Instruction manual

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 docu-

ments for pharmaceutical development and production. This

results in requirements for measuring devices used for corre-

sponding applications. The following features ensure that the

measuring devices of the Transmitter Cond Ind 7100e/2(X)H

Series meet the demands of FDA 21 CFR Part 11:

Electronic Signature

Access to the device functions is regulated and limited by indi-

vidually adjustable codes – “Passcodes” (for Passcode Editor

see Page 56, overview of factory settings on back of manual).

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

Every (manual) change of device settings can be automatically

documented. For that purpose, each change is marked by a

“Configuration Change Flag”, which can be interrogated and

documented via HART communication. Then the changed

device settings/parameters can also be retrieved and docu-

mented via HART communication.

70098_E_CI7100_2XH.QXD 27.07.2005 9:27 Uhr Seite 9