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
Create a Single Source of Truth
Capture and track all critical quality attributes and process performance qualifications.
Leverage a Holistic Platform
Cover the three stages of process validation: process design, process qualification, and continued process verification.
Implement a Risk-Based Approach
Enact risk assessment and mitigation planning for process design, considering your CMAs, CPPs, and CQAs.
Build and Implement a Process Validation Master Plan
Drive all stages of process validation and enforce the required studies and deliverables with associated dependencies.
Improve Data Integrity
Collaborate Across the Lifecycle
- 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.
Expedite Cycle Times and Process Turnarounds
- 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?
|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.|
|Before||Manual audit trails make verification difficult.|
|After||Inspection-ready audit trails track all steps and edits with immutable time stamps, making verification easy.|
|Before||No validation master plan leads to process variations.|
|After||An approved validation master plan enforces the required studies and deliverables at all stages while tracking dependencies.|
|Before||Audit preparation is burdensome due to archival retrieval and missing documentation.|
|After||Audit readiness is guaranteed with easy digital retrieval of fully compliant documentation.|
|Before||Manual workflows result in missed or skipped steps.|
|After||Automated workflows remove the potential for human error because each step is clearly assigned.|
See how ValGenesis can support your digital transformation.