---
kind: "section"
citation: "21 C.F.R. § 111.117"
title: "21"
number: "111.117"
heading: "What quality control operations are required for equipment, instruments, and controls?"
url: "https://uscodex.org/cfr/21/111.117"
---

# §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.

## Notes

### 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.