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Reduce Process Variability

A leading Pharmaceutical company was struggling with process variability in a complex step in their manufacturing process. This variability led regulatory inspectors to question the company's specification limits and their ability to manufacture the product reliably. The product generated over $3B of revenue annually so it was critical to find a solution.

Looking beyond process variability, they developed the following business requirements:

  • Reducing the impact of adverse product trends through earlier identification
  • Discovering process issues proactively
  • Supply Chain Management through reduced cycle times, leaner inventories, more predictable yields, and shortening batch release time

Although data could be collected manually from their LIMS and SCADA systems, they had no way to connect all this data within a single production run. They also knew that they needed to work with both discrete and continuous data in a meaningful way if they were going to identify the sources of variability in their process.

In their analysis of available solutions, they determined that Aegis' Discoverant / PRIMR uniquely provided:

  • On-demand access for end users to multiple data sources and data types
  • Easy to configure entry forms for capturing critical paper record data
  • Powerful investigational data analysis functions
  • Validatability for both data entry and analysis results

Reduced Process Variability Produced other Benefits

Discoverant enabled them to work concurrently with all data types - discrete, replicate and continuous as well as volumes of data from their paper batch records. This allowed them to quickly understand the sources of process variability and adjust the process to improve control. Within 30 days of their Discoverant implementation they were able to achieve the following results:

  • Reduction in time required for manufacturing investigations, leading to decreased process variability and shorter cycle times
  • Ability to include data from paper batch records in performance analysis and other key plant management reports
  • Increased overall manufacturing productivity