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.

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.