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
• Date and time of creation or modification
• User name
• User-specified reason for the change (if the Electronic Signatures feature is
enabled in the Freedom EVOware Configuration Tool) See B.5.5 “Electronic
Signatures”, B-9.
• User’s full name
A warning is shown if an attempt is made to load a file with an incorrect or missing
checksum. The user can then choose to load the file or cancel. In the latter case,
Freedom EVOware aborts with the exception of script files. In this case, the file is
not loaded but Freedom EVOware remains running. An entry is written to the log
file each time an incorrect or missing checksum is found.
Note: A user with Freedom EVOware Administrator rights can enable or disable
the incorrect checksum warning using the Freedom EVOware Configuration Tool
(see 8.3.1.4 “Protocol Options Tab”, 8-8). To comply with the FDA regulations,
this feature must not be disabled.
B.5.5 Electronic Signatures
The Freedom EVOware security features ensure that the currently logged in user
can be uniquely identified. Furthermore, Freedom EVOware users should be
instructed never to leave the running system unattended without first logging out.
To ensure full compliance with 21 CFR Part 11, the Freedom EVOware
Administrator must also activate Freedom EVOware’s Electronic Signatures
feature, which provides support for a series of signings in one session.
The Electronic Signatures feature records user input on the reason for creating or
changing configuration files, data files and user management settings. It helps to
identify why the user performed a specific action.
Note: A user with Freedom EVOware Administrator rights can enable or disable
the electronic signatures feature using the Freedom EVOware Configuration Tool
(see 8.3.1.4 “Protocol Options Tab”, 8-8). To comply with the FDA regulations,
this feature must not be disabled.
If the Electronic Signatures feature is activated, a dialog box is shown when
carrying out one of the following actions:
• Creating, deleting or editing script files and script templates
• Creating, deleting or editing process files and process templates
• Creating, deleting or editing worktable templates
• Creating, deleting or editing carrier definitions
• Creating, deleting or editing labware definitions
• Creating, deleting or editing liquid classes
• Making changes to configuration settings
• Creating, deleting or editing users, groups and password rules
The currently logged in user must re-enter his or her password and specify the
reason for the change:
Freedom EVOware Software Manual, 393172, en, V2.3 B - 9