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    • GP-001 Documents and records control
    • GP-002 Quality planning
      • Deprecated
      • R-002-007
        • R-002-007 Process validation card 2023_001
        • R-002-007 Process validation card 2023_002
        • R-002-007 Process validation card 2023_003
        • R-002-007 Process validation card 2023_004
        • R-002-007 Process validation card 2023_005
        • R-002-007 Process validation card 2023_006
        • R-002-007 Process validation card 2023_007
        • R-002-007 Process validation card 2023_008
        • R-002-007 Process validation card 2023_009
        • R-002-007 Process validation card 2023_010
        • R-002-007 Process validation card 2023_011
        • R-002-007 Process validation card 2023_012
        • R-002-007 Process validation card 2023_014
        • R-002-007 Process validation card 2023_015
        • R-002-007 Process validation card 2023_016
        • R-002-007 Process validation card 2023_017
        • R-002-007 Process validation card 2023_018
        • R-002-007 Process validation card 2024_001
        • R-002-007 Process validation card 2024_002
      • R-002-001 Quality objectives list_2024_001
      • R-002-001 Quality objectives list_2025
      • R-002-001 Quality objectives list_2026
      • R-002-002 Quality objectives_2024_001
      • R-002-002 Quality objectives_2024_002
      • R-002-002 Quality objectives_2024_003
      • R-002-002 Quality objectives_2024_004
      • R-002-002 Quality objectives_2024_005
      • R-002-002 Quality objectives_2025_001
      • R-002-002 Quality objectives_2025_002
      • R-002-002 Quality objectives_2025_003
      • R-002-002 Quality objectives_2025_004
      • R-002-002 Quality objectives_2025_005
      • R-002-002 Quality objectives_2026_001
      • R-002-002 Quality objectives_2026_002
      • R-002-002 Quality objectives_2026_003
      • R-002-002 Quality objectives_2026_004
      • R-002-002 Quality objectives_2026_005
      • R-002-003 Quality indicators
      • R-002-004 Annual management review report 2025
      • R-002-004 Annual management review report 2026
      • R-002-005 Quality Calendar_2025
      • R-002-005 Quality Calendar_2026
    • GP-003 Audits
    • GP-004 Vigilance system
    • GP-005 HR and training
    • GP-007 Post-market surveillance
    • GP-009 Sales
    • GP-010 Suppliers
    • GP-012 Design, Redesign and Development
    • GP-018 Infrastructure and facilities
    • GP-019 Non-product software validation
    • GP-023 Change control management
    • GP-050 Data Protection
    • GP-051 Security violations
    • GP-052 Data Privacy Impact Assessment (DPIA)
    • GP-200 Remote Data Acquisition in Clinical Investigations
    • GP-011 Provision of service
    • GP-110 Esquema Nacional de Seguridad
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  • GP-002 Quality planning
  • R-002-007
  • R-002-007 Process validation card 2023_011

R-002-007 Process validation card 2023_011

Version control​

Reason for reviewDateVersion idChange
Initial creation202303081N/A
Management Review 2024202404152Annual revalidation
Management Review 2025202504153Annual revalidation
Update202602234Added Docusaurus/Turborepo/Firebase and risk analysis section

Process​

Operations

Requirements​

To develop a Quality Management System and regulatory documentation (IFUs, Investigator Manuals) that allows accessibility, scalability, customization, security, version control and integration.

Selection description​

Developing a Quality Management System (QMS) and regulatory documentation as web applications offers several advantages for us:

  • Accessibility: By developing our QMS as a web-based application, it can be accessed from anywhere with an internet connection, which can be useful for remote teams or employees who need to access the system while on the go.

  • Scalability: A web-based application QMS can be easily scaled up or down as needed, without the need for physical infrastructure or hardware upgrades.

  • Customization: A webpage-based QMS can be easily customized to suit the specific needs of our organization, with different features and modules added or removed as needed.

  • Security: A webpage-based QMS can be secured using encryption, authentication, and access controls to protect sensitive information and prevent unauthorized access.

  • User-Friendly: A webpage-based QMS can be designed to be user-friendly and intuitive, with clear navigation and easily accessible resources and tools.

  • Integration: A webpage-based QMS can be integrated with other tools and systems, such as databases or reporting tools, which can help to streamline workflows and improve efficiency.

Additionally, we have chosen to use Git alongside Markdown programming language (to make it easy to read, write, and edit prose) to develop our quality management system as a web-based application, through the GitHub Microsoft tool selected (see R-002-007 Process validation card 2023_017), as it has the following characteristics:

  • Collaboration: GitHub enables team members to work on the same codebase simultaneously and merge changes together, facilitating collaboration and improving teamwork.

  • Version Control: GitHub provides a history of all changes made to the code, allowing developers to track the evolution of the code over time, identify bugs, and roll back to previous versions if needed.

  • Code Review: GitHub supports code review workflows, allowing other team members to review changes to the code and ensure they meet quality standards.

  • Branching: GitHub allows for the creation of branches, which can be used for development and testing of new features without affecting the main codebase. This can help to reduce risk and improve code quality.

  • Integration: GitHub can be integrated with other tools and services, such as continuous integration and deployment tools, which can help to automate the build and testing process and improve the efficiency of the development process.

  • Web Development: Using programming languages such as JavaScript, HTML, and CSS to develop our quality management system as a webpage can provide a user-friendly interface that can be accessed from anywhere with an internet connection.

Technical stack​

The following tools and frameworks are used to build and deploy our web-based documentation system:

ToolPurposeVersion
DocusaurusStatic site generator that transforms Markdown/MDX into web applications3.x
TurborepoMonorepo build system that manages multiple applications (QMS, IFUs, Investigator Manuals) in a single repositoryLatest
Firebase HostingCloud hosting platform for deploying Investigator Manuals with access controlN/A
Node.jsJavaScript runtime for building and running the applications18.x+

Docusaurus​

Docusaurus is a static site generator developed by Meta (Facebook) that converts Markdown and MDX files into fully functional web applications. Key characteristics:

  • Markdown/MDX support: Content is written in Markdown with React component support (MDX), enabling rich, interactive documentation while maintaining readability of source files.
  • Versioning: Built-in document versioning allows us to maintain multiple versions of IFUs and other regulatory documents.
  • Search: Integrated search functionality for easy navigation of documentation.
  • Internationalization (i18n): Native support for multiple languages, essential for EU IFUs requiring translations.
  • PDF generation: Integration with docs-to-pdf plugin enables generation of PDF versions for regulatory submissions.
  • Theming and customization: Fully customizable appearance to match branding requirements.
  • Active maintenance: Backed by Meta with regular updates and security patches.

Turborepo​

Turborepo is a high-performance build system for JavaScript/TypeScript monorepos. We use it to manage all our documentation applications in a single repository:

  • Monorepo structure: Single repository containing QMS, EU IFU (MDR/MDD), US IFU (FDA), Investigator Manuals, and Website.
  • Shared packages: Common components, styles, and configurations are shared across all applications, ensuring consistency.
  • Incremental builds: Only rebuilds what has changed, significantly reducing build times.
  • Task orchestration: Manages dependencies between build tasks across multiple applications.

The monorepo includes the following applications:

  • apps/qms - Quality Management System
  • apps/eu-ifu-mdr - EU Instructions for Use (MDR)
  • apps/eu-ifu-mdd - EU Instructions for Use (MDD)
  • apps/us-ifu-fda - US Instructions for Use (FDA)
  • apps/investigator-manual-* - Clinical study Investigator Manuals
  • apps/website - Public website

Firebase Hosting​

Firebase Hosting is used specifically for deploying Investigator Manuals that require access control:

  • Access control: Firebase Authentication integration enables restricted access to clinical study documentation.
  • HTTPS by default: All content served over secure connections.
  • Global CDN: Fast content delivery worldwide.
  • Easy deployment: Integrated with our CI/CD pipeline for automated deployments.

Validation​

Developing a QMS as a web-based application offers several advantages, including accessibility, scalability, customization, security, user-friendliness, and integration. By leveraging these advantages, we improve the efficiency and effectiveness of our quality management processes and ultimately deliver better products or services to our customers.

In addition, Git version control system allows us collaboration, version control, code review, branching, integration, and web development capabilities.

The technical stack (Docusaurus + Turborepo + Firebase) has been validated through:

  1. Continuous use since 2023: The system has been in production use, demonstrating stability and reliability.
  2. Regulatory submissions: Documentation generated by this system has been successfully used in regulatory submissions.
  3. Audit trail: Full version history maintained through Git, meeting 21 CFR Part 11 requirements (see R-002-007 Process validation card 2023_017).
  4. PDF generation: Validated capability to generate PDF outputs for regulatory submissions.

Identified risks​

RiskPotential impactControl measureStatus
Docusaurus major version update breaks compatibilityDocumentation build failurePin major versions, test updates in development branch before mergingControlled
Firebase service outageInvestigator manuals temporarily unavailableMonitor Firebase status, alternative PDF distribution availableControlled
Dependency vulnerabilitiesSecurity riskAutomated dependency scanning (Dependabot), regular updatesMonitoring

Record signature meaning​

  • Author: JD-004
  • Review and approval: JD-001 ㅤ ㅤ
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R-002-007 Process validation card 2023_010
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R-002-007 Process validation card 2023_012
  • Version control
  • Process
  • Requirements
  • Selection description
    • Technical stack
      • Docusaurus
      • Turborepo
      • Firebase Hosting
  • Validation
  • Identified risks
  • 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.)