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  • Quality Manual
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    • GP-001 Documents and records control
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      • 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
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    • 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_003

R-002-007 Process validation card 2023_003

Version control​

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

Process​

Design and development

Requirements​

A integrated, agile, and customizable solution for software development.

Selection description​

We have chosen to use Atlassian tools, including Jira, Bitbucket, and Confluence, to produce our software medical device, as it allows us:

  • Integration: One of the biggest benefits of using Atlassian tools is the integration between the different platforms. Jira, Bitbucket, and Confluence are designed to work seamlessly together, which can make it easier to manage tasks, code repositories, and knowledge documentation in one centralized location.

  • Agile methodology support: Atlassian tools are designed to support agile software development methodologies, which can be a good fit for us that need to be flexible and adaptable. Jira, in particular, is a popular tool for agile task management, with features like scrum and kanban boards.

  • Customization options: Atlassian tools are highly customizable, which means that they can be tailored to our specific needs and workflows. This can be especially important for us that have unique requirements and processes that need to be accommodated.

  • Community support: Atlassian has a large community of users and developers, which can provide helpful resources and support as we work with the tools. There are also many third-party plugins and add-ons available for Atlassian tools, which can extend their functionality and capabilities.

Validation​

Atlassian tools is a great choice as the tools are designed to work well together and can be adapted to fit our specific needs and workflows. Additionally, the community support and availability of third-party plugins can be beneficial for us that we do not have extensive in-house resources.

We have been using this tool since we founded the company and have confirmed that it meets our requirements in a satisfactory manner.

Identified risks​

RiskPotential impactControl measureStatus
Service outage affecting development workflowTemporary inability to track tasks or access codeCloud-based with high SLA; local Git copies availableControlled

Record signature meaning​

  • Author: JD-004
  • Review and approval: JD-001

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 Design & Development Manager, JD-004 Quality Manager & PRRC
  • Approver: JD-001 General Manager
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  • Version control
  • Process
  • Requirements
  • Selection description
  • 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.)