editorial
Team on 28 November 2003
PLM solution designed for medical device
makers
PLM solution designed specifically for the medical device market enables manufacturers to ensure regulatory compliance while accelerating new product introductions.
MatrixOne, a leading provider of collaborative product lifecycle management (PLM) solutions for the value chain, has announced the availability of the MatrixOne Accelerator for FDA Compliance, a single, PLM solution designed specifically for medical device manufacturers which helps them to achieve FDA compliance throughout their product lifecycle processes, while drastically reducing product development costs and accelerating new products to market The MatrixOne Accelerator for FDA Compliance has been developed based on MatrixOne's rich domain expertise working with some of the world's most innovative companies in the medical device industry* enabling companies of all sizes to rapidly implement a state-of-the-art PLM environment that closely meets the needs of their business
This article was originally published on Manufacturingtalk on 13 Apr 2001 at 8.00am (UK)
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MatrixOne's Accelerator for FDA Compliance provides medical device manufacturers with a solution to facilitate and automate business processes and is designed to assist with regulatory compliance on a global basis.
Companies in the medical device industry must ensure FDA compliance throughout the entire design and manufacturing process.
Specifically, as regulated companies, medical device manufacturers must ensure compliance with evolving FDA Regulations such as those outlined in Title 21 of the Code of Federal Regulations (CFR), especially 21 CFR Part 11 and 21 CFR Part 820.
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Pete Schaubach, chief information officer for ev3, said, "The Accelerator for FDA Compliance is a very attractive offering as it has been designed specifically to solve the problems we are facing as a medical device manufacturer.
It includes the specific applications, nomenclature and business processes that we need to enable us to quickly deliver products to market that are compliant with Federal regulations.
This is important for us as a company because it ensures that the innovation we are creating can be brought to market and utilised as quickly as possible." The MatrixOne Accelerator for FDA Compliance is an offering which allows medical device manufacturers to easily and effectively create secure, collaborative project spaces for virtual teams, including global development teams and outsourced partners.
It allows them to electronically manage all product information, including the Design History File (DHF), the Device Master Record (DMR), and the Device History Record (DHR) as well as all non-product related documents such as global product documentation, procedures, trademarks, contracts and patents throughout the product lifecycle - while maintaining full audit trails.
By having a single view of the product lifecycle process, medical device manufacturers will be able to keep their engineering, manufacturing, quality and materials departments synchronised on new or changing product information, resulting in improved consistency, quality and volume, and faster compliance and submissions with the FDA requirements.
The MatrixOne Accelerator for FDA Compliance allows medical device manufacturers to rapidly and efficiently deliver compliant products to market by: * Easily and effectively creating secure collaborative "Project Spaces" for virtual teams.
* Driving compliance with FDA 21 CFR Part 11; electronic records and signatures and with FDA 21 CFR Part 820; quality system regulations.
* Electronically managing all product information throughout the product lifecycle, including the Design History File, the Device Master Record, and the Device History Record.
* Easily managing the Phase/Gate design control processes through configurable, new product introduction process templates.
* Effectively managing all product and non-product related documents such as internal procedures and specifications.
* Dynamically linking Corrective Action/Preventive Action processes directly to affected product and/or non-product information.
Availability - the MatrixOne Accelerator for FDA Compliance is currently available through MatrixOne or one of its authorised resellers or distributors.
About MatrixOne - MatrixOne, (NASDAQ: MONE) is a recognised leader in delivering collaborative Product Lifecycle Management (PLM) solutions.
We provide flexible solutions that unleash the creative power of global value chains to inspire innovations and speed them to market.
MatrixOne's customers include global leaders in the aerospace and defence, automotive, consumer products, high technology, life sciences, machinery, and the process industries, including Agilent Technologies, General Electric, Honda, Johnson Controls, Philips, Procter and Gamble, Siemens, and Toshiba.
MatrixOne is headquartered in Westford, Massachusetts with locations throughout North America, Europe, and Asia/Pacific.
MatrixOne and the MatrixOne logo are registered trademarks and Collaborative Product Lifecycle Management Solutions for the Value Chain and MatrixOne Engineering Central are trademarks of MatrixOne, All other trademarks and service marks are the property of their respective owners.
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