When companies were questioned as part of a recent AMR Research study, 31 percent of U.S. respondents identified product quality as one of the top reasons why product launches fail, while 20 perfect also highlighted regulatory issues as being a key factor(1).
Both Life Science Accelerators are compatible with Dassault Systemes' recently announced V6 PLM platform to offer customers a single, flexible solution with integrated business processes to better manage core intellectual property. Based on a service oriented architecture (SOA), the Life Science Accelerators facilitate seamless interaction between all ENOVIA PLM business processes including Corrective and Preventive Actions (CAPA), Product Complaints, Change Control, Product Development and Supplier Control.
"After years of working with some of the world's leading life sciences companies, we are developing a series of products that leverage best practices to better serve specific industry needs," said Mickey Garcia, director of Life Sciences Industry Strategy, ENOVIA, Dassault Systemes. "Our customers - both pharmaceutical and medical device manufacturers - rely on ENOVIA solutions as central tools for managing product quality, promoting greater supply chain collaboration, and ensuring regulatory compliance."
ENOVIA Life Sciences Accelerator for Quality Issues
The ENOVIA Life Sciences Accelerator for Quality Issues provides a flexible, ready-to-use business process for the management of Quality Issues such as CAPAs and Product Complaints. The Accelerator enables customers to automate many of the routine aspects of quality investigations, reducing waste and focusing attention on the truly critical issues of risk, root cause and remediation. This product also helps customers to verify that the quality investigation is executed properly and that all required deliverables are completed resulting in lower regulatory risk.
ENOVIA Life Sciences Accelerator for Change Control
The ENOVIA Life Sciences Accelerator for Change Control also provides a ready-to-use business process for the management of changes to regulated documents, procedures and specifications throughout an organization. Delivering a single, robust Change Control process, it improves the speed of changes and reduces errors introduced by manual handoffs. This approach is designed to help customers reduce regulatory risk by automatically enforcing critical process steps, guiding regulatory, safety and financial impact assessments and capturing Part 11-compliant signatures based on a company-defined approval matrix.
About Dassault Systemes:
As a world leader in 3D and Product Lifecycle Management (PLM) solutions, Dassault Systemes (Nasdaq: DASTY; Euronext Paris: #13065, DSY.PA) brings value to more than 100,000 customers in 80 countries. A pioneer in the 3D software market since 1981, Dassault Systemes develops and markets PLM application software and services that support industrial processes and provide a 3D vision of the entire lifecycle of products from conception to maintenance to recycling. The Dassault Systemes portfolio consists of CATIA for designing the virtual product - SolidWorks for 3D mechanical design - DELMIA for virtual production - SIMULIA for virtual testing - ENOVIA for global collaborative lifecycle management, and 3DVIA for online 3D lifelike experiences. Dassault Systemes is listed on the Nasdaq (DASTY) and Euronext Paris (#13065, DSY.PA) stock exchanges. For more information, visit www.3ds.com
(1) AMR Research, "The Product Lifecycle Management Spending Report," February 25, 2008.
CATIA, DELMIA, ENOVIA, SIMULIA, SolidWorks and 3D VIA are registered trademarks of Dassault Systemes or its subsidiaries in the US and/or other countries.
Dassault SystÃ¨mes Press Contacts:
David Coates (ENOVIA), +1 (978)Â 442 2708
Derek Lane (DS Americas), +1 (818) 673-2243
Mikiko Igarashi (DS AP), +81-3-5442-4138
Arnaud Malherbe (DS EMEA), +33 (0)1 55 49 87 73