CIMdata PLM Industry Summary Online Archive

9 October 2008

Product News

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

Dassault Systèmes (DS) 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.

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 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.

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