Hach-Lange SI792 C, SI792x C, SI792x C-FF, SI792x C-PA User Manual - Manual (Page 16)

General information
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and section 2.2.2.2 make the transmitter compliant with the
requirements of FDA 21 CFR Part 11.
2.2.2.1 Electronic signatures for si792(x) C transmitters
Device functions are protected by passcode access, which prevents
unauthorized modification of device settings or manipulation of
measurement results. Passcodes may be used as electronic
signatures. Passcodes can be edited with the passcode editor
(
Appendix C on page 97 ).
2.2.2.2 Audit trail for si792(x) C transmitters
The si792(x) can automatically track all changes to the device settings.
Each change is tagged with a Configuration Change flag, which is
documented using HART communication. Altered device settings or
parameters can be retrieved from the transmitter using HART
communication.