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The audit trail log cannot be queried by the Protos. It can only be evaluated
using the suitable PC program. According to FDA 21 CFR Part 11 the user must
ensure the transport of the data from the PROTOS to evaluation and further
processing or archiving. Furthermore, the user must ensure that the log data
cannot be deleted from the memory card. The PC evaluation program is able
to decrypt the data and verify the security parameters and thus to prove the
authenticity of the data on the card. It allows printing the encrypted data and
exporting them to other PC applications.
Logbook
The logbook is provided in addition. In AuditTrail systems it runs simultaneous-
ly with the audit trail log in contrast to which it can be queried provided that
the diagnostics menu is accessible. The administrator is permitted to delete the
logbook data since all security-relevant data are stored in the AuditTrail log.
Recordings in the AuditTrail log
Caution!
Data loss (even total destruction) might occur if the card is not closed
before it is pulled out (Maintenance menu, “Close memory card”).
The following entries and messages are recorded:
• Measuring point, device description, module equipment and serial numbers
• Menu system log-ins
• Movements within menus (menu headlines)
• Modified parameters at the press of enter
• Calibration record at the end of a calibration or adjustment incl. user name,
sensor type and serial number
• Messages such as failure and maintenance request
AuditTrail Log
Parameter
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