February 2011 Posts

Compliance is Nothing More than Risk in Sheep’s Clothing

Regulatory requirements around the world have grown, creating heavy workloads of documentation and the need for process transparency.  In addition to rising compliance concerns, Life Sciences organizations face increased security measures, including HIPAA, FDAA 2007 and more.

Regulatory risk is the possibility of being out of compliance. For many Life Sciences companies, regulations rule your compliance objectives. How you handle it is based on your product, production processes and your level of tolerance for risk. A high tolerance for risk might equate to lower compliance costs, but potentially higher non-compliance penalties.

An Argument for Continuous Improvement

An Argument for Continuous Improvement

Let’s say your company has been error-free for years. You pass every audit. You achieve all certifications. You have the ideal quality processes in place. Have you then reached a Quality Apex? You can go no higher?

Perhaps your company isn’t that perfect, but you feel that you have quality under control. You catch defects before they leave the plant. You might have an infraction or two from a regulations standpoint but you easily remedy the situation. Are you also in a position where your quality efforts have reached a plateau? (more…)

Medical Device Recalls: Creating a Balance

Right now, there are some 6.6 billion people in the world, and over the next 30 years, it will soar to over 9 billion. At the same time, the global population is aging, and mostly so in the U.S. and Europe. As the population ages, health care needs will likely increase, leading to an increase in medical device consumption, an industry currently valued at $290 billion dollars. (Kalorama Information, A division of MarketingResearch.com). The U.S. represents the largest medical device market with $130 billion dollars in revenues. (more…)