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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
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  • Legit.Health Plus Version 1.1.0.1
  • Licenses and accreditations
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  • Procedures
  • GP-012 Design, redesign and development
  • Templates
  • T-012-028 Software Requirement Specification

T-012-028 Software Requirement Specification

Identifier​

Instructions

Unique identifier of the Software Requirement (SR)

Software system​

Instructions

Name of the software system to which the Software Requirement (SR) belongs. This is the software system that is being developed or maintained.

  • App
  • Backend
  • Load balancer

Category​

Instructions

The Software Requirement (SR) category as regard to the IEC 62304

  • Functional
  • Input and output, interfaces
  • Security
  • User interface
  • Data definition and databases
  • Regulatory
  • Maintenance
  • Installation
  • Alarms, warnings, and messages You can select more than one if applicable.

Description​

Instructions

Detailed text describing the Software Requirement (SR)

Related activities​

Instructions

List of activities related to the Software Requirement (SR) that are defined in the Software Development Procedure and linked to Jira activities.

Derived from PRS​

Instructions

Indicates from which Product Requirement Specification (PRS) the Software Requirement (SR) is derived. This is a reference to the PRS document.

Risk control measure​

Instructions

Indicates whether the Software Requirement (SR) serves as a risk control measure to mitigate or eliminate an identified risk. The value is 'Yes' if the SR is specifically implemented as a risk control, and 'No' otherwise

Creates risk ID​

Instructions

This column lists the unique identifiers of risks that are generated as a result of the implementation or existence of the corresponding Software Requirement (SR)

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T-012-026 Product Validation Phase 5 Checklist
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T-012-029 Software Architecture Description
  • Identifier
  • Software system
  • Category
  • Description
  • Related activities
  • Derived from PRS
  • Risk control measure
  • Creates risk ID
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.)