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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-002-007
        • 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-002-001 Quality objectives list_2024_001
      • R-002-001 Quality objectives list_2025
      • R-002-001 Quality objectives list_2026
      • 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-002-002 Quality objectives_2026_001
      • R-002-002 Quality objectives_2026_002
      • R-002-002 Quality objectives_2026_003
      • R-002-002 Quality objectives_2026_004
      • R-002-002 Quality objectives_2026_005
      • R-002-003 Quality indicators
      • R-002-004 Annual management review report 2025
      • R-002-004 Annual management review report 2026
      • R-002-005 Quality Calendar_2025
      • R-002-005 Quality Calendar_2026
    • 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 Non-product 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
    • GP-011 Provision of service
    • GP-110 Esquema Nacional de Seguridad
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  • GP-002 Quality planning
  • R-002-007
  • R-002-007 Process validation card 2023_016

R-002-007 Process validation card 2023_016

Version control​

Reason for reviewDateVersion idChange
Initial creation202303081N/A
Management Review 2024202404152Annual revalidation
Management Review 2025202504153Annual revalidation
Update202602234Added risk analysis section

Process​

Design and development

Requirements​

We need a secure password management tool that allows collaboration within our team and external parties, and audit and control fuctionalities.

Selection description​

We have chosen to use 1Password, for our password management needs as it has the following characteristics:

  • Strong Security: 1Password is renowned for its robust security measures. It uses end-to-end encryption to ensure that our passwords and sensitive information are securely stored and protected. Additionally, it offers features like two-factor authentication (2FA) and advanced encryption algorithms, making it difficult for unauthorized individuals to access our data.
  • Convenience and Simplicity: 1Password provides a user-friendly interface and offers seamless integration across various devices and platforms. It simplifies the process of managing and accessing passwords by securely storing them in a centralized vault. Users can access their passwords and other confidential information quickly and easily, without the need to remember multiple complex passwords.
  • Enhanced Productivity: By eliminating the need to remember and manually enter passwords, 1Password saves time and increases productivity. It can automatically fill in login credentials for websites and applications, streamlining the login process and allowing our team to focus on their work rather than dealing with password-related hassles.
  • Collaboration Features: As a remote team, collaboration is essential. 1Password offers features that enable secure password sharing and team management. We can share passwords and other sensitive information with specific team members, granting them access as needed. This simplifies onboarding processes and ensures that the right individuals have access to the required credentials.
  • Secure Sharing with External Parties: In some cases, we may need to share passwords with external contractors, partners, or clients. 1Password allows for secure password sharing outside our organization while maintaining control over access privileges. This ensures that sensitive information is shared securely without compromising security.
  • Audit and Control: 1Password provides tools for administrators to monitor and control access to passwords and other shared resources. We can track who accessed which passwords, when they were accessed, and even revoke access if necessary. These auditing capabilities help maintain accountability and ensure that password-related activities are transparent.
  • Mobile Support: In today's mobile-centric world, having password management capabilities on mobile devices is crucial. 1Password offers mobile apps for iOS and Android, allowing our team to securely access their passwords and other important information on the go.
  • Regular Updates and Support: 1Password regularly releases updates to enhance security, improve functionality, and address any potential vulnerabilities. They also provide reliable customer support, ensuring that we have assistance when needed.

Validation​

1Password provides us a strong security, user-friendly interface, collaboration features, and robust support for managing the passwords, covering all of our needs.

Identified risks​

No significant risks identified for this process. 1Password uses enterprise-grade encryption and security measures.

Record signature meaning​

  • Author: JD-004
  • Review and approval: JD-001

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: Team members involved
  • Reviewer: JD-003 Design & Development Manager, JD-004 Quality Manager & PRRC
  • Approver: JD-001 General Manager
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R-002-007 Process validation card 2023_015
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R-002-007 Process validation card 2023_017
  • Version control
  • Process
  • Requirements
  • Selection description
  • Validation
  • Identified risks
  • Record signature meaning
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.)