How is AVEVA Batch Management modernizing pharmaceutical manufacturing?
At Baxter SA, AVEVA Batch Management orchestrates the execution of manufacturing recipes with a rigor that meets FDA and European requirements. Combined with System Platform and InTouch HMI, it ensures the precise sequencing of operations, the traceability of every batch and the automatic recording of critical parameters. This digitalization of batch processes is a standard in the life sciences, where process integrity determines drug quality.
How did AVEVA help double productivity at a pharmaceutical plant?
The doubling of productivity at Baxter SA results from the combination of System Platform, Batch Management, InTouch HMI and Historian, which eliminate manual handling, speed up batch release and streamline coordination between teams. A library of generic objects makes it possible to quickly deploy new recipes without rewriting the application. This industrialization of monitoring transforms production capacity without major capacity investment.
How can compliance with both FDA and European standards be ensured?
AVEVA System Platform and Historian provide the traceability and electronic signature infrastructure required by the FDA (21 CFR Part 11) and equivalent European standards. At Baxter SA, integrator BiiON configured the solution to meet transatlantic requirements in a single system. This built-in compliance avoids duplicated controls and turns a regulatory constraint into an operational advantage in global life sciences markets.
What role does a library of generic objects play in batch management?
The AVEVA System Platform library of generic objects allows Baxter SA to model each piece of equipment and each process step once, then reuse it across the entire line. This standardization speeds up the deployment of new recipes, reduces configuration errors and simplifies application maintenance. It is an industrial engineering approach that turns monitoring into a reusable, lasting and scalable asset.
How does AVEVA InTouch HMI strengthen traceability on a new pharmaceutical line?
AVEVA InTouch HMI gives Baxter SA operators a standardized graphical interface that captures every human action, setpoint and alarm in a complete audit trail. This operator traceability, combined with automatic data recording through Historian, ensures the integrity of the batch record required by the FDA. In pharma, this digital continuity from raw data to release approval is essential for regulatory robustness.
