LOWELL, Mass., Mar. 12, 2008-
Dassault Systèmes (DS) (Nasdaq: DASTY; Euronext Paris: #13065, DSY.PA),
a world leader in 3D and Product Lifecycle Management (PLM) solutions,
today 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.
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 factor1.
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.”
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. |
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