Skip to main content
QMSQMS
QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
  • Records
    • 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
  • Licenses and accreditations
  • External documentation
  • Records
  • GP-002 Quality planning
  • R-002-007
  • R-002-007 Process validation card 2023_009

R-002-007 Process validation card 2023_009

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​

Human Resources

Requirements​

As we are not experts on risk prevention at work, we needed to contract an expert external risk prevention service to identify and mitigate workplace hazards and reduce the risk of accidents and injuries.

Selection description​

We have selected Prevenlabour as our external risk prevention service supplier as they provide us:

  • Expertise: Prevenlabour has expertise in workplace safety and risk management, and can provide advice and guidance to help us comply with regulations and best practices.

  • Risk Assessments: Prevenlabour can perform risk assessments to identify potential hazards in the workplace and provide recommendations for mitigating those risks.

  • Training: Prevenlabour provides training to employees on a wide range of topics related to workplace safety, such as ergonomics, fire safety, and first aid. This helps to reduce the risk of accidents and injuries.

  • Compliance: Prevenlabour helps us comply with relevant health and safety regulations, which can help to reduce the risk of fines and legal action.

  • Cost-Effective: Using an external risk prevention service like Prevenlabour is more cost-effective than hiring a full-time in-house safety professional, especially for small businesses like ours.

Validation​

Prevenlabour helps our company creating a safer and more productive workplace by providing expertise, risk assessments, training, compliance assistance, and cost-effective solutions.

Process approval​

Approved by

E-Signature (Appfire integration):

Signature logo

Andy Aguilar

5ED3F7B92096D73494A000B2BB9B4B07

Signer name: Andy Aguilar

Signing time: Wed, 08 Mar 2023 12:34:41 GMT

Reason: Process approval

JD-001 General Manager (GM)
Previous
R-002-007 Process validation card 2023_008
Next
R-002-007 Process validation card 2023_010
  • 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.)