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QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
    • GP-001 Control of documents
    • GP-002 Quality planning
    • GP-003 Audits
    • GP-004 Vigilance system
    • GP-005 Human Resources and Training
    • GP-006 Non-conformity, Corrective and Preventive actions
    • GP-007 Post-market surveillance
    • GP-008 Product requirements
    • GP-009 Sales
    • GP-010 Purchases and suppliers evaluation
    • GP-011 Provision of service
    • GP-012 Design, redesign and development
    • GP-013 Risk management
    • GP-014 Feedback and complaints
    • GP-015 Clinical evaluation
    • GP-016 Traceability and identification
    • GP-017 Technical assistance service
    • GP-018 Infrastructure and facilities
    • GP-019 Software validation plan
    • GP-020 QMS Data analysis
    • GP-021 Communications
    • GP-022 Document translation
    • GP-023 Change control management
    • GP-024 Predetermined Change Control Plan
    • GP-025 Usability and Human Factors Engineering
    • GP-027 Corporate Governance
    • GP-028 AI Development
      • Specific procedures
        • T-TF-028-001 AI Description
        • T-TF-028-002 AI Development Plan
        • T-TF-028-003 Data Collection Instructions
        • T-TF-028-004 Data Annotation Instructions
        • T-TF-028-005 AI Development Report
        • T-TF-028-006 AI Release Report
        • T-TF-028-007 AI Retraining Report
        • T-TF-028-008 AI Reevaluation Report
        • T-TF-028-009 AI Design Checks
        • T-TF-028-010 AI V&V Checks
        • T-TF-028-011 AI Risk Assessment
    • GP-029 Software Delivery and Commissioning
    • GP-030 Cyber Security Management
    • GP-050 Data Protection
    • GP-051 Security violations
    • GP-052 Data Privacy Impact Assessment (DPIA)
    • GP-100 Business Continuity (BCP) and Disaster Recovery plans (DRP)
    • GP-101 Information security
    • GP-200 Remote Data Acquisition in Clinical Investigations
    • GP-026 Market-specific product requirements
    • GP-110 Esquema Nacional de Seguridad
  • 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
  • Pricing
  • Public tenders
  • Procedures
  • GP-028 AI Development
  • Specific procedures
  • T-TF-028-010 AI V&V Checks

T-TF-028-010 AI V&V Checks

Table of contents
  • Purpose
  • Instructions
  • Checklist
    • R-TF-028-005 AI Development Report
    • R-TF-028-006 AI Release Report
    • Algorithm Package Verification
    • Risk Assessment Integration
    • Traceability
  • Conclusion
  • Release Authorization
  • Verification

Purpose​

This checklist is used to verify that the Verification & Validation Phase of the AI development lifecycle has been completed in accordance with procedure GP-028 AI Development. It ensures that the AI Development Report and AI Release Report are complete, all performance criteria have been met, and the algorithm package is ready for integration into the target software environment.

Instructions​

The verifier must assess each item in the checklist. For each item, select "Yes," "No," or "N/A" and provide comments where necessary, especially for any "No" answers. All "No" items must be resolved before the V&V Phase can be considered complete and the algorithm package can be released.

Checklist​

R-TF-028-005 AI Development Report​

Check ItemYes/No/NAComments
1. Is the data management process fully documented and traceable?
2. Is the training methodology comprehensively described for each model?
3. Are performance results presented with appropriate statistical measures (e.g., confidence intervals)?
4. Do all models meet their predefined performance criteria as specified in R-TF-028-001?
5. Has bias analysis been conducted across relevant subpopulations?
6. Are bias analysis results acceptable for all subgroups?
7. Has the test set been properly sequestered and used only for final evaluation?

R-TF-028-006 AI Release Report​

Check ItemYes/No/NAComments
1. Are all models included in the release package documented?
2. Are input/output specifications clearly defined for each model?
3. Are preprocessing requirements fully specified?
4. Are post-processing requirements fully specified?
5. Are configuration files complete and correct?
6. Are integration guidelines sufficient for the software development team?
7. Is the model file format appropriate and documented (e.g., ONNX version)?

Algorithm Package Verification​

Check ItemYes/No/NAComments
1. Are all model files present and accessible?
2. Are all configuration files present and valid?
3. Do model versions match the documentation?
4. Have the models been tested for basic functionality (inference runs without errors)?
5. Is the package versioned and stored in the designated repository?

Risk Assessment Integration​

Check ItemYes/No/NAComments
1. Has the AI Risk Matrix (R-TF-028-011) been updated based on development findings?
2. Are all residual risks at acceptable or tolerable levels?
3. Have safety risks related to AI been communicated to the product team?

Traceability​

Check ItemYes/No/NAComments
1. Is there clear traceability from requirements (R-TF-028-001) to test results?
2. Are all design decisions documented and justified?
3. Are all data sources traceable and documented?

Conclusion​

State the overall outcome of the V&V check.

☐ V&V Phase Approved: All checks have been successfully passed. The algorithm package is cleared for release to the software development team.

☐ V&V Phase Not Approved: One or more checks have failed. The responsible team members must address the comments and resubmit the documentation for verification.

Overall Comments:

Provide any summary comments or required actions here.

Release Authorization​

ItemValue
Package Version
Release Date
Repository Location

Verification​

Signature meaning

The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:

  • Author: JD-009
  • Reviewer: JD-009
  • Approver: JD-005
Previous
T-TF-028-009 AI Design Checks
Next
T-TF-028-011 AI Risk Assessment
  • Purpose
  • Instructions
  • Checklist
    • R-TF-028-005 AI Development Report
    • R-TF-028-006 AI Release Report
    • Algorithm Package Verification
    • Risk Assessment Integration
    • Traceability
  • Conclusion
  • Release Authorization
  • Verification
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.)