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§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:
(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.
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.