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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_014

R-002-007 Process validation card 2023_014

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​

We need to find the best choice to comply with the General Data Protection Regulation (GPDR)

Selection description​

We have chosen to outsource our data protection responsibilities to Audens, that can offer several benefits to us, including:

  • Expertise: Audens is a specialized company that provides data protection services. They have the expertise and knowledge needed to ensure that our data is properly managed, secured, and compliant with relevant regulations.

  • Cost-Effective: Hiring a full-time data protection officer or building an in-house data protection team can be expensive. Outsourcing to a third-party vendor can be a more cost-effective option, especially for smaller companies or startups like us.

  • Reduced Risk: By outsourcing data protection responsibilities to Audens, our company can reduce the risk of data breaches and other security incidents. Audens can implement the necessary controls and procedures to ensure that our data is protected from unauthorized access, theft, or loss.

  • Flexibility: As a startup, our company may experience rapid growth or changes in its operations. Outsourcing to a third-party vendor like Audens provides us with the flexibility to adapt to these changes without having to worry about managing our data protection responsibilities in-house.

Validation​

Outsourcing data protection responsibilities to a third-party vendor like Audens help us to focus on our core business activities while ensuring that its data is properly managed, secured, and compliant with relevant regulations.

Process approval​

Approved by

E-Signature (Appfire integration):

Signature logo

Andy Aguilar

B703460534BCC3FD71A6A4E96D91E1A8

Signer name: Andy Aguilar

Signing time: Wed, 08 Mar 2023 14:31:21 GMT

Reason: Process approval

JD-001 General Manager (GM)
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  • Version control
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  • 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.)