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QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
  • Records
  • Legit.Health Plus Version 1.1.0.0
  • Legit.Health Plus Version 1.1.0.1
  • Legit.Health Utilities
  • Licenses and accreditations
  • Applicable Standards and Regulations
  • BSI Non-Conformities
    • Technical Review
      • Round 1
        • M1: Diagnostic Function
          • Q1: IFU Performance Claims
          • Q2: Test Environment
            • Question
            • Research and planning
            • Response
          • Q3: Biofilm/Slough Verification
          • Q4: T377 Test Results
        • M2: Software V&V
        • N1: Information Supplied
        • N2: Usability
        • N3: Risk Management
    • Clinical Review
    • BSI Non-Conformities
  • Pricing
  • Public tenders
  • BSI Non-Conformities
  • Technical Review
  • Round 1
  • M1: Diagnostic Function
  • Q2: Test Environment
  • Response

Response

Root Cause​

The AI model integration tests for version 1.1.0.0 were executed using a localized client script interacting with our Preproduction cloud environment. While the software version under test was documented, the explicit hardware, software, and configuration specifications of both the client execution environment and the cloud infrastructure hosting the API were inadvertently omitted from the final Verification Test Report.

Correction​

We have updated the Software Test Report (R-TF-012-035-Software-Test-Report.mdx) to explicitly define the "System Under Test" (AWS EC2 Preproduction infrastructure, DynamoDB tables, and Docker container baseline) and the "Test Execution Environment" (Local Client hardware, OS, and Python configuration) used to generate the results in master.csv.

Furthermore, to guarantee absolute reproducibility, the updated report now explicitly documents:

  • Test Software Versioning: The custom integration script has been placed under strict version control, referencing the exact GitHub repository and commit SHA used during execution.
  • Test Data Versioning: The test dataset has been frozen as an immutable snapshot within our versioned S3 evidence bucket (v1.1.0.0).
info

The execution results previously referred to as master.csv during the audit have been formally archived in the QMS under the controlled nomenclature ai-models-integration-tests.csv, as referenced in Annex D.

Preventive Action​

The Software Test Plan (R-TF-012-033-Software-Test-Plan.mdx) has been updated to mandate that all future verification campaigns explicitly record both the client execution environment and the remote infrastructure baseline in the test report and evidence manifest.

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All the information contained in this QMS is confidential. The recipient agrees not to transmit or reproduce the information, neither by himself nor by third parties, through whichever means, without obtaining the prior written permission of Legit.Health (AI Labs Group S.L.)