Annual focus

The inspection focus for 2026

Focus on computerised systems at GDP inspections
In the year ahead, the Danish Medicines Agency will have increased focus on computerised systems when inspecting GDP companies. At our inspections, we will therefore, on a spot-check basis, review compliance with the guidelines’ requirements in relation to computerised systems.
When we give notice of a GDP inspection, we will as always ask for a list of computerised systems used for GDP activities/processes. This could be computerised systems such as ERP, document management and temperature monitoring systems. 

The background and requirements are described in section 3.3.1 of the GDP Guidelines.