Skip to main content
QMSQMS
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
    • GP-029 Software Delivery and Commissioning
      • Templates
        • T-029-001 Software Commissioning Plan
        • T-029-002 Software Commissioning Report
        • T-029-002 - Use Case Specification – Validation
    • 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
  • Licenses and accreditations
  • Applicable Standards and Regulations
  • Grants
  • Pricing
  • Public tenders
  • Procedures
  • GP-029 Software Delivery and Commissioning
  • Templates
  • T-029-002 - Use Case Specification – Validation

T-029-002 - Use Case Specification – Validation

1. Identifier​

  • UC ID: [e.g., VAL-UC-001]
  • Title: [Short name]

2. Purpose and Coverage​

  • Intended use requirements covered: [List IDs/phrases from use requirements]
  • Validation scope: [Functions/features exercised]

3. Method & Acceptance​

  • Validation method: [inspection / analysis / simulation / test / demo]
  • Input information (test data, configurations): [Datasets, configs]
  • Objective acceptance criteria: [Measurable pass/fail rules]

4. Enablers & Environment​

  • Operating environment(s): [HW/SW platforms, versions]
  • IT-NETWORK specifics (if applicable): [Required network characteristics, security specs, info flows]

5. Roles & Independence​

  • Validation personnel: [Role/qualification required]
  • Independence level: [separate person/management/org]

6. Preconditions & Setup​

  • Preconditions: [SW release ID, accompanying docs available]
  • Configuration: [Security options, interfaces, supported platforms as configured]

7. Procedure​

  • Steps: [Numbered steps to execute the case]
  • Data capture: [Logs, messages, outputs to retain]

8. Risks & Constraints​

  • Known limitations/constraints impacting feasibility: [e.g., data availability, load]
  • IT-NETWORK hazardous situations considered: [List or reference]

9. Traceability​

  • Links: [Use requirement ID(s) → system requirement(s) → this UC]

10. Expected Evidence​

  • Results to record: [Conditions, outcomes, anomalies, team members]
  • Residual risk status: [Criterion to confirm acceptability]

11. Deviation & Re-validation Rules​

  • Deviation handling: [How to justify/log deviations in report]
  • Anomaly handling & re-validation trigger: [When to repeat affected parts]
Previous
T-029-002 Software Commissioning Report
Next
GP-030 Cyber Security Management
  • 1. Identifier
  • 2. Purpose and Coverage
  • 3. Method & Acceptance
  • 4. Enablers & Environment
  • 5. Roles & Independence
  • 6. Preconditions & Setup
  • 7. Procedure
  • 8. Risks & Constraints
  • 9. Traceability
  • 10. Expected Evidence
  • 11. Deviation & Re-validation Rules
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.)