Skip to main content
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-009 Sales
    • GP-010 Purchases and suppliers evaluation
    • GP-011 Provision of service
    • GP-012 Design, redesign and development
      • Templates
        • T-012-019 SOUP
        • 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-012-043 Traceability Matrix
        • T-012-044 SOUP Request and Approval Form
        • obsolete
    • 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-027 Corporate Governance
    • GP-028 AI Development
    • GP-029 Software Delivery and Commissioning
    • GP-030 Cyber Security Management
    • 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
  • Legit.Health Utilities
  • Licenses and accreditations
  • Applicable Standards and Regulations
  • Pricing
  • 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

Final Risk Assessment​

Per GP-013 Risk Management, verify that the final risk assessment is complete before proceeding with commissioning.

ObjectRecords & CommentsSatisfyingReserves
All risks have been identified and assessed in T-013-002 Risk Management Record
All risk control measures have been implemented
"Verification of Effectiveness" column in T-013-002 is completed for all risk control measures
All residual risks are within acceptable limits
No unacceptable new risks were introduced by risk control measures
If unacceptable risks exist, they are outweighed by benefits as documented in Clinical Evaluation Report
T-013-003 Risk Management Report is finalized
Software Safety Classification (R-TF-012-041) is finalized

Outputs review​

ObjectRecords & CommentsSatisfyingReserves see
Version Delivery Description
Clinical Evaluation plan
Clinical Evaluation report
Clinical Investigation report
Usability Summative Evaluation Report
AI/ML Evaluation Report
Cybersecurity Report
PMS Plan (R-TF-007-001)
PMCF Plan (R-TF-007-002)
Labeling and IFU verified per T-012-037
DMF is updated

Regulatory requirement review​

KeySummaryDescriptionSatisfyingReserves

Reserves​

N°Documents / Purpose / Actions to implementOwnerTargeted Date

Commissioning activities​

Per GP-029 Software Delivery And Commissioning, commissioning activities must be completed and documented before design transfer.

ObjectRecords & CommentsSatisfyingReserves
T-029-001 Deployment & Configuration Commissioning is completed
T-029-002 Functional & Interface Commissioning is completed
T-029-003 Clinical Workflow & Operational Readiness Commissioning is completed
Software version behaves as expected on the production environment

Post-Commissioning Risk Review​

Per GP-013 Risk Management and ISO 14971:2019, after commissioning activities are completed, confirm that no new risks were identified.

ObjectRecords & CommentsSatisfyingReserves
No new risks were identified during deployment and configuration commissioning (T-029-001)
No new risks were identified during functional and interface commissioning (T-029-002)
No new risks were identified during clinical workflow commissioning (T-029-003)
No existing risk control measures were found to be ineffective in the production environment
T-013-002 Risk Management Record is updated if any new risks were identified
Overall residual risk assessment and risk-benefit analysis remain valid
Risk Management File closure is confirmed

Design Transfer​

ObjectRecords & CommentsSatisfyingReserves
T-012-039 Validated Version Transfer is completed and approved
Design transfer documentation reviewed - artefacts suitable for deployment in target servers
Customer success department notified and prepared for necessary actions

Conclusion​

Phase 5 Closure Confirmation​

Upon approval of this checklist (T-012-026) and T-012-039 Validated Version Transfer, Phase 5 is complete and the Technical File for this version is formally closed.

Closure criteriaConfirmed
All validation activities have been completed satisfactorily
All regulatory documentation is complete and consistent
All procedural reports (Clinical, Risk Management, Usability, Cybersecurity, AI/ML) are finalized
Risk Management File has been closed with no outstanding risks
Design History File (DHF) contains all required records for this version
Version is ready for regulatory submission and market release

Distribution countries​

Comments​

  • Does the IFU and labelling contain all expected information?: 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
  • Final Risk Assessment
  • Outputs review
  • Regulatory requirement review
  • Reserves
  • Commissioning activities
  • Post-Commissioning Risk Review
  • Design Transfer
  • Conclusion
    • Phase 5 Closure Confirmation
    • 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.)