CAPA (corrective actions and preventive actions) is the primary focus of regulatory bodies 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. Transforming to online CAPA Management Software makes it easy to manage CAPA activities.
Sarjen’s QEdge EQMS 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.
CAPA Management Software assesses and monitors effectiveness of such actions, in line with Quality Risk Management Principles and ensure the closure of CAPA after successful implementation.
The risk-based Corrective and Preventive Action (CAPA) requirements need a properly documented system that defines the root cause of non-conformances, system outages or process problems, rectifies the problems, and prevents them from recurring. QEdge’s CAPA Management Software is integrated with risk management to provide you more insight into risk detection and corresponding prioritization with appropriate action plans.
QEdge’s CAPA Management also helps reduce the Cost of Quality (CoQ) within your organization to improve product quality by implementing a continuously improving QMS system.