Quality is an ever-growing problem in the fi elds of pharmaceutical, medical devices, medical diagnostics and biologics, and its negative impact is signifi cantly palpable to manufacturers as well as their patients, employees and investors. Furthermore, as the globe’s dependence on medicine continues to heighten, as does the trend toward pervasive personalized medicine, the quality reigns are getting harder for many fi rms to hold on to. While some of this is due to poor products, a large amount can be attributed to inadequate quality reporting infrastructure on behalf of the manufacturers.