Software Manual Freedom EVOware Standard 2.3 Freedom ...

B - Appendix B - FDA 21 CFR Part 11 Compliance
Security Features in the Software Which Assist 21 CFR Part 11 Compliance
This mechanism provides both the ability to carry out authority checks and the
ability to sign and/or authorize electronic records. Each user is traceable and
accountable for his or her actions, process data and configuration changes.
To maximize security, the Freedom EVOware access control mechanisms are
independent of the access control mechanisms in the Microsoft operating system.
Accordingly, user accounts and passwords for the operating system and for the
Freedom EVOware system are managed separately. Freedom EVOware user
accounts are managed with the Tecan User Management system. User accounts
for the Microsoft operating system are managed using standard Microsoft tools
and procedures.
B.5.2 Freedom EVOware User Levels
There are four user levels in Freedom EVOware:
Operator, Power User, Application Specialist and Administrator.
Operator has rights to:
• Run a pipetting script (Freedom EVOware Standard)
or process (Freedom EVOware Plus)
• Run maintenance scripts (see 6.4.2 “Run Maintenance”, 6-10)
• View a pipetting script (but not change it)
• Handle errors during pipetting
Power User: Same rights as Operator but with additional rights to:
• Start running pipetting scripts at a specified line number.
• Run direct commands (see 5.4.1.3 “Direct commands”, 5-10)
Application Specialist: Same rights as Operator but with additional rights to:
• Create, modify and save pipetting scripts (Freedom EVOware Standard and
Freedom EVOware Plus) and processes (Freedom EVOware Plus)
• Edit the configuration of the pipetting instrument
• Edit the configurations of carriers and labware
• Edit the liquid classes for pipetting
• Change settings in the Freedom EVOware Configuration Tool
• Skip pre-programmed timers during pipetting,
Administrator: Same rights as Application Specialist but with additional rights to:
• Create and disable/re-enable users
• Configure the options in the Tecan User Management system
• Enable or disable the Electronic Signatures feature
B.5.3 Tecan User Management System
The Tecan User Management system, which is used by Freedom EVOware and
other Tecan software components, has the following main features:
• All changes relating to user management require Freedom EVOware
Administrator access rights.
• All changes relating to user management are recorded in the user
management audit trail.
• User accounts are automatically disabled following a configurable number of
consecutive failed attempts to enter the correct user name and password
combination. The disabled account can only be reactivated again by the
Freedom EVOware Administrator.
Freedom EVOware Software Manual, 393172, en, V2.3 B - 7