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  • Welcome to your QMS
  • Quality Manual
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  • Records
    • GP-001 Documents and records control
    • GP-002 Quality planning
      • Deprecated
      • R-002-001 Quality objectives list_2024_001
      • R-002-001 Quality objectives list_2025
      • R-002-002 Quality objectives_2024_001
      • R-002-002 Quality objectives_2024_002
      • R-002-002 Quality objectives_2024_003
      • R-002-002 Quality objectives_2024_004
      • R-002-002 Quality objectives_2024_005
      • R-002-002 Quality objectives_2025_001
      • R-002-002 Quality objectives_2025_002
      • R-002-002 Quality objectives_2025_003
      • R-002-002 Quality objectives_2025_004
      • R-002-002 Quality objectives_2025_005
      • R-002-003 Quality indicators_2024
      • R-002-004 Annual management review report
      • R-002-005 Quality Calendar_2025
      • R-002-006 SWOT and CAME analysis
      • R-002-007
      • R-002-008 Quality and regulatory roadmap
      • R-002-009 Regulatory requirements review report
    • GP-003 Audits
    • GP-004 Vigilance system
    • GP-005 HR and training
    • GP-007 Post-market surveillance
    • GP-009 Sales
    • 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)
    • GP-200 Remote Data Acquisition in Clinical Investigations
  • TF_Legit.Health_Plus
  • Licenses and accreditations
  • External documentation
  • Records
  • GP-002 Quality planning
  • R-002-005 Quality Calendar_2025

R-002-005 Quality Calendar_2025

Yearly calendar​

Notes​

  • CV review: every employee shall review and update the CV with any new relevant information (e.g training performed during the year, certifications acquired) once a year during the period established in the calendar above
  • NC/CAPA review: JD-004 shall review every quarter the status of the non-conformities and CAPA, update their status with latest information and monitor the timing of opening non-conformities and CAPA from first detection of the issue to ensure their are registered without undue delay
  • Regulatory requirements review: JD-004 shall review the applicable regulatory requirements on a semi-annual basis to ensure compliance of the QMS and of the device. The results of this activity are documented in T-002-009
  • Regulatory roadmap review: JD-004 shall review the regulatory roadmap and update it accordingly (if necessary) on a quarterly basis. The results of this activity are documented in T-002-008
  • Internal documents review: JD-004 shall review and update, if necessary, the list of internal documents to ensure that the latest version and approval date are available in the list. The results of this activity are documented in T-001-001 and the activity is performed every 2 months
  • Literature review, Similar devices data review, Research on cybersecurity and state of the art, Research on SOUP/software tools security vulnerabilities: these activities are part of the post-market surveillance plan, documented in the R-TF-007-001. More details on these tasks can be found directly in the R-TF-007-001 Post-Market Surveillance (PMS) Plan of the device
  • Other post-market activities: details on the specific activities planned for the post-market phase can be found in the R-TF-007-001 Post-Market Surveillance (PMS) Plan of the device
  • Novartis Brazil regulatory confirmation: this activity is coming from the contract with the client Novartis Brazil; each year (in the first quarter) we shall provide Novartis Brazil with the confirmation that we comply with the applicable regulatory requirements set out in the Brazilian regulation for medical device. This confirmation will be documented in a template that Novartis Brazil will provide us. This confirmation will probably not be required for 2025 because we are waiting for ANVISA approval

Monthly calendar​

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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: JD-004
  • Reviewer: JD-001
  • Approver: JD-001
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R-002-004 Annual management review report
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R-002-006 SWOT and CAME analysis
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