FDA 21 CFR Part 11 in Calibration Management: What Medical Device Quality Teams Must Know

For manufacturers of Class I, II, and III medical devices governed by FDA QSR (21 CFR Part 820) and ISO 13485, calibration management is held to the highest regulatory standard.

Under 21 CFR Part 11, electronic calibration records and electronic signatures are considered legally equivalent to paper records and handwritten signatures—provided the software fulfills stringent security and verification controls.

In GageFX, every change made to an asset—whether modifying a calibration interval, updating a tolerance specification, or approving a calibration certificate—is written to an append-only, tamper-proof audit ledger.

The ledger records the precise UTC timestamp, user ID, IP address, previous value, new value, and mandatory reason for change. Even system administrators cannot delete or alter historical audit entries.

Under Part 11.200, electronic signatures must employ at least two distinct identification components (e.g., user password plus MFA token). Furthermore, each signature manifestation must clearly document:

1. The printed name of the signer.

2. The date and time when the signature was executed.

3. The meaning (such as review, approval, responsibility, or authorship) associated with the signature.