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Take “Review by Exception” to the Next Level

It’s common sense that it’s both faster and easier to review exceptions than the whole.

“Review by exception” methodology is rooted in this logic and is commonly employed to speed disposition of pharmaceutical batch records.

State-of-the-art manufacturing execution systems (MES) enforce various controls throughout execution to ensure that each batch is produced within its control space, especially true for critical process and quality attributes.

As a consequence, review need focus solely on exceptions rather than the entire batch record.

But why stop there? Review by exception methodology offers additional benefits beyond speed and simplification.

With the use of modern dashboards, manufacturers can gain real-time notification of exceptions, enabling them to take preventative action.

Too frequently, we see review processes that wait to begin until all major process steps have completed.

This approach misses the opportunity to understand issues as they emerge, and to intervene in the moment that exceptions are recognized.

By coinciding the start of the review process with identification of an exception, manufacturers can bring review by exception to the next level.

Dashboards deliver real-time notification and easily digestible hands-on information to users.

They can raise a red flag within a Batch Record Review dashboard at the exact moment MES detects an exception, to:

  • Potentially save an expensive batch by identifying an exceptional situation that needs immediate process interaction
  • Avoid development of incorrect conclusions on the shop floor by clarifying criticality of a raised exception
  • Recognize a critical drift of a process right away, triggered by the exceptional violation of a quality critical attribute, perhaps during In-Process-Control (IPC)
  • Enable collection of important contextual information while the event(s) is still fresh in the operators’ minds

Modern dashboards can take review by exception to the next level. Are you ready to take your application to the next level too?

For more information, check out our free webinar.

And, for more information about review by exception, EBR and more, check out our eBook, Beyond Compliance: The Evolution of Pharmaceutical MES.


Martin Dittmer
Martin Dittmer
Product Manager, Rockwell Automation
Martin Dittmer
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