21 CFR 111.117
§ 111.117 What quality control operations are required for equipment, instruments, and controls?
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 111.117, § 111.117 What quality control operations are required for equipment, instruments, and controls?, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/84161
- Permanent ID
ys:prov:84161@1- SHA-256
6475e592bd5d14c7ab2a392b8fb3933b4b3fa7e4df3bd257be53949bf53b58d2
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.