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-012-039 Validated Version Transfer

T-012-039 Validated Version Transfer

Actors​

NameTitleMeaningApproved Date & Time

Change history​

RevisionSummaryDate

Project information​

  • Project title:
  • Version number:
  • Release date:

Pre-requisites verification​

Before completing this document, verify that all required Phase 5 activities have been completed:

Pre-requisiteReference DocumentCompleted
T-012-025 Software Verification Phase 4 Checklist approvedT-012-025
T-012-038 Verified Version Release completedT-012-038
Clinical Evaluation Report finalizedR-TF-015-003
Usability Summative Evaluation Report finalizedR-TF-025-007
Risk Management Report finalizedR-TF-013-003
Final Risk Assessment completed (Verification of Effectiveness column)R-TF-013-002
Cybersecurity Assessment Report finalizedR-TF-030-003
AI/ML Release completed (if applicable)R-TF-028-006
PMS Plan finalizedR-TF-007-001
PMCF Plan finalizedR-TF-007-002
Commissioning records completedT-029-001, T-029-002, T-029-003
Post-commissioning risk review completedT-012-026
T-012-026 Product Validation Phase 5 Checklist approvedT-012-026

Artefacts transferred to production​

Instructions

List all artefacts that are transferred to the production environment as part of this release. Include software components, configuration files, documentation, and any other deliverables.

Software components​

ArtefactVersion/TagRepository/LocationVerified

Documentation​

DocumentVersionLocationVerified
Instructions for Use (IFU)
Label
Technical Documentation
Design History File (DHF)

Configuration​

Configuration ItemValue/SettingEnvironmentVerified

Regulatory readiness​

Regulatory requirementStatusReference
GSPR Checklist completed and demonstrates conformityR-TF-008-001
EU Declaration of Conformity preparedR-TF-001-007
UDI assigned and registered
Notified Body submission ready (if applicable)
FDA submission ready (if applicable)

Release authorization​

Instructions

This section formally authorizes the release of the validated version to the market. Complete this section only after all pre-requisites have been verified and all artefacts are ready for production.

Version information​

  • Version number:
  • Version tag in repository:
  • Changelog reference:

Authorization statement​

The undersigned confirm that:

  1. All Phase 5 validation activities have been completed satisfactorily
  2. All regulatory documentation is complete and consistent
  3. All procedural reports (Clinical, Risk Management, Usability, Cybersecurity, AI/ML) are finalized
  4. The Risk Management File has been closed with no outstanding unacceptable risks
  5. The Design History File (DHF) contains all required records for this version
  6. The version is ready for regulatory submission and market release

Approval​

RoleNameSignatureDate
JD-001 (Top Management)
JD-003 (Quality Manager)
JD-004 (Regulatory Affairs)
JD-007 (Technical Manager)

Post-release actions​

ActionResponsibleTarget DateStatus
Notify regulatory authorities (if required)
Update Device Master File (DMF)
Communicate release to Customer Success
Archive Technical File version
Initiate Post-Market Surveillance activities
Previous
T-012-038 Verified Version Release
Next
T-012-040 Documentation level FDA
  • Actors
  • Change history
  • Project information
  • Pre-requisites verification
  • Artefacts transferred to production
    • Software components
    • Documentation
    • Configuration
  • Regulatory readiness
  • Release authorization
    • Version information
    • Authorization statement
    • Approval
  • Post-release actions
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.)