As a sensitive industry with a direct impact on human health, the pharmaceutical industry is one of the most strictly regulated industries worldwide. SAP Business One for the Pharma industry is a robust, scalable, flexible, and high-performing ERP solution.
The digital batch record in the SAP system makes the complete production and origin process of individual components transparent and shows exactly who, what, when and which process parameter is available in the access log.
It covers the Good Manufacturing Practice (GMP) or FDA or 21CFR requirements for a processing log for each batch produced and contains all quality-relevant planned and actual data for the batch production. The structure and contents of the batch record comply with international standards that are defined by GMP guidelines and managed in SAP Pharmaceutical Solution.