IT infrastructures
We support you holistically or in sub-projects with the risk-based implementation of formal requirements for your IT system landscape. You benefit from our wealth of experience in implementing IT infrastructures that conform to regulatory requirements.
Exceprt from Annex 11 of the EU-GMP Guideline: „ … IT infrastructure should be qualified.”
IT infrastructure has often grown over many years and are therefore hard to oversee. This leads to high operating and maintenance costs and is associated with a significant operational risk. By skillfully integrating processes, applications and IT infrastructure, companies can maintain control over their organically grown infrastructure in the long-term. This requires integrative approaches.
An IT infrastructure is much more than the sum of its components. What is often missing is a documented, conceptual superstructure as an interface to company logistical processes.
An essential advantage of a qualified IT infrastructure is the avoidance of redundancies and an increase in standardization. Configuration objects shared by several application systems only need to be qualified once in their basic elements (process, hardware, software).
