コンポーザブルMESへの移行：生産効率とGxP の新たな基準

For decades, the path to production efficiency seemed linear: standardize processes, invest in automation, and deploy a centralized MES to manage execution.

Plenty of manufacturers followed that path. They spent heavily on software licenses, customization, and system integrators.

Yet many operations teams now feel stuck. Change takes too long. Local teams work around the system instead of with it. What was supposed to bring consistency is now slowing execution.

The issue stems from the underlying design. Traditional MES platforms were built for environments where processes stayed the same for long stretches of time.

That assumption no longer holds. High mix production, frequent product changes, evolving regulatory requirements, and ongoing workforce turnover demand systems that can adapt without months of rework.

Today, the market is shifting. Manufacturers are moving away from large, tightly coupled MES deployments and toward a composable approach. These architectures break execution into smaller, purpose-built components that can change independently. Teams can adjust workflows, add new capabilities, and respond to operational issues without destabilizing the rest of the system.

For operations leaders, this shift is less about chasing new technology and more about removing friction from daily work. The goal is simple: Give plants the ability to evolve at the pace the business requires without rebuilding the foundation every time conditions change.

To understand why legacy MES struggles to enable practical efficiency, you have to look at how they were built.

従来のシステムの多くはモノリシックな構造で設計されています。つまり、大規模で相互に接続されたコードの集合体であり、各機能が他のすべての機能と直接的に結びついているのです。

In this model, the quality module is inextricably linked to the scheduling module. While this sounds cohesive in a sales presentation, in practice, it creates a rigid house of cards. If a plant manager wants to add a single data field to a quality check, that change ripples through the entire codebase.

This architectural rigidity enforces a waterfall change management process. Because the risk of breaking the system is high, every update requires extensive regression testing, IT approval, and vendor intervention. The result is a system that remains static while the production floor evolves.

The Integrator Tax and Other Hidden Costs

One of the most significant hidden costs of a monolithic MES is not the licensing fee; it is the "Integrator Tax."

Because legacy systems often use proprietary coding languages and complex data schemas, the typical process engineer is unable to modify them. This forces manufacturers to rely on third-party system integrators for even minor adjustments.

経済的現実：

• 高摩擦：単純なワークフローの変更で、本来なら半日で済む作業が、しばしば数週間にわたる範囲定義やSOW（作業範囲）の交渉を要します。

• 予算の浪費：残業代予算の相当部分が、革新への投資ではなく現状維持に費やされています。

• Skills Gap: The knowledge of how the system works sits outside the company, leaving the manufacturer vulnerable if the integrator relationship ends.

A Frontline Operations Platform like Tulip fundamentally inverts this model by leveraging a composable architecture. Instead of a single, rigid block, the architecture consists of modular applications that share a common data model.

This approach democratizes technical capability. Features like a no-code app builder enable process engineers to build and modify applications without breaking the core system. The data is not locked in a proprietary silo; it is accessible via open APIs, allowing for real-time connection to the rest of the tech stack.

When reliance on integrators is removed, the cost of curiosity drops to zero. Engineers can experiment with new workflows, test efficiency improvements, and deploy updates in real-time, restoring the agility that the monolith stripped away.

A common failure mode in digital transformation is simply digitizing existing friction. Legacy systems often present operators with static PDF forms or complex data entry fields displayed on a screen. This may technically “digitize” data collection, but it definitely does not improve execution.

True production efficiency requires human-centric guidance. A modern platform should enable native computer vision and IoT connectivity to actively assist the operator, reducing cognitive load rather than adding to it.

This shift transforms the operator's role from data entry clerk to value-added problem solver, directly impacting uptime and yield.

For example, Laerdal Medical used a vision-based approach to error-proof their assembly lines, using cameras to verify component placement in real-time.

90日間のROIベンチマーク

In the legacy software world, value is measured in years. A typical electronic batch record (eBR) or global MES rollout involves a 12 to 24-month implementation cycle before a single site goes live.

Composable ecosystems operate on a fundamentally different timeline. Because manufacturers can deploy apps iteratively (starting with a specific line, machine, or use case) the time-to-value shrinks dramatically.

The New Standard: A validated, functional system should be able to deliver ROI in under 90 days.

This timeline is achieved by solving specific problems first. Rather than boiling the ocean with a massive, site-wide deployment, operations teams can deploy a targeted app to solve for a critical bottleneck.

For example, terminal tractor manufacturer TICO started with a single, narrowly scoped use case: digital work instructions. Instead of a plant-wide MES rollout, they deployed Tulip to replace paper and Excel-based instructions at a small number of assembly stations.

Within the first 90 days, operators were using step-by-step, image-driven guidance that cut onboarding time from months to days and eliminated constant reprinting and version control issues. That initial win established immediate ROI and built a foundation for incremental expansion into BOM management, production tracking, and quality—scaled over time, one problem at a time.

第1四半期に価値を実証することで、製造業者は初期パイロットによるコスト削減効果を資金源とし、その後の拡張を推進することが可能となります。これにより、財務モデルは高リスクな設備投資から自己資金による拡張へと転換されます。

ライフサイエンス分野のリーダーの皆様にとって、新技術の導入を躊躇される背景には、コンプライアンスリスクがしばしば存在します。GxP において、モノリシックMES 検証は膨大な作業MES 。システムが単一の連続したコードブロックであるため、更新のたびにスタック全体の再検証が必要となるからです。

This creates validation paralysis. Manufacturers frequently choose to run an outdated version of their software for years simply to avoid the massive documentation burden of an upgrade.

コンポーザブルプラットフォームはパラダイムシフトをもたらします：プラットフォーム中心の検証です。このモデルでは、検証の負担が共有されます。ベンダーは基盤となるプラットフォーム機能（監査証跡、電子署名、ユーザー管理）をリリースサイクルの一環として検証します。製造メーカーはその後、自社が構築または変更した特定のアプリケーションのみを検証します。

この対象を絞ったアプローチにより、検証作業の範囲が大幅に縮小されます。これにより、品質管理チームは厳格な21 CFR Part 11準拠を維持しつつ、運用チームにはプロセス改善の自由度を提供することが可能となります。

例外レビュー方式への移行

In legacy operations, batch release is a bottleneck. Quality assurance teams often spend days reviewing stacks of paper records or scrolling through static PDFs to verify that every step was completed correctly.

A connected platform enables review by exception. Because the apps enforce logic at the point of execution, preventing an operator from proceeding if a value is out of spec, the system guarantees that data entry is correct by default.

Quality teams no longer need to review every single data point. Instead, the system flags only the deviations and quality alerts for review. This shift allows manufacturers to move from retrospective quality control to real-time quality assurance, while greatly accelerating batch release cycles.

The future of manufacturing belongs to the agile. As production demands become more complex and regulated, the rigid structures of the past are giving way to the flexible ecosystems of the future.

By adopting a composable MES strategy, manufacturers can escape the integrator tax and multi-year rollouts. They can build an operation that is compliant by design, human-centric by default, and capable of adapting at the speed of the market.

If you’re interested in seeing how Tulip’s composable MES can help you streamline compliance and improve efficiency, reach out to a member of our team today!