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IT infrastructure audit

Hospital pharmacies


  • IT audit of the enterprise resource planning (ERP) system, Apovision, that serves as the infrastructure system for all public hospital pharmacies in Denmark in each of the 5 Regions.
  • Apovision is based on Navision, and a major upgrade lead by the IT supplier, Netcompany, had to be audited.
  • Netcompany did not have their own Quality Management System (QMS), so the project headed by Region Nordjylland IT had to establish the QMS.
  • Audit of both ERP and QMS.

Solution - Proces

  • Initial alignment meeting between the head of the Quality Team and all Quality Team representatives from each of the 5 Regions, all giving input to the IT audit plan, incl. observed potential compliance issues

  • It was agreed, that the IT audit should address that,

    • Overall, the project is in compliance with quality procedures according to EU GMP Annex 11, including GDP and GMP.

    • Specifically, Netcompany is in compliance with the requirements outlined in the procedures.


  • Onsite IT Audit of QMS, relevant systems and stakeholders.
  • IT audit report with non-compliance issues and recommendation.
  • Workshop with the Quality Team representatives, where the audit report was carefully presented, including discussion and planning of input for remediation.
#Pharma #Audit #ERP #QMS #Infrastructure #Hospital #Navision #Annex11

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Henrik Johanning

CEO & seniorkonsulent
IT & Automation / GAMP, Regulatory Affairs, Project Management, Management Consulting, GMP, Træning