February 2015 Posts

Electronic MedWatch Reporting: eMDR Testing with CDRH (Free E-Book)

Electronic MedWatch Reporting: eMDR Testing with CDRH (Free E-Book)

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

A few months back, we hosted a webinar on the eMDR Countdown to Compliance during which we learned that from beginning to end, the transition to electronic medical device report submissions (electronic MedWatch or FDA Form 3500A reporting) can take between four to six months. But how do you really know that you’re ready to comply with the new mandate?

Today, let’s point the microscope at one piece of the puzzle: testing your electronic medical device report submissions with the FDA’s CDRH. Testing gives you the opportunity to identify and correct trouble areas before you transition to production electronic reporting. (more…)

Document Management in the Quality Fold: What You Should Know

Document Management in the Quality Fold: What You Should Know

Sandy Carson Hessen, Marketing Communications Manager, Pilgrim Quality Solutions

If you work in the Quality arena, you probably know that the effectiveness of a Quality Management System (QMS) relies extensively upon enterprise-wide collaboration and begins with a solid process for managing important documents, like standard operating procedures. But as rapidly as business and its processes evolve these days, many organizations struggle to stay current in a sea of change. So it’s not surprising that document management remains at the very top of quality management processes being automated within the highly regulated Life Sciences space. (more…)