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Process Troubleshooting

Stop wasting resources without getting results. Start using your data smartly to discover the root cause of a problem and its solution — fast.

Benefits this Solution Provides

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Draw on Solid Expertise

Profit from our robust experience in pharmaceutical process troubleshooting.

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Reduce Troubleshooting Time

Identify your problem and get a proposed solution within the required timeframe.

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Reduce Workload

Allow your team to remain focused.

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Ensure Compliance

Align with ICH Q9 and other relevant guidelines.

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Take a Specialized Approach

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  • Gain a thorough understanding of your processes and the challenges that could impact compliance to find the root cause of your issue.  
  • Benefit from our decades of experience and innovative technology to save time and resources. 

Address the Root Cause

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  • Use a wide range of root cause analysis tools, such as the Five Whys, Fishbone/Ishikawa Diagram, Cause and Effect Matrix, and Failure Mode and Effects Analysis (FMEA), to determine the cause of any process defect or inefficiency.  
  • Use advanced data analysis (e.g., MVDA) to unlock the value of your product and process data as an investigation tool. 
  • Develop a subsequent corrective and preventive action (CAPA) plan to improve process performance. 

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Achieve Continuous Improvement

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  • Use the knowledge gained from the analysis to uncover new opportunities to optimize your processes for maximum efficiency. 
  • Build control strategies that will increase long-term process robustness. 

What Can You Expect From Implementing Our Solution?

Before After
Try to address process deviation without having a complete understanding of the process. Use state-of-the-art root cause analysis tools and data analysis to identify the cause of your process deviation.
Waste time and resources without getting the expected results. Solve your problem within the timeframe needed while saving resources.
Uncover only the issue being addressed. Discover opportunities for continuous improvement of your processes.

Learn More From Our Experts

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Blog Post

Pharma 4.0

Validating Pharma 4.0 for Smart Manufacturing

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Industry Insight

Risk and Data as Knowledge Enablers: A Lifecycle Approach

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Webinar

Cleaning Validation Programmes: Establishing a Compliance-Led Framework

Watch

See how ValGenesis can support your digital transformation.