11
Safety Information
Caution!
Never try to open the module!
If a repair should be required, return the module to our factory.
If the specifications in the instruction manual are not sufficient for assessing
the safety of operation, please contact the manufacturer to make sure that
your intended application is possible and safe.
Be sure to observe during installation:
Switch off power supply before replacing or inserting a module!
In their 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.
This results in requirements for measuring devices used for corresponding
applications. The following features ensure that the Protos 3400 modular
process analysis system meets the demands of FDA 21 CFR Part 11:
Electronic Signature
Access to the device functions is regulated and limited by individually adjust-
able codes – “Passcodes“. This prevents unauthorized modification of device
settings or manipulation of the measurement results. Appropriate use of these
passcodes makes them suitable as electronic signature.
Audit Trail Log
Every change of device settings can be automatically recorded and docu-
mented in the Audit Trail Log on the SmartMedia card. The recording can be
encrypted.
Conformity with FDA 21 CFR Part 11
