Below is an article by Freer and Fiene (in press) to be published in the Journal of Regulatory Science this month that describes the need to balance regulatory compliance and quality addressing the constraints and opportunities for integration. It provides a unique perspective on how to develop this delicate balancing act.

Management systems for regulatory compliance and quality programs are examined in this paper from the standpoint of their potential integration and in terms of the concept of a process. The paper identifies five common drags on management system optimization and outlines a scoring system that organizations may use to evaluate their management systems for potential adoption of an integrated process-based program.