May 2013

For Medical Device Companies

Avoiding Remediation with a Good QMS

by: Walt Murray, Director of Quality and Compliance Services, MasterControl Inc.

Many companies will try to resolve compliance actions by the Food and Drug Administration (FDA) through the use of an electronic data management system (EDMS) approach that is typically post mortem. This is risky business at two critical levels. First, no EDMS approach will replace the operation of a comprehensive quality management system (QMS) that describes the integration of necessary GxP (compliance) driven quality processes. Secondly, the response will need to have a litany of justifications for a retrospective systematic approach. This is like trying to perform process validation on pre-existing production of unqualified products: it’s bad business!

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How Social Media Is Advancing Healthcare

by: Laurie Meehan, Internal Project Manager, Polaris Compliance Consultants, Inc.

Facebook’s IPO last year received a lot of media attention. While the news was mostly financial, the huge sums of money being discussed were not the only numbers associated with the social networking site that can give pause. Facebook now boasts more than a staggering 1 billion users. To put that in perspective, that’if Facebook were a country, it would be the 3rd largest in the world. And while Facebook is the biggest, it’s not the only social networking giant. Depending what source you consult and how you count, there’s another dozen or so social media sites with 100,000,000 or more active users. It’s hard to believe that, as little as seven years ago, Facebook was still in its infancy, unavailable to the general public, and many of the other popular sites didn’t yet exist. Journalist Tom Friedman humorously observed that, “way back then”, Twitter was just a sound, the Cloud was something in the sky, applications were something you sent to college, and Skype was a typo.

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Ways to Ensure Supplier Compliance

by: Cindy Fazzi, Marketing Communications Specialist, MasterControl Inc.

Your suppliers are critical to your success. They can increase your company’s efficiency—in terms of time, cost, and quality. But in some cases, suppliers can put their clients in hot water; this is especially true if those clients are regulated companies.

For example, Epimed International, a medical device company, received a warning letter from the U.S. FDA for quality violations involving its supplier. The FDA said in a 2012 warning letter that Epimed conducts acceptance testing on the radio frequency of thermocouple electrodes without knowledge of the device manufacturer’s original specifications from the initial manufacturer, or how changes made to the device (e.g., sterilization cycles) will affect the device.

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