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.
Head of Sales: APAC | Head of Operations: India
Priya is responsible for Xybion business growth in APAC region. She brings over two decades of experience in Business Consulting and Operations Management. Her deep expertise in diversified areas, including strategic alliance and partnership management, diversity and inclusivity initiatives and employee development, will amplify Xybion’s global strategic relationships and will strengthen the company’s executive leadership in India. In her last role at Conduent, she served as Director-Marketing & Bid Management. Prior to this, Priya has worked with Infosys and Covansys (now CSC). Priya holds degrees in microbiology & health management.