
In regulated environments within the Life Science industry, GxP compliance is of central importance. This presentation highlights how modern technologies address the requirements for monitoring and validation. Siemens' solutions will be introduced, including wireless monitoring and temperature mapping, which enable the surveillance of critical parameters in cleanrooms and storage areas. A key focus is the Siemens Connect Box, an IoT solution for the wireless acquisition and local storage of calibrated sensor data for, for example, temperature and humidity. The optional cloud connection of these systems supports transparent, secure, and traceable data access, as well as the efficient creation of GxP-relevant reports. Another emphasis is on the digitalization of validation documentation: The presentation outlines the transition from manual, Excel/Word-based processes to web-based, integrated systems. This development helps shorten planning times, minimize risks, and ensure data integrity throughout the entire lifecycle. Siemens offers services from planning and implementation to qualification and maintenance, to support compliance with regulatory requirements such as GMP/GAMP5.
