In GxP-regulated environments, companies face a number of recurring challenges that affect both technical and organizational aspects. Issues such as data security and redundancy are particularly critical, as all information must be traceable, protected, and available at all times. At the same time, the integration of a wide variety of systems—from sensor technology and LIMS/MES to cloud and on-premise structures—is becoming increasingly complex.
The scalability of existing solutions also plays an important role, as production and quality processes are constantly growing and need to be adapted flexibly without compromising compliance. Another crucial factor is the reliability of sensors and ensuring regular, documented calibrations to guarantee valid measurement data.