What is FDA 21 CFR Part 11?
FDA 21 CFR Part 11 regulation (Part 11) is the Food and Drug Administration's regulations that cover document signing and records retention for processes and documents specified by the FDA. Prescribed as an “open system” system solution, as defined in Section 11.3(b)(9), in which there is electronic communication among multiple persons and where system access extends to people who are not part of the organization that operates the system. The controls for an open system are discussed in Section 11.30.