Case Study: Dong-A Pharmaceutical achieves streamlined manufacturing operations and regulatory compliance with BatchMaster Software

BatchMaster helps Dong-A Socio Group streamline manufacturing operations & manage compliance regulations

Dong-A Pharmaceutical, part of Dong-A Socio Holdings, is a leading South Korean pharmaceuticals manufacturer that struggled after a corporate split when its legacy in‑house software could not support multi‑divisional operations, real‑time compliance reporting, or stringent regulatory needs (FDA 21 CFR Part 11, GMP). To unify manufacturing, finance and quality across its new entities and meet requirements for third‑party validation, in‑process QC, NC/CAPA and advanced scheduling, Dong-A selected BatchMaster Software’s BatchMaster Manufacturing for SAP Business One.

BatchMaster Software implemented BatchMaster Manufacturing for SAP Business One as a built‑in process‑manufacturing ERP add‑on, enabling BMR/MBR creation, forward/backward traceability, in‑process and finished‑goods QC, NC/CAPA, inventory control and advanced planning/scheduling, while meeting FDA 21 CFR Part 11 requirements. The solution streamlined and automated critical processes, brought all three businesses onto a single platform, simplified GMP compliance and quality control, and gave Dong-A Pharmaceutical confidence in regulatory reporting and production traceability—so much so that Dong-A agreed to be a BatchMaster reference customer.

Dong-A Pharmaceutical

Minsung Kim

Head, ERP System