Intended Use; Conformity With Fda 21 Cfr Part 11 - Burkert 8285 El. COND Mode D'emploi

Intended use

The module is an input module for conductivity measurement with
commercially available 2- or 4-electrode sensors.

Conformity with FDA 21 CFR Part 11

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 Series 8285 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 adju-
stable 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
encoded.
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