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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
      • 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
      • 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-012-019 SOUP

T-012-019 SOUP

Description​

Instructions

Insert a brief description of the SOUP.

General details​

  • Developer(s):
  • Open source:
  • Language(s):
  • Repository:
  • License:
  • Operating system(s):
  • Actively maintained:
    • Yes
    • No

Intended use on the device​

Instructions

Insert the intended use of the SOUP used in the medical device.

Requirements​

For the integration and safe usage of this SOUP within a software system, it's important to outline both functional and performance requirements. These requirements help mitigate risks and ensure compatibility and performance standards are met.

Functional​

Instructions

Insert the functional requirements of the SOUP.

Performance​

Instructions

Insert the performance requirements of the SOUP.

System requirements​

Establishing minimum software and hardware requirements is important to mitigate risks, such as security vulnerabilities, performance issues, or compatibility problems, and to ensure that the SOUP functions effectively within the intended environment.

Software​

Instructions

Insert any software requirements to enable the use of the SOUP.

Hardware​

Instructions

Insert any hardware requirements to enable the use of the SOUP.

Documentation​

Instructions

Insert the location of the SOUP documentation.

Additionally, a criterion for validating the SOUP is that all the items of the following checklist are satisfied:

  • The vendor maintains clear and comprehensive documentation of the SOUP describing its functional capabilities, user guidelines, and tutorials, which facilitates learning and rapid adoption.
  • The documentation for the SOUP is regularly updated and clearly outlines every feature utilized by the medical device, doing so for all integrated versions of the SOUP.

Related software items​

We catalog the interconnections between the microservices within our software architecture and the specific versions of the SOUP they utilize. This mapping ensures clarity and traceability, facilitating both the understanding of the system's dependencies and the management of SOUP components.

Although the title of the section mentions software items, the relationship with SOUP versions has been established with microservices (also considered software items) because each one is inside a different Docker container and, therefore, has its own isolated runtime environment.

SOUP versionSoftware item(s)

Related risks​

The following are risks applicable to this SOUP coming from the document R-TF-013-002 Risk management record:

Instructions

Insert the risk(s) ID and description related to the SOUP.

List of published anomalies​

Instructions

List the known anomalies related to the SOUP.

History of evaluation of SOUP anomalies​

  • Evaluation date: YYYY-MM-DD
  • Reviewer of the anomalies:
  • Version(s) of the SOUP reviewed:
  • Anomalies:

Signature meaning

The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:

  • Author: Team members involved
  • Reviewer: JD-003, JD-004
  • Approver: JD-001
Delete this

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

Signature meaning

The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:

  • Author: Team members involved
  • Reviewer: JD-003, JD-004
  • Approver: JD-001
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T-012-018 Test plan
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T-012-020 Predetermined Change Control Plan
  • Description
  • General details
  • Intended use on the device
  • Requirements
    • Functional
    • Performance
  • System requirements
    • Software
    • Hardware
  • Documentation
  • Related software items
  • Related risks
  • List of published anomalies
  • History of evaluation of SOUP anomalies
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.)