§111.117. What quality control operations are required for equipment, instruments, and controls?
21 C.F.R. § 111.117
Quality control operations for equipment, instruments, and controls must include:
Reviewing and approving all processes for calibrating instruments and controls;
Periodically reviewing all records for calibration of instruments and controls;
Periodically reviewing all records for calibrations, inspections, and checks of automated, mechanical, or electronic equipment; and
Reviewing and approving controls to ensure that automated, mechanical, or electronic equipment functions in accordance with its intended use.
Notes, amendments, and revision history
Authority
Authority: 21 U.S.C. 321, 342, 343, 371, 374, 381, 393; 42 U.S.C. 264.
Source
Source: 72 FR 34942, June 25, 2007, unless otherwise noted.