Compliance-First Approach and Quality Silos are Obstacles to Improving Product Quality
YARDLEY, PA & CHARLOTTE, N.C. (March 19, 2009) – Axendia Inc., a trusted advisor to life science executives and Camstar Systems today announced the availability of findings from a recently completed research study - Quality Management System Trends in Life Sciences.
The research study sponsored by Camstar Systems identified the impact of current Quality Management System (QMS) implementations in the life sciences industry and their effects on product quality, regulatory risk and adverse event exposure across the global enterprise.
Over 125 companies, covering small, mid-size, and Fortune 100 Life-Science organizations participated in the study. They represented the full spectrum of medical device, pharmaceutical, biotech and diagnostic organizations.
“The study revealed that many life science companies are employing reactive approaches to quality, using QMS primarily to manage and document compliance to FDA regulations,” commented Daniel R. Matlis, President of Axendia. “This compliance-first philosophy seems to be an obstacle to achieving real, long-lasting quality gains. Quality does not result from simply meeting regulatory requirements. Rather, compliance should be a natural outcome of executing well defined and understood processes,” Matlis added.
“Quality programs must ‘close the loop’ across all phases of the product life cycle — from design through manufacturing to field use — so the company can deliver the highest quality product, on time, the first time,” commented Karim Lokas, VP of Product strategy at Camstar. Manufacturers need to implement a fundamentally different approach to quality management. Rather than piecing together information from multiple and disparate CAPA, nonconformance, adverse event, manufacturing and design systems, the most effective manufacturers implement a closed-loop enterprise platform to create an end-to-end quality process that monitors events from all sources to identify potential problems before a quality issue occurs,” added Lokas.
Axendia and Camstar will share in-depth findings, analysis and conclusions from this research study in a series of online executive briefings beginning in mid March. View the briefings at: http://www.camstar.info/QMSbriefings.
About Axendia:
Axendia Inc. is a leading analysis firm focused on the Life-Sciences and Healthcare markets. The firm provides trusted advice to Life-Science Executives on Business, Regulatory and Technology issues. Axendia’s unique perspective is a result or our focus on the Life-Sciences and Healthcare markets and a unique blend of industry experience and strategic vision. This approach enables us to successfully identify, create and execute strategies which provide lasting business value for our clients. Additional information on Axendia’s can be found at www.Axendia.com
About Camstar Systems, Inc.
Camstar is a leading innovator of software solutions that advance product quality in the manufacturing industry, enabling its customers to deliver the highest quality products on time, the first time, every time. The Camstar Enterprise Platform advances product quality throughout the product lifecycle, from design to planning to supply to manufacturing to customer product experience – all in a closed-loop learning process that allows future products to be designed better and manufacturing processes to be leaner and more efficient.
Camstar is the largest in its market, including solutions for manufacturing execution, process planning, enterprise quality management, and manufacturing intelligence. For over 20 years, Camstar has served hundreds of satisfied customers worldwide, including Boston Scientific, Kodak, Zeiss, Life Technologies, Beijing SE Potevio Mobile Communications, ZOLL, CIBA Vision, AMD, BIOTRONIK, Hitachi, IBM and Eagle Test.
For more information, please visit www.camstar.com.