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  • Welcome to your QMS
  • Quality Manual
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    • 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
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  • GP-002 Quality planning
  • R-002-007
  • R-002-007 Process validation card 2023_005

R-002-007 Process validation card 2023_005

Version control​

Reason for reviewDateVersion id
First version202303081

Process​

Operations

Requirements​

We require a work mode that allow us to make savings, better talent access, employees satisfaction and productivity increases .

Selection description​

We have decided that there are several benefits to working remotely that are relevant for us:

  • Cost savings: Without the need for a physical office space, we save on rent, utilities, and other expenses associated with maintaining a brick-and-mortar location.

  • Access to talent: Working remotely allows us to expand our pool of employees beyond those who live within commuting distance of a physical office. This can make it easier to find and hire top talent from anywhere in the world.

  • Flexibility: Remote work offer our employees more flexibility in terms of when and where they work. This helps with work-life balance and is especially appealing to employees who have family or other commitments.

  • Increased productivity: Some studies have suggested that remote workers may be more productive than those who work in a traditional office environment. This are due to factors like reduced distractions and the ability to work in a comfortable, personalized environment.

Validation​

Given the nature of the work we do, our culture and the preferences and need of our employees, we have obtained the satisfactory expected results with this work mode since we found the company.

Process approval​

Approved by

E-Signature (Appfire integration):

Signature logo

Andy Aguilar

5D13568D3C020357521142627F5EEAEC

Signer name: Andy Aguilar

Signing time: Wed, 08 Mar 2023 10:05:48 GMT

Reason: Process approval

JD-001 General Manager (GM)

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: JD-004
  • Reviewer: JD-001
  • Approver: JD-001
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  • Version control
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  • Requirements
  • Selection description
  • Validation
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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.)