New Standard for MES and Data Innovates the Pharma Industry

Data as bottleneck

Data is one of the biggest bottlenecks in pharma. Organizations are still largely siloed. They progress through different stages—from early development, through process development, to commercial production. Data exchange between these blocks is cumbersome, even though this is precisely where the gains lie. A concrete example: at a large pharmaceutical multinational, eight people were needed to manually retype batch brackets—a task that could be far better spent on development and quality improvement. Problems like this are seen across the industry.

Smart digitalization allows organizations to connect processes and data from research to distribution. This results in faster insights, shorter lead times, and better control of variations.

MES: From monolithic to modular

Pharma companies often stick to traditional MES systems. These systems are expensive, cumbersome, and poorly suited to varying processes and production volumes, especially during development. Traditional MES implementations in the pharmaceutical industry are characterized by high licensing costs and vendor lock-in, slow change lead times, limited flexibility for different production types, and complex integrations with existing systems.

Modular MES Architecture

Instead of one large, fully integrated MES system, ICT Group deliberately opts for a modular configuration. We combine electronic batch recording with separate planning and equipment modules, supplemented by a standardized data layer. This makes the entire process much more flexible, cost-effective, and, above all, future-proof. 

The benefits of a modular approach are becoming increasingly clear in practice. For example, we see that organizations, depending on complexity and validation requirements, often benefit from shorter implementation times compared to traditional approaches. In addition, a phased rollout is possible, allowing electronic batch recording modules, for example, to become operational sooner. The architecture offers flexibility for both pilot plants and commercial production, while GMP/GxP compliance is guaranteed through risk-based validation.

A modular approach offers greater flexibility than traditional MES systems. Dashboards and modules can often be developed faster than in monolithic systems. With modern technologies, including AI support, the development time of certain components can be significantly reduced. It is important, however, that underlying data quality and governance are in order.

Modular Data Landscape: The Backbone of Digitalization

The next challenge: how do you connect all the data floating around within a pharmaceutical organization? In many pharma organizations, data is still on paper. Laboratories and production often operate separately. Combining data from various silos remains a challenge. This fragmentation leads to manual retyping of critical data, long reporting lead times, limited data analysis capabilities, and an increased risk of errors.

Unified Namespace and Data Lakes

One possible solution offered by ICT Group is a data backbone using a Unified Namespace. An event-driven context layer, better known as Unified Namespace, connects systems based on publish/subscribe patterns. This is then combined with a data lake for historical storage, reporting, and modeling.

This architecture provides:

• Consistent context between R&D, production, and quality
• Fewer point-to-point integrations, resulting in lower complexity
• Faster data reuse between departments
• Real-time insights instead of batch reporting
   

ICT Group is an all-round partner—from strategy to technical execution. We manage the entire process, from consultancy and implementation to maintenance. From AI to sensor implementation, we understand the technology, the segment, and the processes.

Ready for Digital Transformation? 

Discover how ICT Group can help your pharma organization with digital transformation. Contact Michel van Heumen for an exploratory conversation.

ICT Group: from cybersecurity to AI, from strategy to implementation – your partner for holistic digitalization in Pharma.