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Digital Continued Process Verification

Experience automatic and effortless process control.

Benefits this Solution Provides

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Swift Implementation

Implement continued process verification (CPV) plans for a large number of products using a simple workflow.

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CPV Automation

Integrate all your systems for registry, collections, and storage of data.

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Always Available

Check process status in real time through monitoring dashboards.

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Effortless Reports

Accelerate and automate report generation without human input.

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Eliminate Manual and Repetitive Work

_________

  • Accelerate continued process verification (CPV) preparation; prepare it in 30 minutes with six mouse clicks.
  • Trigger an alarm every time a threshold is crossed for a variable or control plot; ensure you always know what is happening.
  • Automatically collect all product and process data throughout the lifecycle.

Remove the Subjectivity of Risk Assessments

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  • Perform a risk assessment to easily identify the critical method attributes (CMAs) and the critical method parameters (CMPs).
  • Verify the consistency of the criticality assessments.
  • Evaluate the performance of the control strategy with real-time data evidence.
  • Migrate statistical data to support risk assessments.

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Integrate CPV with the QbD Concept

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  • Support the adoption of systematic approaches to quality risk assessment
  • Ensure that processes are in a state of control in real time.
  • Acquire and communicate knowledge for fact-based decision-making.

What Can You Expect From Implementing Our Solution?

Before After
Research often conducted one variable at a time. Systematic — relates the mechanistic understanding of material attributes and process parameters to drug product (CQA).
Based on an initial full-scale batch; focused on optimization and reproducibility. Adjusted continuously; more robust and allows for the creation of control strategies.
In-process tests primarily for go/no-go decisions. PAT tools are utilized with appropriate feedforward and feedback controls to optimize product performance using supportive, relevant real-time data.
Based on the batch data available at the time of registration. Based on the desired product performance with relevant supportive data.
Drug product quality is controlled by intermediate- and end-product testing. Drug product is ensured by a risk-based control strategy for well-understood product and processess.
Reactive (no alarms). Preventive action (with alarms).

Learn More From Our Experts

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Blog Post

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Leveraging Vendor Testing: A Smarter Approach to Validation

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Industry Insight

Digital CPV for Continuous Manufacturing

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Webinar

Vendor Testing in VLMS: The Value of PDF Execution

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See how ValGenesis can support your digital transformation.