Poorly Defined CAPA Process
Defining the CAPA process is often a
huge issue especially for the medical
device’s companies. Companies, in
fact, don’t have any idea about
managing the CAPA process effectively.
The root cause of ineffective CAPA
process lies in its poor-definition of the
resources and actions.
You must make sure that the CAPA
process is appropriately defined and
communicated to your employees or
the people involved so that right
action(s) can be taken at right time
through a well-structured workflow.