General information
14
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
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
(
).
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.
Summary of Contents for si792 T
Page 2: ......
Page 12: ...Specifications 10...
Page 32: ...Installation 30...
Page 36: ...Interface and navigation 34...
Page 66: ...Operation Foundation Fieldbus 64...
Page 80: ...Maintenance 78...
Page 86: ...Troubleshooting 84...
Page 88: ...Replacement parts 86...
Page 94: ...Warranty liability and complaints 92...
Page 98: ...Calibration solutions 96...
Page 106: ...Concentration curves 104...
Page 112: ...ATEX safety instructions 110 Figure 20 Sanitary style sensor...
Page 116: ...Index 114...