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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
  • TF_Legit.Health_Plus
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  • GP-002 Quality planning
  • R-002-007
  • R-002-007 Process validation card 2023_001

R-002-007 Process validation card 2023_001

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​

Operations

Requirements​

A collaborative, accessible, and cost-effective file management system.

Selection description​

We have chosen to use Google Drive as our file management system, as it allows us:

  • Collaboration: Google Drive is known for its collaboration features. Since our company has four founders working remotely, we need a file management system that allows us to work together on documents and files in real-time. Google Drive allows multiple users to edit and comment on documents simultaneously, making collaboration much more efficient.

  • Accessibility: Since Google Drive is a cloud-based storage solution, it's accessible from anywhere with an internet connection. This means that our team can access the files they need from anywhere, at any time. Additionally, files can be easily shared with people outside of our organization, such as investors or clients.

  • Cost-effective: Google Drive is a cost-effective solution compared to other file management systems. It offers a certain amount of storage for free and charges reasonable prices for additional storage if needed.

  • Integration with other Google products: As our company uses other Google products, such as Gmail or Google Calendar, using Google Drive can help streamline our workflow. It's easy to share files and folders from Google Drive directly within Gmail, for example, without needing to download or upload attachments.

Validation​

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

DD064512AB7103227A11566E6411D729

Signer name: Andy Aguilar

Signing time: Wed, 08 Mar 2023 08:59:08 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.)