Quality events in controlled environment are normally resulted in CAPA for management and control of untoward events. Complaints, deviations, OOS and OOT are normally resulted in CAPA.
QEdge provides complete and transparent life cycle management of CAPA with full traceability on the source and implementation effectiveness.
QEdge, as a CAPA management software also offers in-built flexibility to design and implement the system in such a way, that in-between processes and work-flow within the organization can be customised under generic CAPA management software solution. Such CAPA management software helps organization to make sure all measures, identified in the past to solve issue or complaint related to quality are take care off and helps to make sure that same types of issues are not repeated.
Each corrective and preventive actions can have it’s own change management requirements. The closed loop quality management system within QEdge allows users to create change management through change control or CRF and help to monitor the same. CAPA would not be closed unless the change control associated with CAPA are confirmed to be closed.
CAPA management is an essential part of any closed loop and effective quality management system. Having electronic system as a CAPA management software establish that all diagnosed and recommended corrective and preventive actions are implemented in the processes and prevents repetition of such issues.