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Quality and Compliance for Life Sciences

Drive Performance and Lower Patient Risk by Creating a Truly Connected Enterprise
A medical professional at the hospital bedside of an elderly patient finishes placing an intravenous catheter in the patient's arm.
Quality and Compliance for Life Sciences
Drive Performance and Lower Patient Risk by Creating a Truly Connected Enterprise

Real-time Quality and Streamlined Compliance

We work with you to make it a reality, providing solutions so you can digitize your organization while maintaining compliance and ensuring quality. With the right tools in place, you’ll forge strong connections between every link in your supply chain so you can make informed decisions that:

  • Decrease risk of human error with digitized processes from lab to production
  • Lower the cost of quality with less time spent on review
  • Reduce risk at every stage in the supply chain
  • Use data to speed batch release and cut waste
  • Ease compliance reporting to meet the demands of increasingly dynamic audits
Discover How an MES Powers Improvements

Part Ways with Paper Trails

“An EBR solution is the GPS of manufacturing operations. It guides the user to the desired destination, finds the shortest trip, alerts one to dangers, and feeds them back in real time.”

- Jerome Repiton, Ferring Pharmaceutical

What can an EBR system do for you?

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Decrease in batch-review cycle times

80%

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Decrease in investigations

50%

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Fewer manual entries

70%

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Fewer entry mistakes

90%

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Increase in stock turnaround

50%

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Optimize Batch in a Connected Environment Demo
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Video
Optimize Batch in a Connected Environment Demo

Integration of MES and DCS streamlines view and operations for workers, easing production, compliance, reviews, track-and-trace, etc.

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MES: The Heart of your Digital Transformation

Only a holistic approach to digital transformation can help you thrive today and be ready for tomorrow. With the right manufacturing execution system (MES) as the foundation, you'll give your project a solid start.

When choosing to design your system at the MES level – instead of the machine or enterprise levels – you enable seamless integration up to the ERP systems and the cloud, and down to the production line. Our FactoryTalk® PharmaSuite® software delivers that capability, which is why it’s the most adopted MES solution across all disciplines of life sciences manufacturing.

Start your digital transformation with MES for Life Sciences

A leading API manufacturer reduced time to qualify by 30% by connecting disparate systems, giving visibility and access to real-time information for faster decision-making.

 

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Enable Real-time Release and Issue Resolution

Looking to lower the cost of quality with less time spent in review? We can work with you to use data as a business driver to speed batch release and cut waste. Boost your production quality and compliance with the ability to:

  • Communicate up-to-the-minute information to and from equipment, operators and supervisors
  • Automate analysis of production data and exception-based review, significantly reducing supervisory and QA batch product review time
  • When efficacy requirements or tolerance is off, pinpoint affected batches to avoid discarding product that meets quality standards
Catch Bad Products Early with Quality Dashboards
Quality Dashboard on tablet
Webinar
Catch Bad Products Early with Quality Dashboards

Has quality become more of a guessing game, than a science?

Watch On Demand

A global pharma company improved production by 65% across 50 facilities through integration of acquired facilities and systems.

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Savings potential per facility

$10M

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Validation down from 2 weeks to

2 hours

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Dramatic reduction in batch losses

80%

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Drive Operational Consistency with Enterprise-wide Standards

The rapid evolution of the Industrial Internet of Things (IIoT) means you can take significant steps toward digitalizing operations. But this greater connectivity and complexity puts validation, quality and compliance at risk.

Leading life sciences manufacturers have solved this through standardization and a foundation of Good Manufacturing Practice (GMP), enabling them to:

  • Leverage MES to roll out consistent quality processes and procedures across their plants
  • Implement rules that result in real-time changes to processes at scale
  • Monitor and enforce work-in-process on the factory floor in real time
Med Device Maker Increases Throughput 230% with Manufacturing Intelligence
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Case Study
Med Device Maker Increases Throughput 230% with Manufacturing Intelligence

Integrated control and information system also helps reduce scrap and cycle time.

Find Out How
Beyond Data Integrity
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Blog
Beyond Data Integrity

Data contextualization enhances the overall integrity of a batch record – and improves real-time business outcomes.

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We offer industry expertise to help design, implement and support your automation investment.

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