Companies must have a system for implementing corrective actions and preventive actions that arise from non-conformances, customer complaints, product failures, product recalls, process deviations, audits, regulatory inspections and trends from process performance and product quality monitoring.

PSC can help you develop a structured approach to the investigation process with the objective of determining and correcting the root cause of the issue as well as preventing recurrence. We can assist you in the development implementation of a CAPA system that focuses on investigations that are commensurate with the level of risk associated with the issue, in line with ICH Q9.

If you have a need for our CAPA services, please Contact Us.