The key to 21 CFR Part 11 Compliance
21 CFR Part 11 is a set of regulations issued by the U.S. Food and Drug Administration (FDA) that establishes the criteria under which electronic records and signatures are considered trustworthy, reliable, and equivalent to paper records. In order to sell products in the United States, companies must demonstrate that their systems meet the standards set forth in Part 11. This can be a daunting task, as the requirements are numerous and detailed.