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Protos 3400(X)
AuditTrail
Function description
Electronic data recording and backup according to FDA 21 CFR Part 11
Pharmaceutical applications not only require a hygienic design, but also the
protection and complete recording of data (FDA regulation: 21 CFR Part 11).
The PROTOS with stainless steel enclosure and SmartMedia card meets these
demands. The FDA regulation basically consists of two parts: “Audit Trail” and
“Electronic Signature”. For every change of parameters, the device records what
has been changed and who has changed it.
Functions like calibration (adjustment) often may only be performed after
written approval! This approval is given by an electronic signature.
AuditTrail card
The AuditTrail card is a specially prepared SmartMedia card. The Protos records
the audit trail log on an audit trail card only. Readability from PC is not affected.
Note:
Only specially coded SmartMedia cards supplied from Knick can be used as
AuditTrail cards.
As delivered, the AuditTrail card includes a PC program which makes the
recorded AuditTrail data readable. When log encryption has been activated,
it also allows decrypting of the data. The program supports the data export to
other programs, e.g. Microsoft Excel.
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