US FDA
21 CFR 211.68 - Automatic, Mechanical and Electronic Equipment
Plain-language explanation, inspection context and common violation patterns.
What it says
Automatic, mechanical or electronic equipment, including computers, used in manufacturing or quality control must be routinely calibrated, inspected or checked according to a written programme designed to assure proper performance, with records of these checks maintained.
Paraphrased for plain-language clarity. Always verify against the current published regulation text.
What it means in practice
- This provision requires an ongoing, written, scheduled programme, not simply calibration at the time of installation with no continuing verification.
- It explicitly extends to computerised systems, which is the regulatory anchor for computer system validation and data integrity expectations around automated equipment.
- A calibration programme must define the interval, method and acceptance criteria in advance, so that a result outside expectation is recognisable as such rather than only discovered informally.
What FDA inspectors look for
- Whether calibration and checking intervals are actually followed as scheduled, with gaps or overdue calibrations investigated and documented.
- Whether equipment used during a period when its calibration was overdue or out of tolerance was assessed for impact on the data or product it touched during that period.
- Whether computerised systems specifically have documented validation status alongside their calibration and maintenance records.
Most common violation
Calibration intervals exceeded without documented justification or impact assessment, and equipment used in production or testing during a period when its calibration status was not current.
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