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Quality     |     Our Equipment  :  Our Certifications  :  Our Validations

Onyx embraces a comprehensive Validation Strategy which includes:

    • Equipment (IQ, OQe),
    • Software (CSV),
    • Measuring Instruments (MIV), and
    • Processes (OQp, PQ). 

These components are integrated to achieve fully validated systems as required in Onyx's documented Master Validation Plan. 

Aside from being an industry and regulatory requirement, we firmly believe that, when executed properly, this is simply good business practice. Appropriately validated systems will sustainably yield the most compliant outcomes by ensuring full implementation of all QMS and regulatory requirements, including management of and provision for re-validation. Onyx procedures and protocols have been developed with over a decade of input from best practices around the world. Our Validations represent a collaborative initiative between Quality and Manufacturing and are explicitly designed to address Onyx processes while incorporating customer specific requirements, such that validations will be universally accepted.

We know that we can count on Onyx to provide product and process expertise to a project. Thanks again for your recommendations on controlling costs. That is exactly what we are looking for in a supplier.

— G.W., Purchasing Manager, Top 3 Orthopedic Company