The audit trail has long been established in FDA- and GMP-regulated pharmaceutical and biotech facilities. Process control systems, process database systems and higher-level automation systems log changes, user actions and system events.
However, a significant gap often remains at the field level. The importance of the process analytics measuring point is often underestimated. Calibrations, adjustments, sensor replacements, parameter settings and user access are not performed in the control system, but rather at the transmitter.
These events are critical for process control and batch evaluation. They show when a measuring point was changed, who made the change and the context in which an event occurred. If this information is stored locally, for example on cards or in device logs, it results in manual retrieval steps and increased data-integrity risks.
Pharma 4.0 aims to provide interconnected, more timely and systematically usable process and product data.
The Protos II 4400(X) from Knick is an example of this approach. By providing audit trail records directly via fieldbus, the transmitter enables automated integration of field-level events into higher-level systems and supports a continuous data flow from the measuring point to central review and archiving processes.
