In the United States (US), GxP regulations are enforced by the FDA and are contained in Title 21 of the Code of Federal Regulations (21 CFR).
Within 21 CFR, Part 11 contains the requirements for computer systems that create, modify, maintain, archive, retrieve, or distribute electronic records and electronic signatures in support of GxP-regulated activities. Part 11 was created to permit the adoption of new information technologies by FDA-regulated life sciences organizations, while simultaneously providing a framework to ensure that the electronic GxP data is trustworthy and reliable.