6 Jun 2008
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.”