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      • R-023-001_001 Change control
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      • R-023-001_003 Change control
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  • GP-023 Change control management
  • R-023-001_001 Change control

R-023-001_001 Change control

Change description​

  • Change name: Change in Person Responsible for Regulatory Compliance (PRRC)
  • Change description: in October 2023, one of the PRRC of Legit.Health left the company. As a consequence, a new person was hired to cover the vacancy starting from February 1, 2024. The previous PRRC has been hired as external consultant to perform part of the activities of the PRRC.
  • Source of change: company's organization

Impact analysis​

  • Regulatory impact: does the change require notification to Regulatory Authorities (Notified Body/Competent Authority)?
    • Yes: The change in PRRC is considered a significant change, therefore it shall be notified to our Notified Body (BSI).
    • No
  • Risk analysys impact: the change in PRRC does not add any new risks or modify existing ones due to the evidence of experience of the new person in charge. Plus, in the company, the PRRC function is also covered by another person (JD-005) and the previous PRRC is still partially covering her responsibilities.
  • Quality documentation impact: organizational chart, Annex 4 (Substitution table) of Quality Manual

Approval​

Change approved

Plan​

  • Organizational chart update (HR department)
  • Annex 4 (Substitution table) of Quality Manual (Quality Manager)
  • Modify registry in EUDAMED (Quality Manager)
  • Designation of new PRRC (CEO)
  • Notification of change to BSI (Quality Manager)

Implementation​

Implementation date: Insert the date in which all the activities defined in the change plan section are successfully implemented

Record signature meaning​

  • Author: JD-004 Giulia Foglia
  • Review: JD-005 Alfonso Medela
  • Approval: JD-001 & JD-003 Andy Aguilar
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GP-023 Change control management
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R-023-001_002 Change control
  • Change description
  • Impact analysis
  • Approval
  • Plan
  • Implementation
  • 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.)