Beckman Coulter FP 1000, Руководство пользователя, Страница: 40 / 52

PN 623112BA
B-2
21 CFR PART 11 REGULATION SUPPORT TOOLS
AUDIT TRAILS
PanelDef and System Software
The administrator for the FP 1000 controls user access to PanelDef and/or System software.
Any logged-on user can lock the FP 1000 System screen.
Windows 2000
The system administrator should use the security and access features provided by
Windows 2000.
Do not delete external order files through Windows.
Third-Party Software Applications
If you use a third-party software application, such as MS Excel or Adobe
®
Acrobat
®
, you must
have procedures that ensure the security of these electronic records and provide an audit trail.
Security software applications may be purchased to provide security when using third-party
software applications.
B.3 AUDIT TRAILS
Both Panel Definition and FP 1000 System software applications provide audit trails of user
log-on and log-out activities. The System software audit trail also documents various other
activities. These audit trails can be searched, displayed, and printed.
Note: If you use a third-party software application, such as MS Excel or Adobe Acrobat, you
must have procedures that ensure the security of these electronic records and provide an
audit trail. Security software applications may be purchased to provide security when using
third-party software applications.
B.4 ELECTRONIC SIGNATURES
FP 1000 software does not provide this capability. Follow your laboratory procedures for
signature approval for compliance.
Note: If you use a third-party software application, such as MS Excel or Adobe Acrobat, you
must have procedures that ensure the security of these electronic records and provide an
audit trail. Security software applications may be purchased to provide security when using
third-party software applications.