Regulations last checked for updates: Dec 17, 2025

Title 21 - Food and Drugs last revised: Dec 11, 2025
§ 111.117 - What quality control operations are required for equipment, instruments, and controls?

Quality control operations for equipment, instruments, and controls must include:

(a) Reviewing and approving all processes for calibrating instruments and controls;

(b) Periodically reviewing all records for calibration of instruments and controls;

(c) Periodically reviewing all records for calibrations, inspections, and checks of automated, mechanical, or electronic equipment; and

(d) Reviewing and approving controls to ensure that automated, mechanical, or electronic equipment functions in accordance with its intended use.

source: 72 FR 34942, June 25, 2007, unless otherwise noted.
cite as: 21 CFR 111.117