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QMSQMS
QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
    • GP-001 Control of documents
    • GP-002 Quality planning
      • Specific procedures
      • Templates
        • Deprecated
        • T-002-001 Quality objectives list
        • T-002-002 Quality objectives
        • T-002-003 Quality indicators
        • T-002-004 Anual management review report
        • T-002-005 Quality Calendar_YYYY_nnn
        • T-002-007 Process validation card
    • GP-003 Audits
    • GP-004 Vigilance system
    • GP-005 Human Resources and Training
    • GP-006 Non-conformity, Corrective and Preventive actions
    • GP-007 Post-market surveillance
    • GP-009 Sales
    • GP-010 Purchases and suppliers evaluation
    • GP-011 Provision of service
    • GP-012 Design, redesign and development
    • GP-013 Risk management
    • GP-014 Feedback and complaints
    • GP-015 Clinical evaluation
    • GP-016 Traceability and identification
    • GP-017 Technical assistance service
    • GP-018 Infrastructure and facilities
    • GP-019 Non-product software validation
    • GP-020 QMS Data analysis
    • GP-021 Communications
    • GP-022 Document translation
    • GP-023 Change control management
    • GP-024 Predetermined Change Control Plan
    • GP-025 Usability and Human Factors Engineering
    • GP-026 Market-specific product requirements
    • GP-027 Corporate Governance
    • GP-028 AI Development
    • GP-029 Software Delivery and Commissioning
    • GP-030 Cyber Security Management
    • GP-031 Training Data Governance
    • GP-050 Data Protection
    • GP-051 Security violations
    • GP-052 Data Privacy Impact Assessment (DPIA)
    • GP-100 Business Continuity (BCP) and Disaster Recovery plans (DRP)
    • GP-101 Information security
    • GP-110 Esquema Nacional de Seguridad
    • GP-200 Remote Data Acquisition in Clinical Investigations
  • Records
  • Legit.Health Plus Version 1.1.0.0
  • Legit.Health Plus Version 1.1.0.1
  • Legit.Health Utilities
  • Licenses and accreditations
  • Applicable Standards and Regulations
  • BSI Non-Conformities
  • Pricing
  • Public tenders
  • Procedures
  • GP-002 Quality planning
  • Templates
  • T-002-007 Process validation card

T-002-007 Process validation card

Version control​

Reason for reviewDateVersion id
First versionYYYYMMDD1

Process​

Insert process area: Operations / Design and development / Sales / Human Resources / Leadership / Customer satisfaction

Requirements​

Describe the key requirements that this process/tool must fulfill.

Selection description​

Explain why this tool/method/person was selected and how it meets the requirements.

Validation​

State the validation conclusion and evidence that the process meets requirements.

Identified risks​

Per ISO 13485:2016 clause 4.1.2.b, identify potential risks that could affect this process. If no significant risks are identified, state "No significant risks identified for this process."

RiskPotential impactControl measureStatus

Status options: Controlled / Monitoring / Action required

Record signature meaning​

  • Author: JD-XXX
  • 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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T-002-005 Quality Calendar_YYYY_nnn
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GP-003 Audits
  • 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.)