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).
If, for example, the enterprise software uses a central backup system for backing up and restoring data, the IT department can offer the qualified basic services (backup procedures, cycles, tape rotations) as a standard service. These are/have been sufficiently tested in advance as part of the qualification measures, which has the advantage that guaranteed reaction times are based on factual tests and are therefore of a realistic nature. Deviations from defined basic services are to be requested by the respective client (internal or external) accordingly.
- We offer our customers professional consulting, as well as solutions for appropriate and compliant documentation of the IT infrastructure (components).
- We create and optimize strategies and advisory documents and ensure that they can be understood and implemented within the departments.