“We made the right choice with BatchMaster, and we are very happy and satisfied with it.”

Mr. Minsung Kim,

Head, ERP System,

Dong-A Pharmaceutical

Customer

Dong-A Socio Holdings, Dong-A ST, Dong-A Pharmaceutical and DM Bio

Location

Seoul, South Korea

Industry

Pharmaceuticals

Systems Replaced

In-house System

Solution

BatchMaster with SAP Business One

Dong-A Socio Group Streamlines Manufacturing and Compliance with BatchMaster

Dong-A Socio Holdings is one of South Korea’s leading pharmaceutical organizations, with businesses spanning ethical drugs, OTC products, biopharmaceuticals, APIs, medical equipment, and healthcare innovation. Through subsidiaries including Dong-A ST, Dong-A Pharmaceutical, and DM Bio, the company serves customers across South Korea and approximately 40 countries worldwide.

As the organization expanded and restructured into multiple specialized business units, Dong-A recognized the need for a modern ERP platform to unify operations, support compliance requirements, and improve visibility across all divisions.

To support this transformation, Dong-A selected BatchMaster Manufacturing for SAP Business One as its integrated process manufacturing ERP solution.

Challenges

Before implementing BatchMaster, Dong-A relied on a legacy in-house ERP system that struggled to keep pace with the growing complexity of its operations and regulatory requirements.

A majority of the company’s compliance-related struggles stemmed from the fact that the legacy system was not capable of managing the compliance needs of all three businesses. This resulted in insufficient control over the compliance activities and limited or no real-time compliance reporting, thus creating the need for a new system laden with proficient compliance management functionality.

As the Dong-A Group wanted to use the new ERP system for cGMP-critical operations, it also wanted the prospective software to have third-party testing and subsequent validation done. This was a pre-requisite for the company, as any such validation would have testified that the product is in line with FDA and global regulatory guidelines and meets all the FDA and cGMP standards. Another requirement of the software was third party manufacturing capability.

1. Managing Multiple Businesses on Separate Processes

Following a corporate restructuring, Dong-A needed a single ERP solution to support the unique manufacturing, financial, and operational requirements of multiple business divisions.

2. Meeting Strict Compliance Requirements

The company faced increasing pressure to comply with FDA regulations, GMP guidelines, and FDA 21 CFR Part 11 requirements while maintaining detailed manufacturing and quality records.

3. Limited Quality and Traceability Capabilities

Dong-A required stronger in-process quality control, lot traceability, CAPA management, and batch manufacturing record capabilities to improve compliance and operational oversight.

4. Outdated and Inflexible Legacy Software

The existing system lacked the scalability, flexibility, and industry-specific functionality needed to support evolving pharmaceutical manufacturing processes.

Solution

After evaluating several ERP providers, Dong-A selected BatchMaster Manufacturing for SAP Business One for its pharmaceutical-industry functionality, compliance capabilities, scalability, and seamless integration with SAP Business One.

“Our goal was to implement an ERP system that would be robust yet flexible,” explained Mr. Minsung Kim, Head of ERP System at Dong-A Pharmaceutical.

BatchMaster provided the company with integrated capabilities for:

Formula and batch management
Quality control and compliance tracking
FDA 21 CFR Part 11 compliance
GMP support and batch manufacturing records
Planning and scheduling
Inventory and lot traceability
CAPA and non-conformance management

The implementation also allowed Dong-A to standardize processes across multiple businesses while supporting each division’s unique operational requirements.

Key Results

Improved Compliance and GMP Management

BatchMaster Manufacturing helped Dong-A simplify compliance with GMP and FDA regulations by improving documentation, quality management, and traceability processes.

The company can now create and maintain Batch Manufacturing Records (BMRs) and Manufacturing Batch Records (MBRs) electronically, thereby replacing many previously manual, paper-based processes.

Integrated in-process quality control functionality also allows Dong-A to monitor production quality throughout manufacturing stages.

Enhanced Lot Traceability and Recall Readiness

With BatchMaster’s forward and backward traceability capabilities, Dong-A gained stronger control over raw materials and finished goods throughout production and distribution.

The system provides detailed lot tracking and improved visibility for audits, inspections, and compliance reporting.

Stronger Quality Management and CAPA Processes

BatchMaster enabled Dong-A to centralize quality testing, quarantine management, release procedures, rejection tracking, non-conformance handling, and CAPA processes within a single integrated platform.

This improved consistency, compliance oversight, and operational control across all divisions.

Unified Operations Across Multiple Business Units

One of the company’s biggest achievements was successfully integrating multiple subsidiaries and business processes into a single ERP environment.

BatchMaster’s flexibility allowed Dong-A to standardize critical operations while still supporting the unique requirements of each division.

Smooth Transition from Legacy Systems

Despite the complexity of replacing an aging ERP system across multiple businesses, the implementation process was completed successfully with strong support from the BatchMaster consulting team.

Pilot exercises and user training helped employees transition smoothly to the new system while improving collaboration across departments.

Looking Ahead

With BatchMaster Manufacturing for SAP Business One in place, Dong-A Socio Group now has a scalable, compliant, and fully integrated ERP platform to support continued growth and innovation across its pharmaceutical businesses.

The company strengthened its ability to manage compliance, quality, traceability, manufacturing, and planning processes while creating a unified operational foundation for the future.

About BatchMaster Software

BatchMaster Software is a leading provider of ERP solutions that help emerging and growing formula-based manufacturers streamline their operations and scale production while reducing costs and complying with changing customer demands and ever more stringent regulatory mandates. The company delivers industry-specific solutions for Food, Beverage, Nutraceuticals, Pharmaceuticals, Cosmetics, Chemicals, and other process industries. BatchMaster ERP is seamlessly embedded within SAP Business One, providing a comprehensive process manufacturing solution that is available on-premise and in the cloud. BatchMaster Software has served the process manufacturing market for over 30 years and supports thousands of customers worldwide.