Our firm has been offering consulting services in the life sciences and working in the field of IT compliance since 1996. Our first clients were SAP customers from the pharmaceuticals industry, who needed to validate their systems due to stringent regulatory requirements. Validation accordingly became one of our key consulting topics, and so we developed a process-oriented and risk-based DHC validation method. We orient ourselves naturally here on the lifecycle model (V-Model) according to the latest version of GAMP, the relevant ISO standards (e.g. ISO 13485) and the regulatory requirements of the FDA (e.g. 21 CFR Part 11) and European regulators (e.g. EU GMP Annex 11).
We offer you a full and comprehensive set of services focused on IT compliance. These services also include the standardisation and harmonisation of validation and qualification measures, so as to meet the widest possible range of regulatory requirements. These services aim to simplify your IT QM, thereby saving you both time and money.
Our specialised know-how related to validation and IT compliance is further complemented by our industry experience as well as our expertise in process and project management.