StacksVerified U.S. regulatory reference

21 CFR §111.117

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
Quality control operations for equipment, instruments, and controls must include:
  1. (a)Reviewing and approving all processes for calibrating instruments and controls;
  2. (b)Periodically reviewing all records for calibration of instruments and controls;
  3. (c)Periodically reviewing all records for calibrations, inspections, and checks of automated, mechanical, or electronic equipment; and
  4. (d)Reviewing and approving controls to ensure that automated, mechanical, or electronic equipment functions in accordance with its intended use.