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Title 21 Part 111 → Subpart F → §111.117

Title 21 → Chapter I → Subchapter B → Part 111 → Subpart F → §111.117

Electronic Code of Federal Regulations e-CFR

Title 21 Part 111 → Subpart F → §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.