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By Daniel R. Matlis  

Today, we are pleased to announce the availability of findings from our research study on “Quality Management System trends in Life Sciences”.This research study, sponsored by Camstar, 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 Sciences companies are employing reactive approaches to quality, using QMS primarily to manage and document compliance to FDA regulations. 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.

We are sharing in-depth findings, analysis and conclusions from this research study in a Research Alert and a series of online Executive Briefings.To read the Research Alert and view the first Executive Briefing in our series click on this link: http://lsp.axendia.com/qms-trends/

The FDA is currently shifting its organizational and technology infrastructures to facilitate electronic interactions with the companies it regulates.

Results from this Axendia research, commissioned by MasterControl, are now available in a Whitepaper entitled: The Future of the FDA: Operating in an “Electronic World”

This Whitepaper details FDA’s movement to electronic interactions and is based on interviews with key FDA officials who shared major transformational activities that:

• Promise to usher in a new era of electronic interactions between the FDA and its constituents 
• Move towards working in an environment where all regulated product information comes in electronically, whether it be product quality, manufacturing, pre-market, or post market data

To download The Future of the FDA: Operating in an “Electronic World” Whitepaper and read the accompanying FDA’s e-Transformation Initiatives article series visit: http://lsp.axendia.com/fda-e-transformation-study/

Findings and detailed analysis from this study will be presented at the INTERPHEX PharmaMedDevice Symposium scheduled for March 19, 2009 at 9:00AM (Session PMD14) at the Jacob K. Javits Convention Center in NY.