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MES Enables Predictability

It takes weeks or months to release a vaccine batch to the FDA for review. This big pharma customer previously had a complex batch record consisting of over 1,200 pages and taking over 30 days to complete. Every page had multiple opportunities for human error including incorrect entries, miscalculations, and executing steps out of order. Administrative controls as well as rigorous and time-consuming batch record reviews were required at the end of production to ensure product quality.

By implementing an electronic batch record in MES, this pharma manufacturer practically eliminated opportunities for error—enabling more predictable batch release cycle times, and ultimately reducing finished goods inventory.