The requirements in a regulated environment of the pharmaceutical industry are not only high for the companies within this business sector – but their suppliers must also meet these requirements. The close network of international and national rules and regulations for the pharma industry becomes ever tighter, and is made even stronger by the company's own in-house regulations in order to continuously meet the high quality standards. Even we, as a supplier, are bound by and operate within these networks, in order to ensure meeting GxP compliance standards. We aim to support your process optimization and achievement of quality standards so that your network may stay seamless and secure.

To develop computer-assisted systems, we must consider company-internal, national and international FDA guidelines -> 21 CFR 210, AMWHV and AMG – we do this during the risk-based analysis as well as during software modeling. In addition, following the GAMP 5 guidelines, EU-GMP guidelines (app. 15), PIC/S and other guidelines for instance, is a prerequisite for the required validation and implementation of such applications in a company operating in the pharmaceutical sector. In addition to our know-how, we also offer you strategies, processes and documents that are individually tailored to meet the regulatory requirements that apply to you.