CIMdata PLM Industry Summary Online Archive
12 March 2008
Product News
Dassault Systèmes Launches PLM Solutions for Life Sciences Helping Companies Deliver Products to Market Faster by Managing Quality Control and Regulatory Compliance
Dassault Systèmes (DS) at the AdvaMed 2008 Annual Meeting in La Quinta, California, announced the availability of two new solutions developed specifically for the Life Sciences industry. The ENOVIA® Life Sciences Accelerator for Quality Issues™, and the ENOVIA® Life Sciences Accelerator for Change Control™ products, both developed by Integware, Inc., enable customers to lower the total cost of ownership of their IT ecosystem, and help them comply with Quality System Regulation (QSR) and International Organization for Standardization (ISO) regulations in order to bring industry-leading products to market faster and more reliably.
Both Life Science Accelerators are compatible with Dassault Systèmes' 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 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 Systèmes. “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 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 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 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.
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