Audit trail – Bio-Rad Bio-Plex Software® Upgrades and Conversions User Manual

Page 149

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Audit Trail

137

NOTE: In Secure Mode, each reading, including reruns of plate wells,
generates a new Results file that cannot be overwritten.

Figure 122. Electronic Signature required for reading Results file

You are also prompted to sign and save the Results file if you select the New
Results from Protocol command from the File menu (see page 143).

Audit Trail

Any changes made or actions performed after a Protocol or Results file has
been signed automatically generates an audit trail documenting each change/
action. If you make changes to a signed, read-only file and save it as a new
file, the audit trail is preserved in the new file (with the signature of the
previous file noted as part of the audit trail). Also, the audit trail for a Protocol
file is preserved in the Results file generated from that Protocol.

All major actions and changes are audited. Examples of auditable actions
include:

Signing a file

Changing Protocol settings (plate format, analyte selection, etc.)

Changing the standard curve regression type, variance model, etc.

Flagging outliers

Performing readings (audited in the Results file)

Minor changes that affect only the display, such as selecting different columns
in the Report Table or changing the axis transformation in the Standard Curve,
are not audited.

BioPlex_6.book Page 137 Friday, September 23, 2011 11:55 AM

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