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.
Head of Quality Assurance
Heidi leads Xybion’s Quality Assurance practice. She has over 20 years’ experience in designing and implementing quality assurance policies. Since joining Xybion in 2000, Heidi worked with several clients to design quality policies and ensure compliance. She is responsible to hosting Xybion customer audits. Heidi has a BA degree in Biology from The King’s College.