Software CAPA Documentation

Quality Assurance
1

Hi Community,

Looking for Software CAPA documentation/ end-to-end process what are the challenges faced in the software CAPA side would be truly appreciated.

Thanks
Maddy

2

Hi @maddy,

High level steps in IT CAPA management:

  1. Exception/ incident/ deviation is reported
  2. Perform Impact Assessment
  3. Review and approve the Impact Assessment
  4. Perform Root Cause Analysis to identify the root cause
  5. Develop CAPA Plan with governance mechanism and define Effectiveness Check, as appropriate
  6. Review and approve the plan along with EC (Effectiveness Check)
  7. Execute the CAPA Plan
  8. Document the actions performed, outcomes with evidences
  9. Request Extension if required, providing justification
  10. Verify the completion of CAPA plan execution and document the results with objective evidence
  11. Measure the effectiveness of the same
  12. Review and approve the EC results
  13. Investigate to determine the root cause for the CAPA failure
  14. Impact level is the same as the original ER event
  15. Cycle is repeated until satisfactory/ acceptable results are achieved.