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Pharmaceutical Statiscal Process and 21 CFR Part 11 Compliant Emulation

The Emulogix emulator of the manufacturing system created production data and passed the data to the conveyor and data gateway. At the same time, the emulator informed the conveyor emulator of the induction of consumables on a conveyor system.

The data gateway system tracked the product through a conveying and labeling system using the conveyor emulator.

At the appropriate point, the data gateway passed data to the statistical process control (SPC) system.

The system developer used the overhead view to visually monitor the progress of the consumables on the conveyor system, and confirm the acquisition and distribution of data at the appropriate points. The emulator generated logs to document the data exchange.