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QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
  • Records
    • GP-001 Documents and records control
    • GP-002 Quality planning
    • GP-003 Audits
    • GP-004 Vigilance system
    • GP-005 HR and training
    • GP-007 Post-market surveillance
    • GP-009 Sales
      • R-009-001 Implementation plans
        • R-009-001 Iderma 20230301
        • R-009-001 Sermas 20230301
        • R-009-001 Galderma 20230727
        • R-009-001 Boehringer Ingelheim 20240207
        • R-009-001 Ribera Salud 20240708
        • R-009-001 Hospital del Mar 20240709
    • GP-010 Suppliers
    • GP-012 Design, Redesign and Development
    • GP-018 Infrastructure and facilities
    • GP-019 Software validation
    • GP-023 Change control management
    • GP-050 Data Protection
    • GP-051 Security violations
    • GP-052 Data Privacy Impact Assessment (DPIA)
  • TF_Legit.Health_Plus
  • Licenses and accreditations
  • External documentation
  • Procedures
  • Records
  • Records
  • GP-009 Sales
  • R-009-001 Implementation plans
  • R-009-001 Boehringer Ingelheim 20240207

R-009-001 Boehringer Ingelheim 20240207

  • Governed by GP-009 Sales
  • Comes from template T-009-001 Implementation plan

Contract sign date​

Contract sign date: 2024 03 07 (YYYY MM DD)

Project leads​

TeamFull nameLeader of
Legit.HealthSara RecaldeProject Manager
Legit.HealthAlfonso MedelaMachine Learning Engineer
Legit.HealthTaig Mac CarthyProject Director
Boehringer IngelheimJennifer CordovaProject Director
Boehringer IngelheimGurpreet ChowdhryProject lead
Boehringer IngelheimPhilipp SchwarzTechnical lead
Boehringer IngelheimChristian ThomaEvidence Medical Advisor

Goals​

Goals for the 1st year​

The customer implements Legit.Health's medical device to achieve the following goal(s):

Goal
Statistically reliable AI can be derived from the available images.
An AI that can identify GPP with 76% top3 accuracy and 80% top5 accuracy can be developed.
The AI can differentiate between GPP and similar indications.
AI can assess GPPGA (Generalized Pustular Psoriasis Physician Global Assessment) with 70% agreement (Cohen's Kappa (κ)).

Implementation timeline​

To achieve the goals, the parties agree on the following timeline.

1st year timeline​

To achieve the goals, the parties agree on the following timeline.

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, JD-004
  • Approver: JD-001
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R-009-001 Galderma 20230727
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  • Contract sign date
  • Project leads
  • Goals
    • Goals for the 1st year
  • Implementation timeline
  • 1st year timeline
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.)