The Benefits of Digitizing Cleaning Validation
Complete cleaning validation management: ValGenesis automates the cleaning validation lifecycle by integrating all stages of cleaning validation, from design and development to validation to continuous monitoring.
Connected processes: Our VLMS seamlessly integrates with complementary solutions such as our process validation solution and equipment and instrument validation solution. Additionally, lab instruments and equipment can be easily integrated to provide real-time capturing of sample test results from laboratory instruments and cleaning process parameters from equipment into the cleaning validation protocols. Connected processes allow for more accurate tracking of changes and approvals.
Increased regulatory compliance: Our solution dynamically creates the process equipment train (PET) and equipment grouping using product, equipment, and manufacturing master data creating a complete audit trail that complies with regulatory requirements.
Risk-based approach: With ValGenesis, you can perform risk assessments at the equipment, drug product, cleaning process, and cleaning procedure levels. The solution automatically calculates the risk score for a product and identifies the worst-case molecule based on a customer-defined risk assessment process.
Increased productivity: In a manual system, highly skilled employees are forced to spend a significant amount of time shuffling paper. When you digitize your cleaning validation efforts, employees can focus on more critical tasks.
Real-time visibility: With ValGenesis, all validation deliverables are electronically created, reviewed, and approved. Eliminating paper from the validation process dramatically increases visibility and provides you with real-time validation status information.
Mobile access: Our solution allows you to access critical documents, complete pending tasks, and collect vital data using your tablet or smartphone, extending the benefits of an automated system across multiple sites, anywhere in your organization.
Improve Your Cleaning Validation Methods with these Unique Features
Many life sciences companies are beginning to realize the cost and time savings of digitizing their cleaning validation efforts with ValGenesis' feature-rich cleaning validation solution. Features include:
- Validation master plan driven by application tools such as decision trees, frameworks, templates, and dynamic trace matrices
- Electronic execution of cleaning log/batch records
- Automatic creation of process equipment train (PET) and equipment grouping
- Automatic trend analysis as part of annual product quality reports
- Automatic calculation of maximum allowable carryover (MACO), total equipment contact surface area, and residual limits for worst-case vs. non-worst-case products
- Integrated close-looped cleaning validation lifecycle management with change control
- Electronic protocol execution
- 21 CFR Part 11-compliant features like time-stamped audit trails, reporting, and electronic signature capabilities
Ready to join the digital validation revolution?
Be confident your products meet regulatory, quality, and safety standards with our 100% paperless cleaning validation solution.
"We reduced cycle time more than 50% and gained data integrity in our validation process."
"Validation-related observations dropped 90% after implementation."
"We can easily manage validation deliverables and change requests across global sites with full data integrity."