REVISED: Genzyme Boosts Quality Using Dyadem Quality Lifecycle Management

TORONTO, June 6 /PRNewswire/ -- Dyadem, the market leader in Quality
Lifecycle Management and Risk Lifecycle Management solutions, has announced
that Genzyme Corporation, one of the world's leading biotechnology companies,
is using software from Dyadem to enhance the quality of the medical devices
produced in its Bio-surgery division. Dyadem's FMEA-Med, a software solution
that helps automate compliance reporting, enables Genzyme to link risk and
quality, and to set a new standard in quality throughout the lifecycle of its
biotherapeutic and biomaterial products. Genzyme's leading biomaterials and
cell therapies reduce the time and complications associated with surgery, and
in some cases, postpone the need for surgery.
FMEA-Med is a software solution that delivers industry-standard Failure
Mode and Effects Analysis (FMEA) reports for medical devices and
pharmaceutical manufacturers. FMEA methodology maintains quality and prevents
potential flaws in hardware design, manufacturing and processes in a variety
of industries, including pharmaceutical, automotive, and high tech and
electronics. Dyadem's FMEA-Med focuses on the entire quality lifecycle
management process, which is essential to the research and advancement of
these fields. The medical device industry must comply with FDA and ISO
standards among others.
With more than 300 employees spanning three sites in the United States,
Genzyme's Bio-surgery division now has a single standard for risk assessment.
As these multiple sites are subject to varying government and industry
regulatory standards, Genzyme's use of FMEA-Med creates a consistent quality
standard across the division to fulfill the varying requirements.
Prior to selecting Dyadem, Genzyme used manual templates for FMEA
assessments. Genzyme found that this approach led to inconsistencies in its
reporting, and that it provided insufficient focus on the entire quality
lifecycle. Dyadem's FMEA-Med provides a platform where clear relationships are
shown between failure modes, along with their causes and net effects. This
allows Genzyme to eliminate the time spent managing word processing documents,
and free employee time to focus on the technical content of risk assessments.
"In our industry, quality and risk management parameters are integrated
into all aspects of research, development, production and application, as our
products must perform flawlessly. Dyadem's software allows us to work in a
more uniform environment, and assess quality in a standard way. Our focus on
increasing quality and minimizing potential risks has, in turn, favorable
impact on time to market as well as reduce post-launch complaints," said Lisa
Robertson, Director, Design and Development, Quality Assurance.
By achieving the high standards of quality, minimizing the risk of defects
and reducing process administration, Dyadem is helping Genzyme maintain its
status as an industry leader in medical research and device production.
"Achieving reduced risk through a comprehensive standard of quality should
be at the top of the list for every company. In Genzyme's important industry
of developing life-saving technologies, there is no room for error," said
Kevin North, president and CEO of Dyadem. "Genzyme is setting an example by
highlighting the importance of quality lifecycle management. Our software
allows Genzyme to continue operating at an elite level to develop these
life-altering technologies in an environment with high quality standards."
About Dyadem
Founded in 1993, Dyadem is the market leader in Quality Lifecycle
Management and Risk Lifecycle Management solutions. Dyadem provides software
and services that empower companies to manage quality, mitigate risks, achieve
regulatory compliance, plan for business continuity and improve profitability.
Dyadem works with 85% of the Fortune 500 companies and serves the high tech &
electronics, medical devices, oil and gas, chemical, automotive,
pharmaceutical and aerospace and defense industries. For more information,
visit www.dyadem.com.
About Genzyme Corporation
One of the world's leading biotechnology companies, Genzyme Corporation is
dedicated to making a major positive impact on the lives of people with
serious diseases. Since 1981, the company has grown from a small start-up to a
diversified enterprise with more than 10,000 employees in locations spanning
the globe and 2007 revenues of $3.8 billion. In 2007, Genzyme was chosen to
receive the National Medal of Technology, the highest honor awarded by the
President of the United States for technological innovation.
With many established products and services helping patients in nearly 90
countries, Genzyme is a leader in the effort to develop and apply the most
advanced technologies in the life sciences. The company's products and
services are focused on rare inherited disorders, kidney disease,
orthopaedics, cancer, transplant, and diagnostic testing. Genzyme's commitment
to innovation continues today with a substantial development program focused
on these fields, as well as immune disease, cardiovascular disease, and other
areas of unmet medical need.
For further information, contact:

Dyadem International Ltd Text 100 Public Relations
Angela Schwecke Matt Wyman
905.762.5243 617.399.4919
aschwecke@dyadem.com dyadem@text100.com

SOURCE Dyadem

Angela Schwecke of Dyadem International Ltd, +1-905-762-5243,
aschwecke@dyadem.com, or Matt Wyman of Text 100 Public Relations,
+1-617-399-4919, dyadem@text100.com