Effective Corrective and Preventive Action is about identifying key areas of processes to manage, and then reducing the variation associated with these processes.

Having an ineffective Corrective and Preventive Action (CAPA) system in place in a company that manufactures health care products potentially represents a significant risk to patients and the organization’s compliance profile.

For example, for companies that supply products for use in the USA, more than 80% of Warning Letters issued by FDA contain a reference to inadequacies in the CAPA system.

We can assist in all areas of CAPA system management, from writing procedures, to training and implementation, to carrying out remediation in areas where effective action has not been able to be demonstrated.