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    • GP-001 Documents and records control
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    • GP-007 Post-market surveillance
    • GP-009 Sales
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    • GP-012 Design, Redesign and Development
      • R-012-004 Software version release for Brazil
      • R-012-010 Device backup verification_2023_001
      • R-012-010 Device backup verification_2024_001
      • R-012-012 Customers product version control
      • R-012-017 Integration test review
    • GP-018 Infrastructure and facilities
    • GP-019 Software validation
    • GP-023 Change control management
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    • GP-200 Remote Data Acquisition in Clinical Investigations
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  • GP-012 Design, Redesign and Development
  • R-012-010 Device backup verification_2024_001

R-012-010 Device backup verification_2024_001

Evidence​

Date​

20241112 (YYYYMMDD)

Responsible​

JD-005 Alfonso Medela

Evidence​

Environment Setup​

To ensure a reproducible test environment:

  • A clean working directory was established to prevent conflicts.
  • The git repository was inspected to confirm the starting state.

Commit history

Repository Reversion​

The repository was reverted to the previous commit (SHA: d2b0d656da701cfa202fd0c134fda5d544e3e046) to validate the backup state.

Commit history Commit history

The repository was then restored to the latest commit to proceed with the build process.

Device Compilation​

The medical device, configured as a Dockerized application, was compiled using the appropriate Docker build command.

Commit history

Device Deployment and Validation​

The compiled device was launched, and connectivity was verified through the designated server port.

Commit history

The device responded as expected, confirming the backup and restoration processes were successful.

Commit history

Conclusion​

The backup verification test was completed successfully, with the medical device demonstrating the expected behavior post-reversion and recompilation. All steps adhered to procedure GP-012.

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, JD-004
  • Approver: JD-005
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R-012-010 Device backup verification_2023_001
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R-012-012 Customers product version control
  • Evidence
    • Date
    • Responsible
    • Evidence
      • Environment Setup
      • Repository Reversion
      • Device Compilation
      • Device Deployment and Validation
      • Conclusion
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.)