User's Manual

5-1
S ECTION
5
ClINICAl TRIAlS
Actiware-CT (clinical trial) software is designed especially for customers who
are concerned about data security and compliance with 21 CFR Part 11. New
features have been included in the software that
 ●Restrictaccesstoonlyauthorizedusers.
 ●Embedelectronicsignaturesindatafiles.
 ●Securedatafileswithdigitalsignatures.
 ●Detectandreportunauthorizedaccess.
 ●Recordallchangestosubjectanddataproperties,aswellasanalysis
settings and results.
 ●Provideanaudittrailwindowtoviewversionsandelectronicsignatures.
Actiware-CT operates in the same manner as Actiware. Section 5 outlines
the security features in CT. Please refer to Getting Started in Section 2 for
information on using the software.
Note: Actiware-CT requires you to authenticate using your Windows or
Network username and password. Please contact your local administrator
with any issues or questions.
Note: Actiware-CT requires the Windows 2000 Professional or the
Windows XP Professional operating system.