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
Fig. B-1
Password prompt with the Electronic Signatures feature active
After confirming the entries by clicking OK, an electronic signature is executed
and an entry is made in Freedom EVOware’s trace file.
The Data Explorer can be used to view the user comment for each of these files
(see A.9.1 “Data Explorer Tool”, A-35). Only the most recent comment is saved
in the file. Earlier comments are stored with previous versions of these files, which
are automatically backed up to the \AuditTrail\Configuration
directory (see A.5 “Freedom EVOware Directory Structure and Files”, A-25).
The plain text header of each file can also be viewed independently of Freedom
EVOware using a suitable editor. The following information is stored in the header:
• CRC checksum
• 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)
• User’s full name
A user comment is required by 21 CFR Part 58 (GLP) but not by 21 CFR Part 11,
although some customers want to record this type of information anyway.
If one of the above changes has been made automatically by Freedom EVOware,
a comment is inserted which starts with “EVOware:”
B.5.6 Trace File (Audit Trail)
The trace file contains information on configuration, data and log files which have
been created, edited or saved. The default location for the trace file is
\AuditTrail\Log.
Each time a configuration, data or log file is created or modified, a CRC checksum
is stored in the file and an entry is made in the trace file.
Each entry in the trace file specifies the date and time, the name of the currently
logged in user and the file name. Log files are created by Freedom EVOware
automatically and a user name is not included in the trace file entry in this case.
The trace file can be viewed with a plain text editor.
Each time a configuration or data file is modified and saved, the previous version
is archived in the \AuditTrail\Configuration sub-directory. The date
and time is appended to the original filename. The archive copy includes the userspecified
reason for the change if “Electronic Signatures” is enabled in the
Freedom EVOware Configuration Tool (see B.5.5 “Electronic Signatures”, B-9).
B - 10 Freedom EVOware Software Manual, 393172, en, V2.3