GxP Conformity - Your Safety Net
The requirements in the regulated environment of the pharmaceutical industry are not only high for the companies within this sector - their suppliers must also meet these requirements. The tight network of international and national rules and regulations is made even stronger by the company-specific regulations that are set by a pharmaceutical company. Even as suppliers, we too operate within this network so that we can ensure GxP conformity. We want to support you by providing tools to optimize your processes and to comply with your quality standards, so that your network remains secure.

To develop computer-assisted systems, we must consider company-internal, national and international guidelines for the FDA -> 21 CFR 210, AMWHV and AMG during the risk-based analysis as well as during the modelling. In addition, following, for example,
the GAMP 5 guidelines, EU-GMP guidelines (app. 15), PIC/S and other guidelines is a prerequisite for the required validation and implementation of such applications in a company that is active in the pharmaceutical environment. 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.

Consultation and Support for System Validation
In the pharmaceutical sector, computerized systems are subject to strict requirements. For quality and security reasons, each system that is used must be validated and must then be revalidated at regular intervals and when any changes are implemented. The development of relevant tools underpins not only our expertise in this area, but it also provides you with support when you create validation documentation.