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Digitalizing Pharmaceutical Production with Electronic Batch Records (EBR)

Digitalizing Pharmaceutical Production
with Electronic Batch Records (EBR)

Until now we have produced batch documentation of approximately 150–200 pages per day in this production area that we now do not have to create, print, fill-in, control, and re-control. We are saving approx. 33,000 pages per year or approximately 165 kilograms of paper.

Production supervisorCustomer testimonial

About the customer

The customer is one of the world’s largest pharmaceutical companies. It is headquartered in Japan and operates in more than 70 countries. The company is recognized as a global leader with a strong research focus and a clear commitment to developing innovative treatments in oncology, gastroenterology, neuroscience, and rare diseases.

With tens of thousands of employees and annual revenues exceeding USD 16 billion, the organization maintains high standards for quality, patient safety, and operational excellence. Its manufacturing network follows strict global procedures to ensure compliance and efficiency at every stage of production.

Project scope

At one of the company’s European manufacturing sites, PI-sheets and Electronic Batch Records (EBR) had already been implemented in selected areas. To launch a new product, production teams wanted to extend the EBR functionality to a new production area.

The project’s main goal was to design and implement a new PI-sheet and EBR solution that combined two key steps — weighing of raw materials and mixing of semi-finished products — into one integrated process. The new setup built on existing PI-sheet components to ensure reuse and consistency.

This initiative was part of a broader digitalization strategy for manufacturing operations. It aimed to improve process consistency, reduce manual effort, and increase data integrity across all production lines.

Akselera’s role, deliverables and results

Akselera provided solution architecture and SAP PP-PI expertise throughout the project. Our consultants worked closely with TechWeaver and the customer’s production and quality teams to implement a complete electronic process for raw material weighing, semi-finished material mixing, and batch documentation.

The new EBR solution increased automation and made production data instantly available for quality review. The system also flagged deviations directly in PI-sheets and inspection lots, such as incorrect equipment use or out-of-limit results. As a result, deviations were detected and resolved faster, improving both traceability and data quality.

The project delivered measurable improvements. Lead times decreased because production and quality review could run in parallel. Collaboration between teams improved, and the risk of losing paper documentation disappeared entirely. In addition, automated data validation reduced manual entry and control, saving time and minimizing human error.

Through this implementation, Akselera helped the customer strengthen compliance, enhance efficiency, and accelerate production workflows. The project became an important milestone in the company’s digital manufacturing transformation.

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