What quality control operations are required for equipment, instruments, and controls?
21 C.F.R. § 111.117
in effectEffective: 2024-07-01Quality 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: eCFRURL: https://www.ecfr.gov/api/versioner/v1/full/2024-07-01/title-21.xmlFetched: 7/26/2026