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QMSQMS
QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
    • GP-001 Control of documents
    • GP-002 Quality planning
    • 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-008 Product requirements
    • GP-009 Sales
    • GP-010 Purchases and suppliers evaluation
    • GP-011 Provision of service
    • GP-012 Design, redesign and development
      • Deprecated
      • Templates
        • T-012-004 Software version release
        • T-012-005 Design change control
        • T-012-006 _Product name_ life cycle plan and report_YYYY_nnn
        • T-012-007 Formative evaluation plan_YYYY_nnn
        • T-012-008 Formative evaluation report_YYYY_nnn
        • T-012-009 Validation and testing of machine learning models_YYYY_nnn
        • T-012-010 Device backup verification_YYYY_nnn
        • T-012-012 Customers product version control_YYYY_nnn
        • T-012-013 Design stage review
        • T-012-014 Summative evaluation plan_YYYY_nnn
        • T-012-015 Summative evaluation report YYYY_nnn
        • T-012-016 Software usability test guide
        • T-012-017 Integration test review
        • T-012-019 SOUP
        • T-012-020 Predetermined Change Control Plan
        • T-012-021 Product Design Phase 1 Checklist
        • T-012-022 Software Design Phase 2 Checklist
        • T-012-023 Software Development Plan
        • T-012-024 Software Candidate Release Phase 3 Checklist
        • T-012-025 Software Verification Phase 4 Checklist
        • T-012-026 Product Validation Phase 5 Checklist
        • T-012-028 Software Requirement Specification
        • T-012-029 Software Architecture Description
        • T-012-030 Software Configuration Management Plan
        • T-012-031 Product Requirements Specification
        • T-012-033 Software Tests Plan
        • T-012-034 Software Test Description
        • T-012-035 Software Test Run
        • T-012-037 Labeling and IFU Requirements
        • T-012-038 Verified Version Release
        • T-012-039 Validated Version Transfer
        • T-012-040 Documentation level FDA
        • T-012-041 Software Classification 62304
        • T-012-042 Regulatory Requirement
        • T-012-043 Traceability Matrix
      • GP-012 [Old version] Design, Redesign and Development
      • Specific procedures
    • 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 Software validation plan
    • GP-020 QMS Data analysis
    • GP-021 Communications
    • GP-022 Document translation
    • GP-023 Change control management
    • GP-024 Cybersecurity Risk Management
    • GP-025 Usability and Human Factors Engineering
    • GP-027 Corporate Governance
    • GP-028 AI Development
    • GP-029 Software Delivery And Comissioning
    • 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-200 Remote Data Acquisition in Clinical Investigations
    • GP-026 Market-specific product requirements
    • GP-110 Esquema Nacional de Seguridad
  • Records
  • Legit.Health Plus Version 1.1.0.0
  • Legit.Health Plus Version 1.1.0.1
  • Licenses and accreditations
  • External documentation
  • Public tenders
  • Procedures
  • GP-012 Design, redesign and development
  • Templates
  • T-012-026 Product Validation Phase 5 Checklist

T-012-026 Product Validation Phase 5 Checklist

Actors​

NameTitleMeaningApproved Date & Time

Change history​

RevisionSummaryDate

Process overview​

The purpose of the Product Validation Phase 5 Checklist review is to ensure the Product satisfy the criteria listed in the next section

Project information​

  • Project title:
  • Project manager (name and function):

Planning​

PhaseObjectDone
Phase 1 Product Design ReviewEstablish input data
Phase 2 Software Design ReviewSRs, Architectural Design and UI Prototypes
Phase 3 Software Candidate ReleaseCoding, integration and test plan
Phase 4 Software Verification ReviewSoftware version verified and residual anomalies
Phase 5 Product Validation ReviewValidation activities, Technical Documentation and DHF

Previous reserves​

Instructions

If there were any reserves or outstanding issues identified during Phase 2, list them here. Include a brief description of each reserve, the actions required to address them, and assign an owner and targeted completion date. See T-012-024 Software Candidate Release Phase 3 Checklist for an example.

N°Documents / Purpose / Actions to implementOwnerTargeted DateSatisfying

Outputs review​

ObjectRecords & CommentsSatisfyingReserves see
Version Delivery Description
Clinical Evaluation plan
Clinical Evaluation report
Clinical Investigation report
Usability Report
AI/ML Evaluation Report
Risk Management Report
Cybersecurity Report
DMF is updated
Validated version transfer
Labeling and IFU Requirements

Regulatory requirement review​

KeySummaryDescriptionSatisfyingReserves

Reserves​

N°Documents / Purpose / Actions to implementOwnerTargeted Date

Comissioning​

  • Reference of the commissioning record?:
  • Does the software version behave as expected on the production environment?: yes/no
  • If not, what are the actions taken?:

Conclusion​

Distribution countries​

Comments​

  • Does the IFU and labelling contains all expected informations?: yes/no
  • Approval for the product certification and registration?: yes/no
  • Regarding the mentioned reserves, has the review been accepted?: yes/no
Previous
T-012-025 Software Verification Phase 4 Checklist
Next
T-012-028 Software Requirement Specification
  • Actors
  • Change history
  • Process overview
  • Project information
  • Planning
  • Previous reserves
  • Outputs review
  • Regulatory requirement review
  • Reserves
  • Comissioning
  • Conclusion
    • Distribution countries
    • Comments
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.)