Due to the extensive investment and long new product introduction / approval cycles, the pharmaceutical industry is very hesitant to make process changes and even improvements, for fear of triggering a re-submission. This has created a very risk-averse culture. CAPA systems will be challenged to be that much more thorough and to properly investigate root causes. Since changes are difficult to implement, it is that much more important to do it right the first time. Good CAPA systems can provide proper trending, and problem analysis so that the right root cause is identified.
