Case Study

UST's redesign boosts batch record accuracy and efficiency leading to 70% error reduction for pharma giant

OUR CLIENT

Our client is a leading global biopharmaceutical company dedicated to researching, developing, and supplying innovative medicines to overcome serious diseases. Headquartered in New Jersey, in the United States, the company consistently ranks among the top corporations on the Fortune 500 list. Founded in the late 1800s, it generates approximately $50 billion in annual revenue and specializes in developing biologics and prescription pharmaceuticals across multiple therapeutic areas.

THE CHALLENGE

Overcoming process limitations: Redesigning MES implementation to enhance batch record efficiency

Our client recently introduced a new manufacturing execution system (MES) for a single step in their production process. However, the project was constrained by a focus on preserving the original process and continuing the use of paper-based batch records.

As a result, the implementation only partially achieved its objectives, with efficiency gains in both batch record documentation and operational improvements falling short of expectations. The failure to update the electronic batch record (EBR) design alongside the MES resulted in a low return on investment, as the desired outcomes were not met.

After a thorough review, the client recognized that insufficient planning had been allocated to the MES design phase. To correct course, a new project was initiated with a specific emphasis on optimizing the batch record process, targeting a 50% reduction in batch record review time.

THE TRANSFORMATION

Streamlining compliance and efficiency: UST’s redesign of the batch record system for optimized performance

UST was engaged to lead the redesign of the client's batch record system, focusing on balancing these three critical factors to ensure success:

1. Regulatory compliance: The redesign needed to accommodate strict regulatory constraints that limited changes to the batch record, ensuring compliance with industry standards.
2. MES capabilities: The solution had to fully leverage the capabilities of the existing MES while aligning with the client's operational goals.
3. Efficiency goals: A key objective was to reduce batch record review time by 50%, significantly improving operational efficiency.

UST's approach involved creating an automated data retrieval system to capture key process variables, reduce manual input, and minimize errors. Additionally, the batch record structure was overhauled to eliminate redundant operator entries, streamlining the process without compromising data integrity. This redesign not only improved the review process but also enhanced overall production efficiency, providing a scalable solution for future needs.

THE IMPACT

Achieving 70% error reduction and 40% fewer investigations: Transforming batch record efficiency with UST

Following the successful implementation of UST's redesigned batch record system, supported by enhanced MES capabilities, the client experienced significant operational improvements.

The number of documentation errors was reduced by 70%, resulting in more accurate and reliable records. Additionally, batch record review times dropped by 70% for error-free records, greatly accelerating the overall production process.

The streamlined approach also led to a 40% reduction in investigations, further minimizing delays and freeing up resources for higher-value tasks. This transformation not only improved compliance and operational efficiency but also created a scalable framework for continued growth and optimization.

Discover how UST's expertise can streamline your MES implementation and improve efficiency.

RESOURCES

https://www.ust.com/en/industries/healthcare

https://www.ust.com/en/biopharma-e-book

https://www.ust.com/content/dam/ust/documents/Brochure-UST-Sentry-Vision-AI.pdf