Eirgen Pharma is pleased to announce a significant development in our ongoing digital journey. In Q2 of the current year, we commenced development of our new Electronic Batch Record (EBR) system, internally known as Project Elevate. This initiative represents a strategic transition from traditional paper-based processes to a fully digitized system, with an anticipated launch in Q4 of 2025.

Strategic Objective of Project Elevate

The implementation of Project Elevate signifies a substantial improvement in our digital infrastructure. For this transformative project, we have partnered with a manufacturing technology company, Tulip Interfaces, and an IT Solutions Provider, NNIT.

This collaboration will empower our operations of workflow, automation of data collection, and the delivery of real-time insights directly from our production environment. The digitization of our batch record management is designed to yield increased operational efficiency and ensure regulatory compliance. Furthermore, the initiative underscores our commitment to maintaining the highest standards of quality throughout all stages of production.

Dan Delaney, Head of Operations at Eirgen Pharma, shared his enthusiasm for the project.

“I am very proud of the team’s dedication in bringing Project Elevate to fruition. This new EBR system will be a transformative asset for our manufacturing processes. It directly contributes to enhancing data integrity, streamlining our operations across the board, and elevating our compliance framework.

It also brings a fantastic environmental and sustainable aspect to what we do, by ensuring our new facility is on its way to being a paperless building. This is a significant step forward in our digital infrastructure and operational excellence right here at Eirgen.

Anticipated Benefits of Project Elevate for Eirgen Pharma

Project Elevate is expected to deliver several key benefits to Eirgen Pharma.

1. Enhanced Traceability of Batches

   This system will provide real-time insights into our production processes, ensuring greater control and transparency over every batch from raw material to finished product.

2. Quicker Batch Releases

   By automating data collection, streamlining review processes, and facilitating "review by exception", the electronic batch record system will significantly reduce the time required for batch review and release.

3. Streamlined and Functioning Operator Workflows

   The digital platform will guide operators through each step of the manufacturing processes, ensuring consistent adherence to procedures, reducing manual errors, and generating precise, immediately accessible workflow records.

4. Quality

   The system's inherent controls, automated checks, and robust data integrity features will significantly mitigate risks to product quality, supporting our "right first time" approach to manufacturing.

5. Positive Environmental Impact

   A core objective for our new facility is to operate a completely paperless building, thereby significantly reducing our environmental footprint and contributing to a more sustainable future.

Speaking about the project, Nils Arne Jonescheit, Managing Consultant and Low Code SME at NNIT, said, "NNIT and Eirgen collaborated closely throughout this process to ensure a successful and sustainable transformation."

Dan added," This is a significant step forward in strengthening our digital infrastructure and driving operational excellence here at Eirgen. It also supports our environmental and sustainability goals by helping us move towards a paperless facility."

A Vision for a Paperless Future

Beyond the immediate efficiencies and operational enhancement it brings, a core objective of Project Elevate is to usher in a completely paperless future at our new facility. This isn't about modernizing our processes - it's a commitment to intertwining our drive for operational excellence with our deep-seated sense of environmental responsibility.

Historically, pharmaceutical manufacturing, with its rigorous documentation requirements, has been a paper-intensive industry. Batch records, quality control logs, equipment maintenance forms - the sheer volume of physical documentation can be staggering. While essential for compliance and traceability, the reliance on paper comes with inherent challenges - storage, retrieval, the potential for human error, and a significant environmental footprint.

Our new Electronic Batch Record (EBR) system directly addresses these challenges. By digitizing critical manufacturing data and processes, we are moving away from manual, paper-based entries.

Looking ahead, Dan said, ""Thank you to everyone who has contributed to this transfer so far. And a big thank you to the teams at Tulip Interfaces and NNIT for their invaluable assistance in getting this system to the beginning of this journey. We look forward to seeing this system evolve and grow, driving further efficiency, sustainability, and success for Eirgen.”

We look forward to pushing the go-live button on our new EBR interface in production in Q4 of 2025.