21 CRF Part 11 is a section of the Code of Federal Regulation (CFR) which was established by the United States FDA details the criteria for electronic records and signatures. While the 21 CFR relates to Pharmaceuticals and Medical Devices, Part 11 of the regulation is specifically concerned with electronic records and electronic signatures. The regulation permits and authenticates the wide use of electronic technology, compatible with FDA’s requirements to protect public health records. The regulation considers electronic records and signatures to be equivalent to paper records and handwritten signatures. The CFR Part 11 outlines requirement that ensures the authenticity of electronic data and provides guidance to US companies on how they can submit documentation in an electronic form and electronic signatures in alignment with FDA regulation. The CFR Part 11 Compliance encourages organizations to conduct business digitally and ensures the authenticity of electronic data and signatures.