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Batch Performance Analytics

Improve batch performance with actionable process insights
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The Life Sciences Industry is tasked to keep up with demand while maintaining quality and meeting regulatory requirements. Each batch must meet quality and safety standards. Are you meeting the Golden Batch standard every time? 

89.9%

Class 1 & 2 recalls are assocaited with manufacturing or product quality issues
 

Source FDA Drugs Recall Statistics

1,279

avg. FDA recalls/year mostly associated with manufacturing or product quality issues

Source FDA Drug Recall Statistics

80%

Batch failures due to contamination, operator error, equipment failure, failure to meet specs.

Source Biotech Facilities Average a Batch Failure Every 40.6 Weeks - BioProcess International


Introducing Batch Performance Analytics

Batch Performance Analytics helps consistently produce batches with set specifications, quickly identifying contributing factors in production variability and helping to improve regulatory compliance by automating data collection, analysis, and reporting of continued process verification. 

Turn operational data into actionable insights

Does your Life Sciences process struggle with:

  • Keeping track of all the variables involved in complex formulations?
  • Getting feedback on manufacturing efficiency from siloed systems?
  • Tracking and reporting on quality assurance and regulatory affairs

Batch Performance Analytics helps you:

  • Unlock the Golden Batch
  • Improve compliance through automated continuous process verification (CPV)
  • Streamline the manufacturing life cycle

Improve operational performance through enterprise-level analytics

Cloud native

Break through your data silos to make more actionable decisions

connected group

Multi-tenant

Reduce complexity and lower Total Cost of Ownership

Multi-site

Gain real-time insights across your operations


Unlocking the Golden Batch

Define multi-level KPIs (for critical production steps and for the overall batch) for example quality, yield, throughout and cycle time.

  • Tie KPIs to PP/CPP and COAs
  • Collect historical data
  • Configure KPIs/Set the Golden Batch
  • Drill down to analyze single KPIs
  • Compare batches across sites
  • Compare current batch KPI to the Golden Batch KPI (for example quality and cycle time)
  • Receive alerts and adjust process parameters

See what our experts have to say about smart batch processing and Golden Batch.

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Golden Batch Manufacturing: A Golden Opportunity
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ARTICLE
Golden Batch Manufacturing: A Golden Opportunity

Today we want to explore the mechanics of manufacturing and when to know if it's right for your organization to implement Golden Batch manufacturing.

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