Insights

AI in pharma is making headlines, from predicting process deviations to accelerating drug development. But here’s the challenge: AI is only as powerful as the data behind it. And that’s where most pharma companies fall short. 

Without foundational systems like Manufacturing Execution Systems (MES) and Electronic Batch Records (EBR), AI can’t deliver. This post explains why MES and EBR aren’t just helpful, they’re essential to any AI or digital transformation initiative in pharmaceutical manufacturing. 

This blog explores why MES and EBR are the real starting point for AI readiness and how they build the essential foundation for digital success in pharmaceutical manufacturing. 

 

What Are MES and EBR, and Why Do They Matter for AI? 

A Manufacturing Execution System (MES) connects the shop floor to enterprise systems, offering real-time control and visibility over workflows, equipment, personnel, and materials. 

An Electronic Batch Record (EBR) digitizes the batch documentation process, eliminating paper-based records and ensuring accuracy, compliance, and efficiency. 

But beyond efficiency, these systems generate structured, standardized, and validated data. In other words, the kind of data that enables machine learning, predictive analytics, and real-time decision-making. If you want AI to optimize your process, it needs to understand that process first. MES and EBR make that possible. 

 

Simply put: No MES or EBR? No clean data. No clean data? No meaningful AI. 

 

The Problem with Paper: AI Can’t Read Handwriting 

Many pharmaceutical companies still rely on manual systems to run highly complex, regulated processes. These paper-based methods slow everything down, from batch reviews to audits, with human error at nearly every step. 

But even worse: they produce unstructured, inconsistent, and inaccessible data. AI thrives on digital clarity. Paper gives it noise. 

This is why companies like Lupin turned to Werum PAS-X MES to enable paperless manufacturing at their Nagpur facility. With structured digital processes, Lupin gained better compliance, faster operations, and—most importantly—a usable foundation for future data-driven strategies (source below). 

 

MES/EBR: The starting point of the AI Ecosystem 

MES and EBR aren’t the end goal. They’re the starting infrastructure of a digitally intelligent biopharma operation. Here’s how they lay the groundwork for AI: 

• Real-time visibility: AI needs up-to-date process signals. MES makes them available. 

• Structured batch data: EBR standardizes critical production information AI can learn from. 

• Integrated systems: MES connects ERP, LIMS, and QMS so AI has a unified view. 

• Automated compliance: AI can’t fix what’s broken. MES/EBR reduce human error at the source. 

• Data integrity: AI models require clean, contextual data. MES/EBR provide it. 

UCB Pharma chose Emerson’s Syncade MES and DeltaV DCS to consolidate process data across systems, minimizing project risk and enabling smarter recipe and production control (source below). Similarly, AstraZeneca rolled out Werum PAS-X MES globally to harmonize operations and improve data integrity. That’s not just operational alignment, it’s AI preparation (source below). 

 

MES/EBR in Practice: Building the Foundation First 

Many companies eager to “go digital” rush toward dashboards, cloud analytics, or AI pilots. But without the structured operational layer that MES and EBR provide, these efforts fail to scale, or deliver superficial insights at best. 

The smarter approach is the one taken by companies like: 

• Cipla, which implemented EBR at its Patalganga site to streamline documentation and boost batch throughput (source below). 

• Siemens Opcenter Execution Pharma clients, who replaced paper with full digital batch execution to reduce human error and enable faster product release (source below). 

These companies aren’t chasing AI, they’re building toward it. 

 

MES and EBR Are the Foundation. AI Is the Future. 

To fully realize the promise of AI in pharmaceutical manufacturing, you must first gain control of your processes and your data. That’s exactly what MES and EBR enable. 

They don’t just digitize, they structure, standardize, and synchronize the manufacturing environment. They make your operations visible, your data usable, and your future scalable. 

AI needs a foundation. MES and EBR are that foundation. 

 

MES and EBR aren’t just IT upgrades, they’re your launchpad for intelligent operations. If your AI initiative isn’t delivering, maybe it’s time to look at your foundation. 

Is your manufacturing data AI-ready? Let Zaether show you how to get there.