Hach-Lange SI792(x) E HACH GLI 3700 series SI792(x) T 7MA2200 and 8398 series User Manual - Manual (Page 16)

General information
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2.2.2 FDA 21 CFR part 11 compliance (HART only)
In the directive “Title 21 Code of Federal Regulations, 21 CFR Part 11,
Electronic Records; Electronic Signatures“ the US American health
agency FDA (Food and Drug Administration) regulates the production
and processing of electronic documents for pharmaceutical
development and production. The features described in
section 2.2.2.1
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) E/T 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 105 ).
2.2.2.2 Audit trail for si792(x) E/T transmitters
The si792(x) transmitter 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.