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Process Validation

Overcome process validation complexity from design to commercial production while establishing scientific evidence you can deliver a safe, high-quality product.

Benefits this Solution Provides

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Create a Single Source of Truth

Capture and track all critical quality attributes and process performance qualifications.

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Leverage a Holistic Platform

Cover the three stages of process validation: process design, process qualification, and continued process verification.

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Implement a Risk-Based Approach

Enact risk assessment and mitigation planning for process design, considering your CMAs, CPPs, and CQAs.

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Build and Implement a Process Validation Master Plan

Drive all stages of process validation and enforce the required studies and deliverables with associated dependencies.

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Improve Data Integrity

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  • Dynamically collect the critical control points as scheduled, with immutable time stamps.
  • Update batch records automatically to eliminate manual data entry errors and provide the highest degree of data confidence.
  • Statistically determine process confidence and batch success probability.

Collaborate Across the Lifecycle

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  • Establish standard acceptance criteria for consistent processes, improving data application across the enterprise.
  • Eliminate data silos between process validation stages.
  • Share knowledge and data across all business units and locations to facilitate true collaboration within the solution.

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Expedite Cycle Times and Process Turnarounds

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  • Eliminate the delays associated with paper-based authoring, review/approval, and protocol execution workflows.
  • Simplify data collection and retrieval, batch identification, control chart creation, and statistical reporting.
  • Streamline the impact assessment of any change in your process and automate the necessary revalidation workflow.

What Can You Expect From Implementing Our Solution?

Before After
Manual audit trails make verification difficult. Inspection-ready audit trails track all steps and edits with immutable time stamps, making verification easy.
No validation master plan leads to process variations. An approved validation master plan enforces the required studies and deliverables at all stages while tracking dependencies.
Audit preparation is burdensome due to archival retrieval and missing documentation. Audit readiness is guaranteed with easy digital retrieval of fully compliant documentation.
Manual workflows result in missed or skipped steps. Automated workflows remove the potential for human error because each step is clearly assigned.

Learn More From Our Experts

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Blog Post

Process Validation

Best Practices for Process Validation in the Pharmaceutical Industry

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

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See how ValGenesis can support your digital transformation.