The ECA Academy shared that in 2016, most GMP inspection deficiencies involved quality systems—more specifically, the Corrective and Preventive Action (CAPA) process.
A closer look revealed that root cause analysis and impact assessment are still a challenge for many organizations. These organizations struggle with taking measures to prevent recurrence of adverse events.
A possible explanation for this challenge is that organizations are not leveraging leading and lagging indicators to their advantage when building corrective action management processes.
Learning to understand leading and lagging metrics and how to use them in your organization can be a gamechanger in the Life Sciences.