Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations (CFR) that establishes the FDA regulations on electronic records and electronic signatures (ERES). Part 11 is a law that ensures that companies implement good business practices by defining the criteria under which electronic records and signatures are considered to be accurate, authentic, trustworthy, reliable, confidential, and equivalent to paper records and handwritten signatures on paper. The goal of the Part 11 audits is to ensure life sciences companies are implementing the required controls to ensure the safety of users of their products. GxP refers to “good working practices” about various areas of the life sciences industry. They include manufacturing, laboratory, clinical, etc. The audits are conducted against these practices to ensure compliance.