CAPAs and

Identify and resolve quality events, prevent recurrence,
and drive continuous improvement

CAPA process Flow 110723


Companies need a documented and effective non-conformance and CAPA process to identify and investigate quality events:

  • Trigger corrective actions to address the root cause of a problem

  • Prevent similar issues from occurring in the future

  • Maintain compliance with ISO 13485:2016 and FDA regulations

But without a right-sized approach to the non-conformance process, developers risk being swamped with Corrective Action reports or not triggering CAPAs enough to keep control of quality.

Don't just take our word for it.

How Cognidox helps

Cognidox provides NCR and CAPA reporting templates and workflows that can meet rigorous ISO standards and FDA regulations while keeping your process Lean, flexible and effective.

  • Easy-to-configure forms and workflows for complaints, non-conformances and CAPAs
  • Eliminate defects and stop recurrence through effective investigation and analysis
  • Assess risk and categorise NCRs to trigger CAPA investigations when appropriate
  • Identify and document non-critical OFI (Opportunities for Improvement) - to help optimise processes in the future
  • Automate processes and reminders to keep key stakeholders in the loop throughout investigations
  • Ensure fixes are verified and followed up for effectiveness
  • Capture essential data to analyse quality trends and drive continuous improvement
  • Enable proactive monitoring of quality to prevent product and process failures
  • Ensure complete traceability of every quality event

See Cognidox in action

Book a no obligation live 60-minute demo and discover if Cognidox is the right fit for your business.