Most of us in the pharmaceutical and biopharmaceutical industry are very familiar with the terms corrective action & preventative action (CAPA) and commonly associate it exclusively with quality and manufacturing.

However, CAPA can be applied to many different business areas within an organization, including clinical research.  A CAPA consists of a collection of tasks and actions executed to ensure and sustain quality and compliance in day-to-day processes.  In clinical research, noncompliance can be extremely costly, both directly and indirectly. Continue reading →