There can be one or many Corrective Actions and Preventive Actions linked to a Deviation. The single
CAPA action is assigned to a Task Owner and a due date is estimated. Every CAPA is accepted individually
but is approved together with the associated Deviation. The CAPA is linked To the Deviation or Incident and each action can be linked to an activity closing for the CAPA action, i.e. a Change Request. The CAPA Management workflow within MyBlueLabel are as follows: Create CAPA, Review Internal, Review Independent, Approval for Realization, and CAPA Accepted.
Each corrective action will be tracked in the system. Each action will be approved and linked to an activity closing to ensure an optimum quality assurance of the proposed solution.
Preventive actions must be established in order to make sure the incident or deviation will not happen again. This activity is often associated with a gap in the procedures or processes and how they are implemented in the organization.
Having the full overview and control of actions will make it less complicated to implement and constantly improve harmonized and structured standard operations procedures throughout the company.
Modules in MyBlueLabel QMS Software
MyBlueLabel has a suite of modules to support the full ecosystem of processes to comply with regulations and international standards. The modules are integrated or can work as standalone modules.