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Dassault Systèmes Unveils Stage Gate Solution to Enhance New Product Introduction in Life Sciences Arena


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Built on V6 Platform, Latest ENOVIA Life Sciences Accelerator Helps Customers Manage Complex Global Business and Regulatory Environment to Speed Product Development and Reduce Waste

Lowell, MA – Dassault Systèmes (DS) (Nasdaq: DASTY; Euronext Paris: #13065, DSY.PA), a world leader in 3D and Product Lifecycle Management (PLM) solutions, today announced the availability of a new PLM solution developed specifically for the life sciences industry. The fourth in a series of new Life Sciences Accelerators introduced in the last six months, the ENOVIA Life Sciences Accelerator™ for Stage Gate was developed in partnership with Integware Inc., a key Dassault Systèmes partner and a recognized leader in helping life sciences companies automate compliance, accelerate innovation, reduce product development costs and drive strategic business development.

The stage gate process establishes a structure for the introduction of new products, from concept to launch, by ensuring that cross-functional teams complete a clearly defined series of steps in each stage prior to moving to the next stage of product development. Designed to address the complexity of collaboratively managing the product introduction process across multiple regions, functions and cultures, the Life Sciences Accelerator for Stage Gate offers an out of the box solution to ensure the completion of design control deliverables and allows for automatic tracking of the resulting Design History File (DHF). Project managers can also maximize management visibility and control with advanced visual project tracking reports. This approach allows customers to improve consistency and reduce waste while ultimately speeding time to market.

Dassault Systèmes offers the Life Sciences Accelerator for Stage Gate as part of the V6 PLM platform which is designed to spur global, collaborative innovation by providing key stakeholders with access to information throughout the product lifecycle from product development to manufacturing to end-of-life. The V6 approach enables customers to better manage core intellectual property by means of a single, flexible solution with ready-to-use, out-of-the-box PLM business processes. Based on a service-oriented architecture (SOA), the Life Sciences Accelerators reinforce Dassault Systèmes commitment to offering industry-specific solutions which apply to specific life sciences business processes including Corrective and Preventive Actions (CAPA), Product Complaints, Change Control, Product Development and Supplier Control.

“Life sciences companies need processes and technologies that stitch together the ‘fuzzy front end‘ of new product discovery with product and process development, tech transfer, commercialization, and life cycle management,” stated Wayne McDonnell, research director, Life Sciences, AMR Research in a recent AMR Research report entitled The Growing Need for PLM in Life Sciences. “From an internal perspective, PLM provides capabilities for managing the spectrum of activities required to bring an entire portfolio of programs and products to market…At the program or product team level, PLM strategies help streamline collaboration and PLM systems provide a platform for product, document, and change management.”

The ENOVIA Life Sciences Accelerator for Stage Gate enables companies to:

° Improve time-to-market and adhere to regulatory compliance while maximizing efficiency and reducing collaboration costs
° Manage new product development projects, activities, and deliverables
° Embed compliant best practices and Critical-to-Quality (CTQ) drivers into standard, repeatable project templates
° Provide a highly visual view of the deliverables and stages using functional swim lane views to ensure on-time completion of all design control activities
° Provide easy, real-time visibility into all the critical projects within the organization

“This product is the latest in a series of life sciences accelerators that meet specific needs within the new product introduction process,” said Ray Wodar, director of Consumer & Life Science Solutions, ENOVIA, Dassault Systèmes. “Designed to address the need to decrease costs associated with product development while dramatically improving quality, reliability, and timeliness of product introductions, the ENOVIA Life Sciences Accelerator for Stage Gate enables companies to take advantage of new market opportunities as they arise.”

The Life Sciences Accelerator for Stage Gate dramatically reduces regulatory risk and ensures consistency of design control deliverables in accordance with U.S. Federal Drug Administration (FDA) regulations. Organizations can satisfy Quality Systems Regulation (QSR)/ISO regulatory requirements while achieving Six Sigma objectives through enhanced process control, metrics, and real time reporting.

About Dassault Systèmes
As a world leader in 3D and Product Lifecycle Management (PLM) solutions, Dassault Systèmes brings value to more than 100,000 customers in 80 countries. A pioneer in the 3D software market since 1981, Dassault Systèmes 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. The Dassault Systèmes 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 Systèmes is listed on the Nasdaq (DASTY) and Euronext Paris (#13065, DSY.PA) stock exchanges. For more information, visit http://www.3ds.com

CATIA, DELMIA, ENOVIA, SIMULIA, SolidWorks and 3D VIA are registered trademarks of Dassault Systèmes or its subsidiaries in the US and/or other countries.



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