Product category:
PLM and collaboration software
News Release from: Dassault Systemes | Subject: FDA Compliance solution
Edited by the Engineeringtalk Editorial
Team on 09 July 2002
Software manages data for FDA compliance
The SmarTeam FDA Compliance solution aims to streamline product development lifecycles for customers in the life science industry.
The SmarTeam FDA Compliance solution aims to streamline product development lifecycles for customers in the life science industry As part of a suite of industry specific solutions, SmarTeam FDA Compliance solution provides collaborative product development solutions to speed products to market while fostering compliance with FDA 21 CFR Part 11 regulations
This article was originally published on Engineeringtalk on 29 Jan 2004 at 8.00am (UK)
Related stories
Software speeds F1 aerodynamics design
Toyota Motorsport has used the Dassault Systemes Generative Car Design industry solution to develop F1 car designs for the 2004 season.
Upgrade takes product lifecycle management further
Dassault Systemes and IBM are releasing Version 5 Release 13 (V5R13) of their product lifecycle management (PLM) portfolio, comprising Catia, Enovia and Smarteam.
Delivering products to market on time and on budget is particularly challenging in the pharmaceutical and medical device industries due to rigorous enforcement of FDA 21 CFR Part 11 regulations.
The regulations govern the use of electronic identification and signatures, and data surrounding the manufacture of medical products for the US public health system.
The regulations have reduced the clearance rate for new products.
Further reading
Redesigned line doubles Indian car production
Engineering consultant Aepro has used Delmia products to help achieve the goal of doubling the production of Tata Motors' Indica.
Simulation spotlights process inefficiencies
ArvinMeritor has selected Delmia Quest and Delmia Process Engineer (DPE) to evaluate its current assembly processes.
SmarTeam FDA Compliance solution provides an affordable and rapidly implemented solution that manages and controls product data with respect to the federal requirements, empowering life science companies to reduce costs, improve productivity and cut time to market.
"A major challenge facing medical device manufacturers (MDM) and pharmaceutical companies today is how to minimise the delay to market caused by the regulatory environment", says Yuval Gaoni of EGO Engineering and Operations.
"By automating our client's processes and data management with SmarTeam, they have been able to advance rapidly, avoiding delays in product launches and costly rework.
Missing or inaccurate information in the development cycle can delay government approval or worse, result in warning letters that can stop production for extended periods of time".
"The challenges faced by the life science industry in bringing products to market are unique, with often complex products and intense competition, within a highly regulated environment", says Avichay Nissenbaum, executive vice president product marketing at SmarTeam.
"Leveraging the power of SmarTeam together with the FDA Compliance solution provides our customers in the medical device and pharmaceutical industries the key to alleviating strategic business and product development issues being faced today".
SmarTeam's industry-leading product lifecycle collaboration system facilitates innovation and collaboration between product engineers, and across the extended enterprise.
Tightly integrated into existing CAD and enterprise systems, SmarTeam FDA Compliance solution fulfils the demands of life science manufacturers, managing all product information in the SmarTeam database in a format that is easily accessible and instantly presentable to the certifying agency.
• Dassault Systemes: contact details and other news
• Email this article to a colleague
• Register for the free Engineeringtalk email newsletter
• Engineeringtalk Home Page
Search the Pro-Talk network of sites
