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FDA 21 CFR Part 11
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 American health agency
FDA (Food and Drug Administration) regulates the production and
processing of electronic documents for pharmaceutical develop-
ment and production. This results in requirements for measuring
devices used for corresponding applications. The following features
ensure that the measuring devices of this Series meet the demands of
FDA 21 CFR Part 11:
Electronic Signature – Passcodes
Access to the device functions is regulated and limited by individually
adjustable codes – “Passcodes“ (see SERVICE). This prevents unauthor-
ized modification of device settings or manipulation of the measure-
ment results. Appropriate use of these passcodes makes them suitable
as electronic signature.
Audit Trail
Every (manual) change of device settings can be automatically docu-
mented. Each change is tagged with a “Configuration Change Flag“,
which can be interrogated and documented using HART communica-
tion. Altered device settings or parameters can also be retrieved and
documented using HART communication.
Extended logbook (TAN SW-A003)
Audit Trail also records function activations (CAL, CONFIG, SERVICE),
some Sensoface messages (cal timer, wear, SIP, CIP) and opening of the
enclosure.
Summary of Contents for Stratos Pro A201 PH
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