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Digital Cleaning Validation

Avoid costly manufacturing delays and stay on the right side of regulators with the only true, end-to-end cleaning validation solution that incorporates all stages of the lifecycle.

Benefits this Solution Provides

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Create a Complete Digital Cleaning Validation Program

Integrate cleaning process design, qualification, and continuous monitoring with systemic change controls.

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Produce Consistent Outputs and Reduce Human Error

Automate activities that adhere to your cleaning validation master plan based on your standard operating procedures (SOPs).

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Stay Audit Ready and Compliant

Dynamically generate master data to create a complete audit trail that is 21 CFR Part 11 compliant.

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Streamline Change Impact Assessments

Set up a one-time framework that walks you through every required consideration for any process or material changes within the cleaning program.

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Determine Risk Exposure and Create a Mitigation Plan

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  • Utilize decision trees, standardized frameworks, and templates to determine the appropriate cleaning process.
  • Assess risk at each step level of the cleaning process.
  • Automatically determine the worst-case product/equipment based on your defined assessment process.
  • Mitigate risk, control how you identify and track deviations, and generate audit trails that keep you compliant. 

Perfect Your Methodology

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  • Use coupon studies to ensure your cleaning methods and procedures are quantifiable, follow your validation master plan, and adhere to your SOPs.
  • Systematically flag out-of-limit values for residual limit acceptance criteria with established limit of detection (LOD) and limit of quantitation (LOQ) values.
  • Ensure consistent standards for worst-case product/equipment, dirty and clean hold times, contact surface areas, and maximum allowable carryover (MACO) calculations. 

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Produce Scientifically Sound Results

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  • Apply reliable manufacturer inputs, such as health-based exposure limits (HBEL), into your cleaning process.
  • Precisely calculate MACO based on criteria configured in your business rules.
  • Systematically calculate contact surface area based on equipment data in your process equipment train (PET) and establish equipment-specific clean and dirty hold times.
  • Confidently perform equipment and product changeover between production runs, ensuring product quality and patient safety. 

What can you expect from implementing our solution?

Before After
No cleaning validation master plan, leaving you vulnerable to human error and increased risk. An approved cleaning validation master plan that establishes controls and reduces error and risk.
Inconsistency of outputs and calculations hinder audit readiness. Enforced standards, consistent processes, and results across sites ensure audit readiness.
Unclear audit trails using manual or disparate tools increase compliance risk. Strict audit trails with immutable time stamps and electronic signature captured in the protocol.
Vague analytical methods apply inconsistent parameters to cleaning results. Clear, quantifiable analytical methods are used to establish acceptance criteria.

Learn More From Our Experts

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Blog Post

Digital Validation

Launching Digital Validation: MilliporeSigma's 97-Day Implementation Success Story

Read the Blog Post

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Industry Insight

Risk and Data as Knowledge Enablers: A Lifecycle Approach

Read the Article

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Webinar

How to Digitally Optimize Comparability for More Effective Post-Approval Change Management

Watch

See how ValGenesis can support your digital transformation.