Qualitas can help you establish a CAPA system or can assist you in maintaining an already established system. Qualitas can assist with the following:
- Writing Corrective and Preventative Actions.
- Providing pointers on preventative actions that can be implemented within your specific organization.
- Evaluating / determining root cause investigation and recommending short term and long term solutions.
- Monitoring the CAPA system to determine if trends are existing.
- Reviewing effectiveness of the CAPA system as a whole and determining the effectiveness of individual CAPAs.
- Providing written feedback to executive management on the state of the CAPA system along with recommendations.
Helpful Links: FDA and Medical Device Industry