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Improve Process Understanding, Stability and Product Quality

A large Biotech company was experiencing production issues with two flagship products, and struggling to identify the root causes. They wanted to improve their process understanding, stability and product quality by identifying the critical process parameters and improve process predictability and product quality.

A major impediment to process understanding was that a significant amount of data was only available on paper batch records. They believed that understanding the batch record data would likely reveal the critical process parameters, but they had no validated way to regularly include this data in their investigations. In their search for a solution, they developed business requirements which included:

  • Self-service access to, and timely distribution of, key process information
  • Understanding and control of the factors driving the success or failure of the manufacturing processes
  • Improved process predictability, yields and quality

Paper Record Data Captured using Discoverant PRIMR

The result of their search led to the implementation of Aegis' PRIMR (Paper Record Input ManageR) which allowed them Part 11 compliant capture of their data in electronic form from paper batch records. The browser-based PRIMR input forms were easy to create and modify as needed, yet the system provided them with the flexibility and robustness to work in both validated and non-validated environments. By capturing the data from their paper batch records and also connecting directly to their LIMS, ERP and Historian, Aegis' Discoverant gave them the ability to analyze all the key data much more easily from all the relevant sources. Their PRIMR implementation allowed them to identify and adjust critical process parameters in their manufacturing processes.

Significant, Measurable Payback

Within six weeks of using Discoverant and PRIMR, their improved process understanding allowed them to avoid the loss of two batches, for a total cost reduction of $500,000 per batch.

They also realized that by publishing the results of their Discoverant analyses on a regular basis throughout the company, they were able to collaborate much more effectively and realize additional process improvements at other company sites.