The latest version of the Lytzen control system Lytcon 2 is designed for facilities which have to be compliant with FDA 21 CFR part 11. The system is based on brands known world-wide (Siemens/Allen-Bradley & Eurotherm). The system provides a password protection and an audit trail as required by part 11. The system can easily be connected to a SCADA-system and Lytzen provides the software for handling the data on PC.