Universal Tensile Testing Machines (UTMs)

Universal Tensile Testing Machines (UTMs)

Universal Tensile Testing Machines (UTMs) are prominent instruments at Smithers and are used to perform a wide range of mechanical tests on medical devices. 

Within Smithers Medical Device Physical and Functional Testing department the UTMs perform cGMP testing with software that meets the requirements of FDA 21 CFR Part 11 featuring three main components; revision history, electronic signatures, and an audit trail. 

21 CFR Part 11 is a regulatory framework designed by the US Food and Drug Administration (FDA) providing guidance on creating, managing, and maintaining electronic records and electronic signatures. Compliance to cGMP involves the implementation of principles and guidelines, which ensure that medicinal products and devices are consistently produced and controlled to suit their intended use. 

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