One post tagged with "batch-processing"

In pharmaceutical manufacturing, a deviation isn't just a quality issue — it's a regulatory event. Every out-of-specification reading triggers an investigation, potentially a CAPA (Corrective and Preventive Action), and possibly a batch disposition decision that can write off millions of dollars in product. FDA warning letters, consent decrees, and import alerts have shut down facilities for years over preventable equipment and process failures. Industrial IoT provides the continuous monitoring that traditional periodic checks miss — catching deviations in minutes instead of hours, and enabling predictive equipment management that keeps validated systems running within their qualified parameters.