Bioferlogics is an HMI/SCADA system that we have developed for our products in cooperation with our automation partners. Bioferlogics is an iFIX derivative (GE), like delta V and other visualization and display interfaces. Its basic implementation supports many of the requirements of 21 CFR Part 11. In spite of this support, it is essential to be open to the customer's specific wishes in particular cases. As a result, it is necessary to define, over several sessions, how, what and precisely where 21 CFR is to be implemented.

A basis is provided by the guidebook:

Gute Praxis und Erfüllung der Anforderungen an Elektronische Aufzeichnungen und Unterschriften.
(Good Practice and Satisfying the Requirements for Electronic Records and Signatures) (ISPE, PDA).

We also program on site, on the basis of an existing visualization scheme. This saves the plant operator additional license costs. A plant operator is also able to examine the visualization and display system as it is created. Continuity with the customer's process control system is, of course, ensured. The process is displayed abstractly by R&I.