Response
Acknowledgment & Root Cause Analysis:
We acknowledge the auditor's finding regarding the incorrect evidence provided for the 'Biofilm/Slough Surface' integrated model verification. Upon investigation, we identified that the root cause was a clerical error during the manual recording of test results in our test management tool (TestRail). Specifically, the S3 URI link pasted into the evidence field incorrectly pointed to the 'wound bed' test evidence rather than the 'Biofilm/Slough Surface' evidence.
Impact Assessment:
We have assessed the impact of this error and determined it is strictly a traceability and documentation issue. It does not affect the safety, performance, or actual integration of the 'Biofilm/Slough Surface' model within the API.
Correction (Immediate Action Taken):
To correct this issue, the following actions have been completed:
- The integration test for the 'Biofilm/Slough Surface' model has been re-executed.
- A new, correct evidence pack has been generated and successfully uploaded to our S3 repository.
- The evidence URI field in TestRail has been updated to point to the correct evidence package.
Note: Within the attached C515_T355.zip archive, the response.json file now correctly reflects the Biofilm/Slough Surface output, directly addressing the excerpt noted in the audit finding.
Evidence Provided for Review:
Please find attached for the corrected evidence:
- Updated TestRail Export/Report: showing the corrected S3 URI. See R-TF-012-035 Software Test Report for the updated test report reflecting the correct evidence link. You can also download from the direct link below: Download Updated TestRail Report
- Corrected Evidence Pack, located at
s3://legit-health-plus/software-tests/v1.1.0.0/integration-verification/wound-biofilm-segmenter/case-001/evidence/. Download link: Download Corrected Evidence
Preventive Action:
We are evaluating changing the way of how we do the linking between our CI/CD pipeline and TestRail to eliminate this type of error in the future.