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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
  • External documentation
  • Public tenders
  • Procedures
  • GP-012 Design, redesign and development
  • Templates
  • T-012-030 Software Configuration Management Plan

T-012-030 Software Configuration Management Plan

Object​

Instructions

Briefly describe the purpose of this document. Explain that it is part of the Technical File and outlines the software configuration management strategy for the product. Mention the target software or device.

Scope​

Instructions

Define the boundaries of the document. Indicate which product or software it applies to, and mention that it should be updated and reviewed in case of design or development changes.

Contents​

Instructions

List all the main sections of the document in order. This works as a table of contents. Include every major heading used throughout the plan.

Abbreviations, Terms & Definitions​

Instructions

List and define any abbreviations, technical terms, or specific definitions used in the document to ensure clarity and consistency for all readers.

References​

Project References​

Instructions

List internal documents or plans that this document refers to or depends on. Include their identifiers if applicable.

Standard and Regulatory References​

Instructions

List all applicable standards and regulations (e.g. IEC 62304) that influence the software configuration management processes.

Conventions​

Instructions

Specify naming conventions, formatting rules, or any other stylistic rules used throughout the document, especially for code repositories or documentation (e.g. Git branch naming).

Organization​

Instructions

Explain the overall structure and tools used for configuration management (e.g., Git, Jira, Bitbucket). Mention responsibilities, workflows, and any relevant policies or protocols.

Configuration Management Principles​

Instructions

Detail the types of branches used (feature, release, bug), naming conventions, merge policies, and how these align with your issue tracking system. Provide concrete examples.

Configuration Management in a Development Cycle​

Instructions

Describe how configuration management is integrated into each development phase. Include the Pull Request (PR) workflow, continuous integration steps, reviewer roles, and merge conditions.

Releases Configuration Management​

Instructions

Explain how releases are tracked, tagged, and documented in the version control system. Mention Semantic Versioning rules and any required documentation or tagging practices.

Prototypes Configuration Management​

Instructions

If applicable, explain how prototype builds or experimental versions are managed. If not applicable, state so explicitly.

Tasks in Development and Maintenance​

Instructions

Describe typical tasks and responsibilities during development and maintenance. Mention how these tasks impact configuration management (e.g., updates to source code or documentation).

Archiving Versions​

Instructions

Detail how release candidates and final releases are archived (e.g., Google Drive folder structure). Specify what types of files are stored and where.

Link Between Source Control and Bugs/Features​

Instructions

Describe how Git commits, branches, and PRs are linked to issues in the tracking system (e.g., Jira). Include examples of naming and commit message formats.

Configuration Identification​

Configuration Items Identification Rules​

Instructions

Define the rules for naming and versioning configuration items, using Semantic Versioning. Include the format for release names, pre-release tags, and build metadata.

SOUP Identification Rules​

Instructions

Specify the naming/versioning convention for identifying SOUPs (Software Of Unknown Provenance), including what elements should be included in the identifier.

Installer Identification Rules​

Instructions

Describe how the installer for the software is identified and distributed. If no installer is used, indicate that clearly.

Archives Identification Rules​

Instructions

Indicate how archives (if any) are named and managed. If not applicable, state that explicitly.

Documents Identification Rules​

Instructions

Describe the naming convention used to identify documents, including versioning scheme.

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T-012-029 Software Architecture Description
Next
T-012-031 Product Requirements Specification
  • Object
  • Scope
  • Contents
  • Abbreviations, Terms & Definitions
  • References
    • Project References
    • Standard and Regulatory References
    • Conventions
  • Organization
    • Configuration Management Principles
    • Configuration Management in a Development Cycle
    • Releases Configuration Management
    • Prototypes Configuration Management
    • Tasks in Development and Maintenance
    • Archiving Versions
    • Link Between Source Control and Bugs/Features
  • Configuration Identification
    • Configuration Items Identification Rules
    • SOUP Identification Rules
    • Installer Identification Rules
    • Archives Identification Rules
    • Documents Identification Rules
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.)