21 C.F.R. § 111.117

Current through May 31, 2024
Section 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.

21 C.F.R. § 111.117