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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
  • Legit.Health Plus Version 1.1.0.0
  • Legit.Health Plus Version 1.1.0.1
  • Licenses and accreditations
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  • Records
  • GP-002 Quality planning
  • R-002-007
  • R-002-007 Process validation card 2023_015

R-002-007 Process validation card 2023_015

Version control​

Reason for reviewDateVersion id
First version202303081

Process​

Design and development

Requirements​

We need a scalable, reliable, secure, cost-effective solution for our computing infrastructure.

Selection description​

We have chosen to use Amazon Web Services (AWS), one of the leading cloud computing platforms, for our infrastructure needs as it has the following characteristics:

  • Scalability: AWS allows businesses to easily scale our infrastructure up or down depending on our needs. This means that we can start small and gradually expand our infrastructure as we grow, without having to worry about hardware limitations or capacity planning.
  • Reliability: AWS has a highly reliable infrastructure that is designed to minimize downtime and provide high availability to its users. AWS offers a Service Level Agreement (SLA) that guarantees a certain level of uptime, which can be particularly important for a medical device startup like us that needs to ensure its services are always available.
  • Security: AWS has a robust security infrastructure that is designed to protect its users' data and applications. AWS offers a range of security features and compliance certifications that can help us meet industry-specific security requirements.
  • Cost-effective: AWS offers a pay-as-you-go pricing model, which means that we only pay for the resources we use. This can be particularly beneficial for a startup like us that is looking to minimize its upfront costs and optimize its infrastructure spending.
  • Innovation: AWS is known for its constant innovation, with new services and features being released regularly. This can be particularly beneficial for us that need to stay up-to-date with the latest technologies and trends in cloud computing.

Validation​

AWS provides us a scalable, reliable, secure, cost-effective, and innovative infrastructure solution and covers all of our needs.

Process approval​

Approved by

E-Signature (Appfire integration):

Signature logo

Andy Aguilar

674D5B55E506FB2D028E1DAB390B6F7A

Signer name: Andy Aguilar

Signing time: Wed, 08 Mar 2023 15:38:01 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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R-002-007 Process validation card 2023_016
  • 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.)