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  • Welcome to your QMS
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  • Legit.Health Plus Version 1.1.0.0
    • Index
    • Overview and Device Description
    • Information provided by the Manufacturer
    • Design and Manufacturing Information
      • R-TF-012-019 SOUPs
      • R-TF-012-030 Software Configuration Management Plan
      • Software Requirement Specification (SRS)
      • Product Requirement Specification (PRS)
      • R-TF-012-037 Labeling and IFU Requirements
      • deprecated
      • Usability engineering file
    • GSPR
    • Benefit-Risk Analysis and Risk Management
    • Product Verification and Validation
    • Design History File
    • Post-Market Surveillance
  • Legit.Health Plus Version 1.1.0.1
  • Licenses and accreditations
  • Applicable Standards and Regulations
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  • Legit.Health Plus Version 1.1.0.0
  • Design and Manufacturing Information
  • R-TF-012-030 Software Configuration Management Plan

R-TF-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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Software Requirement Specification (SRS)
  • 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.)