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PLM Products Address Life Sciences Quality

With product quality and regulatory issues among the top reasons that life sciences product launches fail, Dassault Systèmes is taking aim at the problem.

Dassault Systèmes, a Paris-based supplier of 3D and Product Lifecycle Management (PLM) solutions, has 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 were both developed by PLM consultant Integware Inc., Fort Collins, Colo. Both products enable customers to lower the total cost of ownership of their information technology (IT) ecosystems, Dassault said, while helping 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.

Quality failures

When companies were questioned as part of a recent study by AMR Research Inc., Boston, 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.

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 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 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."

Lower regulatory risk

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, Dassault said. 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.

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, Dassault said. 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.

Dassault Systèmes

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