QMS Trends

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.