Risk Management

When evaluating an automated QMS, the question to invest in configuration vs. out-of-the-box (OOTB) is a core functional consideration. Should you configure your own processes, use an OOTB [...]

EU Medical Device Regulation (MDR) has been in effect for almost a year. As anticipated, the regulation has proven to be as challenging as the industry expected it would be. Now, companies also [...]

In recent months, the U.S. Food and Drug Administration (FDA) has issued a dozen warning letters over Foreign Supplier Verification Program (FSVP) violations. These food industry FSVP violations [...]