Our company has been present in the field of pharmaceuticals since its foundation, whether it is the modernization of control equipment of the manufacturing industry or the development of complete production support systems. During the implementation of our pharmaceutical projects, we pay close attention to the requirements of GAMP and the FDA to ensure full validation and qualification.
-Modernization of existing systems
–Industry 4.0 system integration, data collection
–Production Support Systems (MES)
-Measuring and material recording systems
-Electronic Documentation (EBR / MBR)
-SAP interface modules, ERP integration
-Applying GAMP 5 exercise
-21 CFR Part 11 Compliance
-Follow EudraLex Vol 4 Annex 11 guidelines
We have already proven: Chinoin, Egis, GlaxoSmithKline, Human BioPlasma, Linde Gas, PharmaSwiss, Procter & Gamble, Gedeon Richter, Sanofi-Aventis, Teva, Xellia
