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  • 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
      • Deprecated
      • Templates
        • T-012-004 Software version release
        • T-012-005 Design change control
        • T-012-006 _Product name_ life cycle plan and report_YYYY_nnn
        • T-012-007 Formative evaluation plan_YYYY_nnn
        • T-012-008 Formative evaluation report_YYYY_nnn
        • T-012-009 Validation and testing of machine learning models_YYYY_nnn
        • T-012-010 Device backup verification_YYYY_nnn
        • T-012-012 Customers product version control_YYYY_nnn
        • T-012-013 Design stage review
        • T-012-014 Summative evaluation plan_YYYY_nnn
        • T-012-015 Summative evaluation report YYYY_nnn
        • T-012-016 Software usability test guide
        • T-012-017 Integration test review
        • T-012-019 SOUP
        • T-012-020 Predetermined Change Control Plan
        • T-012-021 Product Design Phase 1 Checklist
        • T-012-022 Software Design Phase 2 Checklist
        • T-012-023 Software Development Plan
        • T-012-024 Software Candidate Release Phase 3 Checklist
        • T-012-025 Software Verification Phase 4 Checklist
        • T-012-026 Product Validation Phase 5 Checklist
        • T-012-028 Software Requirement Specification
        • T-012-029 Software Architecture Description
        • T-012-030 Software Configuration Management Plan
        • T-012-031 Product Requirements Specification
        • T-012-033 Software Tests Plan
        • T-012-034 Software Test Description
        • T-012-035 Software Test Run
        • T-012-037 Labeling and IFU Requirements
        • T-012-038 Verified Version Release
        • T-012-039 Validated Version Transfer
        • T-012-040 Documentation level FDA
        • T-012-041 Software Classification 62304
        • T-012-042 Regulatory Requirement
        • T-012-043 Traceability Matrix
      • GP-012 [Old version] Design, Redesign and Development
      • Specific procedures
    • 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 Cybersecurity Risk Management
    • GP-025 Usability and Human Factors Engineering
    • GP-027 Corporate Governance
    • GP-028 AI Development
    • GP-029 Software Delivery And Comissioning
    • 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
  • Public tenders
  • Procedures
  • GP-012 Design, redesign and development
  • Templates
  • T-012-043 Traceability Matrix

T-012-043 Traceability Matrix

A traceability matrix serves as a bridge between risks, requirements and testing activities, ensuring that all risks/requirements are adequately mitigated and covered by test cases. The traceability matrix shows forward traceability, that is splitted in 3 parts, linking Risks to SRS mitigation, PR to SRS and finally SRS to Test Cases.

Its purpose :

  • Coverage Verification: ensures that all requirements are tested and that no requirements are overlooked.
  • Traceability: establishes a clear link between requirements and test cases, facilitating easier analysis and debugging.
  • Risk Mitigation: helps identify risks and their mitigations, detects gaps in testing coverage.

Risks and SRS/RR mitigation​

Risk mitigation traceability involves establishing a clear connection between identified risks in a project and the corresponding software requirements specifications (SRS) or regulatory requirements (RR). This ensures that appropriate mitigation strategies are in place to address potential risks and ensure project success. Additionally, this matrix highlights the links between the risks themselves, providing a comprehensive overview and facilitating the management of interdependencies

Issue TypeKeySummaryLinked Issues.linkTypeIssueTypeissueKeyIssueSummary

SRS and TestCase​

SRS and Test Case Traceability is a critical aspect of software quality assurance that ensures all software requirements are adequately tested. It establishes a clear link between the requirements specified in the Software Requirements Specification (SRS) and the test cases designed to verify those requirements.

Software Requirement

Test Case

Medical device v1.1.0.0 RC1

Medical device v1.1.0.0 RC2

Medical device v1.1.0.0 RC3

Issue TypeKeySummaryLinkTypeTestCase SummaryTest ResultsCommentsTest ResultsCommentsTest ResultsComments
Software RequirementSRS-001
Software RequirementSRS-001
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T-012-042 Regulatory Requirement
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GP-012 [Old version] Design, Redesign and Development
  • Risks and SRS/RR mitigation
  • SRS and TestCase
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