Accelerating Korean Biomanufacturing: How to Choose the Right Manufacturing Execution System (MES)

From Automation to Orchestration

Korea’s biopharmaceutical sector is advancing toward digital maturity. As the industry expands in biologics, vaccines, and advanced therapies, manufacturing operations are adopting higher levels of automation—from robotic fill-finish systems and isolators to SCADA platforms and real-time monitoring. Yet automation alone does not ensure control, compliance, or efficiency.

A Manufacturing Execution System (MES) is the orchestration layer that bridges enterprise IT and shop-floor operations. It delivers real-time control, ensures electronic batch traceability, and enforces regulatory compliance. For biopharma companies operating under GMP, adopting MES is a foundational step toward long-term digital transformation.

The South Korean MES in life sciences market generated a revenue of USD 74.7 million in 2023 and is expected to reach USD 198.3 million by 2030 and was declared as the fastest growing region market. In terms of revenue, South Korea accounted for 2.7% of the global manufacturing execution systems in life sciences market in 2023.

This guide helps Korean biopharmaceutical manufacturers define MES requirements, evaluate potential vendors, understand the implementation journey, and prepare for future integration with systems like QMS, LIMS, and SCADA.

Section I

MES Selection Criteria for Biopharmaceutical Manufacturing

Category	Key Features	Why It Matters
Regulatory Compliance	Support for 21 CFR Part 11, EU Annex 11 GAMP 5 aligned validation Audit trails and signatures	Required for data integrity, validation readiness, and GMP compliance
Electronic Batch Records	Batch-centric workflows Deviation capture Review by exception	Enables faster, error-free batch release and paperless traceability
Integration Capability	Interfaces for ERP, LIMS, QMS, SCADA, DCS, PAT	Creates data consistency across systems and eliminates silos
Deployment Options	On-premise, cloud native, and hybrid configurations	Offers flexibility aligned with IT and regulatory strategy
Scalability	Multi-site support- Reusable templates and global libraries	Reduces time and cost during expansion or tech transfers
User Experience	Web and mobile interfaces- Role-based dashboards- Low code configuration	Boosts adoption and reduces need for custom development
Localization and Support	Korean UI and documentation- Local partners and in-region support	Enables efficient implementation, training, and system validation
Implementation Efficiency	Structured rollout methodology- Average go-live in 6 to 18 months	Reduces business risk and supports predictable execution

Section II

From Shortlist to Selection: Finalizing Your MES Partner

Once you've shortlisted your potential MES providers, the next challenge is differentiating between them to find the best fit for your operations. The following question-based framework is designed to streamline this evaluation process. It will guide your internal assessment and enable focused cross functional discussions, helping teams align on technical fit, compliance readiness, and long-term scalability.

1. Pharma Readiness

Does the MES support GMP-specific workflows such as weigh and dispense, cleaning verification, and deviation handling?

2. System Interoperability

Can it integrate with ERP, LIMS, QMS, SCADA, PAT, and warehouse systems using APIs or existing connectors?

3. Deployment Fit

Does the solution align with your IT environment—cloud, on-premise, hybrid—and data security requirements?

4. Scalability and Reuse

Can templates, workflows, and validation documentation be reused across products and facilities?

5. Change Management and UX

Is the interface user-friendly for operators and QA reviewers? Does it support browser access and mobile use?

6. Regulatory Alignment

Has the MES been validated in GMP settings? Can the vendor provide audit-ready documentation and support?

7. Implementation Support

Does the vendor offer Korean-language support, local partnerships, and proven deployment experience in the region?

Section III

MES Providers in the Korean Biopharma Market

Section IV

MES Selection and Implementation Roadmap

Section V

Connecting MES with QMS for End-to-End Compliance

Optional Insight: Connecting MES with QMS for End-to-End Compliance

While MES governs execution, the QMS governs broader quality controls such as deviations, CAPAs, training, and audits. Integrating both systems ensures that quality events are triggered and resolved in sync with production activities.

Benefits of Integration

Trigger CAPAs and investigations from MES deviations
Link production and quality data for real-time reviews
Improve batch release time and audit transparency

When to Integrate

Your QMS is already digital (e.g. TrackWise, Veeva, MasterControl)
Batch review cycles are delayed due to manual reconciliation
You’re designing an integrated digital plant roadmap

Tip

Even if QMS–MES integration isn’t part of Phase 1, include it in your digital roadmap. Choose an MES that supports open APIs and is integration-ready.

Building the Digital Backbone for Biopharma Excellence

A well-implemented MES improves visibility, traceability, and compliance, but more importantly, it lays the foundation for connected, data-driven manufacturing. In Korea’s evolving biopharma landscape, where speed, quality, and regulatory readiness are non-negotiable, the right MES supports not just operations, but enterprise strategy.

This guide enables your team to define key requirements, assess the right partners, and chart a step-by-step course toward full MES implementation with long-term digital integration in mind.

References

Körber Pharma Software. (2023). GC Biopharma accelerates digital transformation with fast-tracked MES implementation in partnership with Körber. Retrieved from https://www.koerber-pharma.com/en/press/detail/gc-biopharma-accelerates-digital-transformation-with-fast-tracked-mes-implementation-in-partnership-with-koerber
Rockwell Automation. (2023). Dong-A ST automates pharmaceutical operations with PharmaSuite MES. Retrieved from https://www.rockwellautomation.com/en-us/company/news/case-studies/donga-st-songdo-newplant.html
Singh, S., & Singh, R. (2023). Compliance readiness of MES platforms with 21 CFR Part 11 and Annex 11 in regulated environments. International Journal of Data Science & Machine Learning, 4(2), 1–9. Retrieved from https://www.academicpublishers.org/journals/index.php/ijdsml/article/download/4449/5425/10744
Rockwell Automation. (2024). FactoryTalk PharmaSuite MES for Life Sciences: Product overview. Retrieved from https://www.rockwellautomation.com/en-us/products/software/factorytalk/operationsuite/mes/life-sciences.html
Zaether Digital. (2024). How MES drives growth & efficiency in biopharma: The case for MES–QMS integration. Retrieved from https://www.zaether.com/resources/how-mes-drive-growth-efficiency-in-biopharma/
Grand View Research. (2024). South Korea manufacturing execution system in life sciences market size & outlook. Grand View Research Horizon. Retrieved from https://www.grandviewresearch.com/horizon/outlook/manufacturing-execution-system-in-life-sciences-market/south‑korea

PRE-CONFERENCE WORKSHOP

MASTERCONTROL KOREA USER GROUP

08:30 - 17:15 | 24 September 2025

Join us for an exclusive, full-day interactive workshop where innovation meets execution in the world of digital manufacturing. Designed specifically for senior professionals in biopharma and life sciences, this event offers a deep dive into MasterControl’s AI-powered quality, manufacturing & asset management platform and cloud ecosystem—delivering smarter, faster, and more compliant operations. Gain firsthand access to MasterControl’s latest product roadmap, explore intelligent automation, and experience how connected technologies—from live demos to hands-on platform training—can elevate your organization’s digital maturity. Learn from real-world case studies, hear from industry leaders at Fujitsu Korea and Elemental Machines, and explore how sensors, data, and AI are transforming quality systems on the shop floor. From strategic vision to practical implementation, this workshop delivers a comprehensive journey through the tools, technologies, and insights that will define the next generation of pharma manufacturing, quality & asset management. Whether you're just starting your digital transformation or scaling existing systems, you’ll leave with actionable ideas, valuable peer insights, and a clearer path forward.