Sign Off on Calibration Records
— Electronically and Defensibly.
In FDA-regulated and medical-device environments, a record isn't complete until it's signed by the right person. GageList applies true electronic signatures to your calibration records — built to support 21 CFR Part 11 and to align with the FDA QMSR (which incorporates ISO 13485:2016).
A wet-ink signature on a printout isn't a controlled record.
Paper sign-offs get lost, photocopied, and questioned in audits. If you're subject to FDA or ISO 13485, you need signatures that are tied to a verified user, time-stamped, and locked to the record they approve.
GageList builds that into the calibration workflow, so sign-off is part of the record — not a piece of paper stapled to it.
True Electronic Signatures
Each signature is attributed to a verified user and time-stamped, satisfying 21 CFR Part 11 expectations for electronic signatures.
Built Into the Record
Signatures attach to the calibration record itself and become part of its permanent, traceable history — not a separate document.
Made for Regulated Quality
Supports 21 CFR Part 11 and aligns with the FDA QMSR (21 CFR 820, harmonized with ISO 13485:2016) for FDA and medical-device programs.
How You Win
Defensible sign-off.
Every approval is attributed, time-stamped, and locked to its record.
Less paper, less risk.
No binders of printouts to manage, lose, or reconstruct at audit time.
Audit-ready by design.
Signatures live in the same traceable history as the calibration data.
What This Looks Like in Practice
A medical-device manufacturer signs every calibration record electronically in GageList for its 21 CFR Part 11 program.
Frequently Asked Questions
Does GageList support 21 CFR Part 11 electronic signatures?
Yes. GageList provides true electronic signatures attributed to a verified user and time-stamped, supporting 21 CFR Part 11 requirements. For the full regulatory breakdown, see our 21 CFR Part 11 & QMSR compliance page. (Your validated procedures, access controls, and SOPs determine actual compliance — the software supports it.)
What standards do GageList digital signatures support?
They support FDA 21 CFR Part 11 and align with the FDA QMSR — the Quality Management System Regulation that, since 2 February 2026, restructures 21 CFR 820 to incorporate ISO 13485:2016. These are the requirements common to FDA-regulated and medical-device quality programs.
Are the signatures tied to the calibration record?
Yes. A signature attaches to the specific record it approves and becomes part of that record's permanent, traceable history.
Who can sign a record?
Signing is tied to verified users, and role-based access controls who is permitted to approve records. See the Security & Trust page for access controls.
Is this different from a scanned wet-ink signature?
Yes. A scanned signature is just an image. A GageList electronic signature is attributed, time-stamped, and locked to the record, which is what regulated environments require.
See it live
Get a guided walkthrough with our team and your questions answered in about 20 minutes.