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QMSQMS
QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
  • Records
    • GP-001 Documents and records control
    • GP-002 Quality planning
      • Deprecated
      • R-002-001 Quality objectives list_2024_001
      • R-002-001 Quality objectives list_2025
      • 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-002-003 Quality indicators_2024
      • R-002-004 Annual management review report
      • R-002-005 Quality Calendar_2025
      • R-002-006 SWOT and CAME analysis
      • 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-002-008 Quality and regulatory roadmap
      • R-002-009 Regulatory requirements review report
    • 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 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
  • TF_Legit.Health_Plus
  • Licenses and accreditations
  • External documentation
  • Records
  • GP-002 Quality planning
  • R-002-007
  • R-002-007 Process validation card 2023_011

R-002-007 Process validation card 2023_011

Process​

Operations

Requirements​

To develop a Quality Management System that allows accessibility, scalability, customization, security, version control and integration.

Selection description​

Developing a Quality Management System (QMS) as a web application 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.

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

Record signature meaning​

  • Author: JD-004 María Diez
  • Review and approval: JD-001 Andy Aguilar
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R-002-007 Process validation card 2023_010
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R-002-007 Process validation card 2023_012
  • Process
  • Requirements
  • Selection description
  • Validation
  • 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.)