21 CFR 58: what it asks of a calibration register

21 CFR 58.63 requires equipment used to generate data to be tested, calibrated and standardized according to written standard operating procedures, with records kept.

Findings that cite it

Finding	Clause
1. Overdue: the due date worked out is earlier than the as-at date	21 CFR 58.63
4. Out of tolerance as found, with no impact assessment recorded	21 CFR 58.63
8. Calibrated in house with no procedure named	21 CFR 58.63

21 CFR 58: every clause cited

1 of the 25 held

The requirement text is our statement of each clause, read against the copy we hold and cited to it; it is not the standard verbatim.

21 CFR 58.63Maintenance and Calibration of Equipment

Equipment must be adequately inspected, cleaned, and maintained. Equipment used for data generation must be tested, calibrated, and standardized according to written SOPs.

What a certification body auditor asks to see: Calibration SOPs; Calibration records; PM schedules; Out-of-tolerance investigations

Where registers usually fall short: Out-of-tolerance impact assessment missing; PM not scheduled; Calibration standards not traceable to NIST

Source: 21 CFR Part 58, good laboratory practice for nonclinical laboratory studies