CAPA MANAGEMENT

AuditMan has simple but powerful CAPA module that includes all sub-processes required by ISO 13485:2016 and MDSAP regulators. These include root-cause analysis, traceability to internal, external, and supplier audit findings, risk categories, immediate actions, corrective actions and preventive actions, effectiveness checks, and non-conforming product disposition.

With AuditMan You Can:

 

Raise CAPA and NCR and follow up until closure

Gain full visibility on CAPAs/NCRs current status

Assign responsibilities, action items, and due dates

Assign criticality levels to CAPAs and NCRs

Conduct and report root-cause analysis

Have Access Control over all CAPA/NCR evidence

Streamline supplier nonconformances and corrective actions (SCARs)

Control disposition of non-conforming parts detected before or after delivery

Generate CAPA and NCR reports and statistics with 1 Click

Drive continuous improvement in your organisation

You can raise CAPAs and NCRs in AuditMan whether they originate from Internal Audits, External Audits, or Post-Market feedback. AuditMan then makes everything integrated.

Determine actions to be taken, assign responsibilities to personnel, and set deadlines. Attach action reports and the supporting evidence to tell the story.

You can raise CAPAs and NCRs in AuditMan whether they originate from Internal Audits, External Audits, or Post-Market feedback. AuditMan then makes everything integrated.

Determine actions to be taken, assign responsibilities to personnel, and set deadlines. Attach action reports and the supporting evidence to tell the story.