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The essence of validation as required by the FDA is to provide documented evidence that provides a high degree of assurance that all processes, equipment, 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.
105 College Road East
Princeton, New Jersey 08540
105 College Road East
Princeton, New Jersey 08540
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