Dong-A ST

Dong-A ST, a subsidiary of Korea's oldest pharmaceutical company, faced mounting pressure to expand production capacity while simultaneously qualifying for international markets. Building a new greenfield facility in Songdo required compliance with cGMP (current Good Manufacturing Practice) regulations across multiple regulatory jurisdictions — a notoriously complex challenge in pharmaceuticals, where data integrity failures can halt market approvals or trigger costly recalls. Without a unified digital infrastructure from day one, the facility risked siloed paper-based batch records, inconsistent data across systems, and an extended validation timeline that would delay market entry and undermine the business case for the new plant.

Dong-A ST partnered with Rockwell Automation to deploy a fully integrated digital manufacturing stack at the Songdo facility. At its core, FactoryTalk PharmaSuite MES provided pharmaceutical-specific manufacturing execution with built-in cGMP compliance workflows. FactoryTalk ProductionCentre handled production operations management, while the FactoryTalk Enterprise Integration Hub (EIHub) unified data flows across systems. The ThingWorx IIoT platform connected shop-floor equipment via IoT sensors, enabling real-time process monitoring and data capture at the equipment level. FactoryTalk Analytics DataView surfaced operational intelligence, and a SCADA/EMS system managed environmental and energy monitoring. Because the facility was built from greenfield, the entire stack was designed-in rather than retrofitted, enabling seamless system integration and a cleaner validation path.

The integrated MES and IIoT stack enabled Dong-A ST to achieve validated manufacturing operations at the Songdo facility, satisfying the data integrity and audit trail requirements demanded by global regulatory authorities. Key outcomes include:

• Regulatory compliance achieved: cGMP validation of the manufacturing environment, quality controls, and data classification was completed across all applicable international frameworks
• Streamlined reporting: regulatory documentation and compliance reporting were significantly accelerated through automated data capture and system-generated records
• Global market access: successful GMP certification enabled Dong-A ST to pursue export markets previously out of reach
• Paperless operations: workers can complete all batch record work from a single tablet PC, eliminating paper-based processes across the production floor

• MES platforms with purpose-built pharmaceutical compliance modules (such as PharmaSuite) substantially reduce the manual effort required for batch record management and regulatory reporting
• Greenfield deployments offer a material advantage over retrofits: designing digital infrastructure into new facilities from the start produces cleaner system integration, faster validation timelines, and lower total cost
• IIoT connectivity at the equipment layer is a prerequisite for real-time data integrity — sensors feeding directly into MES eliminate transcription errors that routinely cause cGMP deviations
• Unified data integration hubs are essential when a single plant must satisfy multiple international regulatory frameworks simultaneously