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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
      • Templates
        • T-019-001 Software validation report_Software name_YYYY_nnn
        • T-019-002 External software list_YYYY_nnn
    • 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
    • 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-019 Software validation plan
  • Templates
  • T-019-002 External software list_YYYY_nnn

T-019-002 External software list_YYYY_nnn

External software list​

Software typeNameRisk ClassRisk JustificationPerformanceValidation activities
Risk Class Options
  • High-risk: Patient data, safety/performance impact, clinical decisions, regulatory implications → Full validation required
  • Non-high-risk: Business processes, QMS tools, indirect quality impact → Simplified validation or issue tracking
  • Non-risked: Infrastructure, generic office tools, no quality impact → Issue tracking only, no validation

Record signature meaning​

  • Author: JD-004 Author name
  • Reviewer: JD-003 or JD-005 Reviewer name
  • Approver: JD-001 Approver name

Template signature meaning​

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Delete this section when you create a new record from this template.

  • Author: JD-004 María Diez
  • Reviewer: JD-003 Taig Mac Carthy
  • Approver: JD-001 Andy Aguilar
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T-019-001 Software validation report_Software name_YYYY_nnn
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GP-020 QMS Data analysis
  • External software list
  • Record signature meaning
  • Template signature meaning
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.)