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  • Quality Manual
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    • GP-001 Documents and records control
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      • 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
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    • GP-007 Post-market surveillance
    • GP-009 Sales
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    • 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
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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 id
First version202303081
Written byReviewed byApproved by

E-Signature (Appfire integration):

Signature logo

María Diez

6E206A2F15299C7C6E416D11903F365C

Signer name: María Diez

Signing time: Sun, 05 Mar 2023 08:34:18 GMT

Reason: Creation of document

E-Signature (Appfire integration):

Signature logo

Alfonso Medela

DA66021199574C5989D8B451B63DC242

Signer name: Alfonso Medela

Signing time: Tue, 07 Mar 2023 08:46:40 GMT

Reason: Reviewed

E-Signature (Appfire integration):

Signature logo

Andy Aguilar

694DA2B1C7AC8395560124C183EB13EE

Signer name: Andy Aguilar

Signing time: Wed, 08 Mar 2023 08:45:48 GMT

Reason: Approving document

Quality manager (QM)Technical manager (PRRC)General manager (GM)

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.

Process approval​

Approved by

E-Signature (Appfire integration):

Signature logo

Andy Aguilar

A541AC19470A4739C9A95A364270A205

Signer name: Andy Aguilar

Signing time: Wed, 08 Mar 2023 09:32:28 GMT

Reason: Process approval

JD-001 General Manager (GM)
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  • Version control
  • Process
  • Requirements
  • Selection description
  • Validation
  • Process approval
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.)