ValGenesis, An Enterprise Validation Management and Tracking System, was officially launched at the annual PDA meeting held at Chicago during April 2005


Chicago, IL   April 04 ,2005, ValGenesis was designed to fill the void in the pharmaceutical and biopharmaceutical industries for a validated inventory tracking system with a built-in e-signature capability. ValGenesis is an Enterprise Validation Management and Tracking System designed to manage the entire validation life cycle from validation document number generation to online execution while meeting compliance requirements imposed by the FDA.

ValGenesis is the first product in the industry capable of conducting Validation test script execution electronically equating to a completely paperless validation process. ValGenesis is a modular, web based database application that is fully compliant with 21 CFR Part 11. Each module in ValGenesis serves a specific function such as tracking the validation status of any GxP entity, developing validation documents in a collaborative manner, executing validation documents online, and scheduling revalidation tasks.

ValGenesis is a modular, web based database application that is fully compliant with 21 CFR Part 11. Each module in ValGenesis serves a specific function such as tracking the validation status, developing validation documents in a collaborative manner, executing validation documents, and scheduling revalidation tasks.

ValGenesis maintains a consistent validation methodology across all departments and company sites – something the FDA recommends for any multi-site rollout. ValGenesis will improve the overall efficiency of the validation process resulting in dramatic time and cost savings.