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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
    • 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
      • Templates
        • T-023-001 Change control
    • GP-024 Cybersecurity
    • GP-025 Corporate Governance
    • GP-026 Product requirements for US market
    • GP-027 Product requirements for UK market
    • GP-028 Product requirements for the Brazilian market
    • 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
  • Records
  • TF_Legit.Health_Plus
  • Licenses and accreditations
  • External documentation
  • Procedures
  • GP-023 Change control management
  • Templates
  • T-023-001 Change control

T-023-001 Change control

Description​

  • Change name:
  • Change description:
  • Source of change: e.g. Nonconformity, CAPA, customer's feedback, regulatory requirement, etc.

Impact analysis​

  • Regulatory impact: Is the change classified as significant?
    • Yes (it requires notification to Regulatory Authorities). If Yes, explain why and which Regulatory Authorities will be notified
    • No (it does not require notification to Regulatory Authorities)
  • Risk analysys impact: evaluate whether the change introduce new risks, modify exisiting risks
  • Quality documentation impact: evaluate which QMS documents are impacted by the change, e.g. procedures, specific records

Approval​

Indicate if the change has been approved or discarded as a result of the impact anaylis investigation.

Plan​

List in this section the necessary activities to be taken in order to succesfully implement the change and the person (or department) responsible for their implementation

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
  • Review: JD-005
  • Approval: JD-001 or JD-003

Template signature meaning​

info

Delete this section when you create a new record from this template.

  • Author: JD-004
  • Review: JD-005
  • Approval: JD-001
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GP-023 Change control management
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GP-024 Cybersecurity
  • Description
  • Impact analysis
  • Approval
  • Plan
  • Implementation
  • Record signature meaning
  • Template 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.)