Unable to close NC raised during Audits? Maven has the solution
Audits can be either internal or external and are the main source of non-conformities. The audit findings are classified as major non-conformity, minor nonconformity, and Observations for improvement. These non-conformities raised during audits are resolved by taking appropriate corrective or preventive Action (CAPA).
CAPA investigations are carried out in a systematic manner that includes:
1. Finding the root cause of the problem
2. Suggesting Appropriate corrective or preventive action specific to the root cause
3. Implementing and verifying the effectiveness of action on QMS.
If non-conformities are not managed in a correct manner, it can become a nightmare. As most of the times, manufacturers accept weak corrective action resulting in the repetition of non-conformity.
Our AMC team performs in-depth investigations using various techniques to identify the root cause. We adopt a logical approach to solving the problem and provide evidence as a solution.
Our AMC team provides a permanent solution to it so that possibility of its future re-occurrence can be reduced or eliminated within your organization.
Contact us at [email protected] or +91 7490017774
#audit #Internal #external #CAPA #Implementation #solution #verifications #wearemaven #AMC #QMSupdates #auditsupport #regulatoryupdates #regulatoryaffairs #medicaldevices #cecertification #regulatoryconsultants #EUMDR #IVDR #ClinicalEvaluation