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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
      • Deprecated
      • Templates
        • T-012-001 Requirements
        • T-012-003 Test run
        • 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-012-018 Test plan
        • 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-012-027 Version delivery description
        • 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-012-032 SOUP Name
        • T-012-033 Software Tests Plan
        • T-012-034 Software Test Description
        • T-012-035 Software Test Run
        • T-012-036 Software development plan
      • 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
    • GP-025 Usability and Human Factors Engineering
    • GP-027 Corporate Governance
    • 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
  • External documentation
  • Procedures
  • GP-012 Design, Redesign and Development
  • Templates
  • T-012-032 SOUP Name

T-012-032 SOUP Name

Description​

Instructions

Provide a general description of the SOUP. Include its purpose, provider, key features, and any compatibility notes. Mention whether it is open source or proprietary, and its general use case.

General details​

Instructions

Fill in key metadata for the SOUP:

  • Developer or provider
  • Whether it's open source
  • Supported programming languages
  • Repository (if available)
  • License type
  • Operating system compatibility
  • Maintenance status (is it actively maintained?) Use bullet points for clarity.

Intended use on the device​

Instructions

Describe the specific use of the SOUP within the medical device. Mention how and where it is integrated (e.g., for data storage, communication, authentication, etc.). Be specific and aligned with the device’s architecture.

Requirements​

Functional​

Instructions

List the functional requirements the SOUP must fulfill (e.g., compatibility, scalability, security, backup). Describe what the software must be able to do to support its use in the device.

Performance​

Instructions

Specify expected performance characteristics: availability, durability, throughput, latency, etc. Focus on measurable criteria that affect system reliability and responsiveness.

System requirements​

Software​

Instructions

Indicate any necessary software dependencies or configurations required for the SOUP to function. If none, state that clearly.

Hardware​

Instructions

Indicate any specific hardware requirements. If the SOUP runs on standard environments without special hardware, state that explicitly.

Documentation​

Instructions

Include a link to the official documentation. Then, provide a checklist or criteria to validate that the documentation is adequate:

  • Is it clear and comprehensive?
  • Is it regularly updated?
  • Does it cover all the features used in your device?

Related software items​

Instructions

Map the version(s) of the SOUP to specific software items or microservices that use it. Use a table format: | SOUP version | Software item(s) | If each microservice uses its own isolated instance (e.g., Docker), clarify that.

Related risks​

Instructions

List the risks related to using this SOUP, referencing your official risk management document. Use bullet points or numbers and ensure each risk is clearly described (e.g., maintenance, vulnerabilities, incompatibility).

Lists of published anomalies​

Instructions

Provide links to the SOUP's official changelogs, release notes, or incident tracking systems to monitor bugs, patches, or anomalies.

History of evaluation of SOUP anomalies​

Instructions

List past evaluations of the SOUP for known issues. For each entry include:

  • Date of review
  • Name of the reviewer
  • Versions evaluated
  • Summary of findings (e.g., no anomalies found) Repeat for each date/version as needed.

Record signature meaning​

Instructions

Define the roles and identifiers of the people involved:

  • Author (person who wrote the record)
  • Reviewer (person who verified the content)
  • Approver (person who approved it for formal inclusion)
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T-012-031 Product Requirements Specification
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T-012-033 Software Tests Plan
  • Description
  • General details
  • Intended use on the device
  • Requirements
    • Functional
    • Performance
  • System requirements
    • Software
    • Hardware
  • Documentation
  • Related software items
  • Related risks
  • Lists of published anomalies
  • History of evaluation of SOUP anomalies
  • Record 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.)