The ideal of proactive quality has become the holy grail of the Chief Quality Officer in the life sciences industry but few, if any, have realized the vision.
Industry has since set out a clear definition of the milestones a medical product manufacturer would need to meet in order to achieve proactive quality as a differentiator. Many of those are cultural but the majority required quality technology and innovation to reach the disruptive levels they have today. Quality 4.0 is defined as the application of Industry 4.0’s advanced digital technologies to enhance traditional best practices in quality management. With the advent of such innovations as AI and IoT in the quality management ecosystem, the promise of proactive quality is finally a reality. Today the industry faces unprecedented challenges but also opportunities to serve the patient like never before; both of which require innovation in their business and product as well as in their approach to quality. This paper will illuminate those challenges and opportunities, the reasons why recognizing and embracing bi-modality is so vitally important and how quality technology is a critical enabler for life sciences companies under these unique pressures.
STEPHEN MCCARTHY
Vice President, Digital Innovation
