Audits are an essential part of the Life Sciences as they ensure manufacturers are producing safe products and operating within compliance.
Previously, audits meant surprise business interruptions for manufacturers and a lot of travel and administrative work for auditors. With many Life Science manufacturers operating internationally, they were being audited separately to satisfy the requirements of each country in which they operated. At the end of the day, there was a lot of repeat work on both ends.
So regulatory agencies and legislators have come together to develop single audit programs that create comprehensive audits that satisfy the requirements of multiple countries. This creates a globally harmonized and efficient international audit management system.
One of the major programs is the Medical Device Single Audit Program (MDSAP). As the deadlines for these changes approaches quickly, here are 3 things that medical device manufacturers should know about the MDSAP.