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
• Freedom EVOware does not allow more than one person to use the software
simultaneously.
• Users can log out without leaving Freedom EVOware or interrupting a running
pipetting script or process. The same or a different user can then log in to
Freedom EVOware again while the script or process is still running. See
6.1.9 “Lock EVOware”, 6-7.
• Users are automatically logged out after a specified time during which no
keyboard or mouse-click activities have been detected.
• User passwords expire after a configurable number of days. The user must
then choose another password. The new password must be different from the
old password.
• Passwords must contain a specified minimum number of characters.
• Passwords can be forced to contain numeric digits.
• Passwords cannot be reused.
• User names and user name and password combinations are unique within the
system and cannot be assigned more than once.
• The Freedom EVOware Administrator provides a temporary password when
setting up a user. When the new user first logs on to the system, he or she is
forced to change the password immediately. This ensures that no one other
than the individual user knows the particular user name and password
combination.
• If a user forgets his/her password, the Freedom EVOware Administrator does
not have access to the user’s password. The Freedom EVOware
Administrator is only able to reset the password and provide a new temporary
password.
• If the Freedom EVOware Administrator forgets his or her password, no one
has access to the password.
• A specified person (typically the Freedom EVOware Administrator) can be
automatically notified by eMail in case of potential security threats (e.g. a user
account has been disabled after a configurable number of consecutive failed
login attempts).
B.5.3.1 User Management Audit Trail
All changes relating to user management are recorded in the user management
audit trail. A new file is written to the \AuditTrail\Configuration
directory each time you start and then exit the Freedom EVOware Configuration
Tool. The file name is UserTrailYYYYMMDD_HHMMSS, where YYYYMMDD is
the file creation date and HHMMSS is the file creation time.
B.5.4 Checksums
Freedom EVOware uses a checksum system which is based on a CRC algorithm
to protect configuration, script, trace and log files. The checksum is a computed
value which is used to detect corrupted or otherwise altered data. It is also able to
detect whether files have been modified outside of Freedom EVOware by another
program or process. The checksum is stored in the file header.
The Data Explorer can be used to check whether Freedom EVOware
configuration and data files have valid checksums (see A.9.1 “Data Explorer Tool”,
A-35).
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
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