Corrective and Preventive Action
Get a well defined problem statement to start the root cause analysis
Define CAPA acceptance criteria together with the CAPA actions
Set up clear due dates to keep the CAPA on track
The corrective action process is one of the most critical processes in a quality system. Doing corrective actions right and effectively, requires a well structured process and support in execution.
Corrective and Preventive Action
Start new containment for issues discovered during root cause analysis
Built a comprehensive action plan for identified root causes
Execute verification of effectiveness according to approved methods
To improve the likelihood of an effective CAPA, every step in the process must be done thoroughly and with an inclusive perspective on the problem.
Best choice for CAPA
Novunex has designed world class CAPA systems for large enterprises
Previously implemented CAPA systems have stood up to the challenge of many inspections
Novunex has performed many peer reviews to find the best CAPA methodology
Managing CAPAs with Novunex
CAPAs are only initiated after they have been approved by the CAPA board
System helps to improve CAPA execution times by providing clear due dates and up to date progress reporting
System improves accountability with clear assignments and captures review and action approvals
Quality Managers carry a great deal of responsibility in ensuring that our respective organizations maintain regulatory compliance while also exhibiting a robust quality culture. They simply provided what was needed and made recommendation that ultimately made sense for our business needs.
We have gone through one ISO 13485 surveillance audit and our auditor was very happy and impressed with how the system works. The system has also helped us improve our traceability, and having more robust records.
The customer support is unmatched in the eQMS industry and the system is very flexible, and encompasses all manufacturing quality processes above and beyond the standard document control offerings.