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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
      • Templates
        • T-012-019 SOUP
        • 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-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
    • 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-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.

Part 1: Risk Traceability to Software Requirements​

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

Part 2: Product Requirements to Software Requirements​

Product Requirements (PR) to Software Requirements Specification (SRS) traceability is a crucial aspect of software development that ensures all product requirements are accurately translated into detailed software requirements. This traceability matrix helps in maintaining alignment between what the product aims to achieve and how the software is designed to fulfill those goals.

Product requirementSoftware Requirement

Part 3: Software Requirements (SRS) to Test Cases​

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-013 Risk management
  • Part 1: Risk Traceability to Software Requirements
  • Part 2: Product Requirements to Software Requirements
  • Part 3: Software Requirements (SRS) to Test Cases
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.)