CAPA (corrective actions and preventive actions) is the primary focus of US FDA during inspections. With reference to ICH Q10, CAPA is a structured approach to the investigation process and should be used with the objective of determining the root cause (detailed root cause analyses). This methodology should result in product and/or process improvement and it should enhance the product and process understanding.
Sarjen’s QEdge eQMS CAPA focuses on the systematic investigation of the root cause of identified risk or problem, correct the problem, and prevent them from recurring by helping user identify in taking appropriate, effective and comprehensive Corrective and/or Preventive Actions.
Sarjen’s QEdge eQMS assesses and monitors effectiveness of the such actions, in line with Quality Risk Management Principles and ensure the closure of CAPA after successful implementation.