Roche Cobas 4800 System - Page 82

4
Software
Database
cobas® 4800 System
Systeni
Manual
• Configuration changes, inciuding changes in user accounts
• Interactions with LIS
• Audit trail changes (e.g. ifan audit trail was
exported)
The audit trail of the software is designed based
on guidelines in FDA Title 21 CFR,
Part 11, Electronic Records: Electronic Signatures.
To access the audit trail, choose Messages
> Audit trail.
OVr3W Workp!22e Reufts Utlidies
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Roche Diagnostics
A List of
user activities
B Information area
Figure 4-14 Audittrail
C Changes area
You can
export the audit trail as a CSV file by selecting one or more
entries and
choosing the
Export button.
B -
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11.23,2013122012
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$10
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82
System Manual . Version 1.0