The core essence of Validation as required by the FDA is to provide documented evidence that provides a high degree of assurance that all processes, equipments, instruments, facilities, software and materials used will consistently produce a product meeting its pre-determined specifications and quality attributes. This requires establishing and updating protocols and procedures to be always consistent with the current regulations.

Xybion’s Validation Management software allows companies to create a unified process for creating, managing, and executing all validation activities across multiple sites and multiple countries and multiple regulatory guidelines as necessary.