GxP-compliant processes
We help our customers with the validation and operation of ERP-systems and GxP-compliant processes.
The increasing number of data integrity violations is causing a paradigm shift in the GxP-regulated environment. In collaboration with our clients, we develop the optimal strategies for the prevention, detection and monitoring of data integrity violations.
GxP-compliant processes!?
ERP systems (e.g. SAP S4/HANA) are the most critical systems in a company due to their complexity and their use, above all, for the core processes such as production, release and distribution of drugs or medical devices. Distinctive issues usually arise in connection with the centralization or deliberate decentralization of processes and master data as well as very complex authorization concepts. The separation between business departments and IT or the ERP team often poses a great challenge, as this constitutes a break in the availability of knowledge and expectations. This makes coordinated, easily understandable processes all the more important.
According to GAMP© ERP systems usually fall into category 4 as configured software or, in the case of the in-house development portion, into category 5, and thus into the highest level with regard to validation requirements for a system. In addition, the ERP system is often used across multiple countries, companies, many process variants and distributed system landscapes.
