Cleaning Validation Software That Accelerates GMP Compliance
Meet regulatory requirements and validate process equipment faster.
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End-to-end cleaning validation management: ValGenesis cleaning validation software automates the entire cleaning validation lifecycle by integrating all stages of cleaning validation, from design and development to validation to continuous monitoring. It replicates your current cleaning validation process while replacing the human error and inefficiency implicit in paper-based methods with improved consistency and reliability. There is no need to reconfigure your existing approach to reap the benefits of digitization.
Consistent outputs: Our VLMS automates key stage one activities, including analytical method development and the creation of the cleaning validation master plan, with technical controls, offering you a consistent way to perform cleaning validation lifecycle activities. You can create business rules based on your SOPs and requirements to ensure consistent output, including product family, equipment grouping, dirty and clean hold times, product assessment, and more.
Increased regulatory compliance: Our automated cleaning validation solution dynamically creates the process equipment train (PET) and equipment grouping using the product, equipment, and manufacturing master data creating a complete audit trail that complies with regulatory requirements. Information that is mandatory for international regulatory bodies will be denoted as compulsory in the system, and you can configure additional data entry fields based on your specific needs.
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.
Streamlined cleanability impact assessments: Digitizing with ValGenesis allows you to perform the cleanability impact assessment through a one-time framework setup that automatically walks you through every required consideration. Streamlining this process saves you time and lets you know what to do to make, approve, and implement the change.
Rooted in scientific evidence: One of the biggest pain points in cleaning validation is ensuring that your methods and procedures are rooted in scientific evidence. Limit of detection (LOD) and limit of quantitation (LOQ) values are fully integrated into our cleaning validation software. The system flags out-of-limit values as not analytically supported.