Addressing The Challenges Of Complaint Handling, Investigations, And Adverse Event Reporting

By Sparta Systems, Inc.

Quality is an ever-growing problem in the fields 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 firms 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.

It is true that regulatory bodies across the globe impose regulations and guidelines for manufacturers in the managing, reporting and resolution of complaints, investigations and adverse events. However, many of these companies simply haven't invested heavily enough in their quality staff s, systems and procedures to ensure quality products and practices. This has to change in order to better protect patients, manufacturers and investors.

The best combined, proactive solution is to refine testing, higher quality manufacturing and to implement a holistic quality management program across the entire product development lifecycle.