Cleaning Validation Software That Accelerates GMP Compliance
Meet regulatory requirements and validate process equipment faster.
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.