What is gxp and sox?

A system is considered to be in-scope for SOx if its functionality supports the operation of key business financial processes and controls. GxP is a collection of quality guidelines and regulations created to ensure that bio/pharmaceutical products are safe, meet their intended use, and adhere to quality processes during manufacturing, control, storage, and distribution. In 2002, the United States Congress passed the Sarbanes-Oxley Act (SOX) to protect shareholders and the general public from accounting. GxP is a general abbreviation for the "good practice" quality guidelines and regulations. GxP requirements are intended to ensure that food and medical products are safe for consumers. IT compliance within pharma organizations has traditionally been viewed through discrete regulatory lenses such as SOX and GxP Quality.