Software Manual Freedom EVOware Standard 2.3 Freedom ...

B - Appendix B - FDA 21 CFR Part 11 Compliance
Freedom EVOware Installation Checklist
B.9.1 Before Installing Freedom EVOware
Designate an experienced system administrator to set up the PC and the PC
network.
The system administrator must develop a secure and effective way of
remembering his or her password.
If you plan to install Freedom EVOware in a network environment (LAN), take
appropriate configuration steps when installing the Microsoft operating system
and the network server(s).
If you plan to store Freedom EVOware data on a network, you must assign
appropriate access privileges to the network directories.
Archive and clear existing Microsoft Application, Security and System logs.
For network domain servers, disable the Guest account.
For network domain users, set the same account policies as on the local PCs:
• Set the “Enforce password history” password policy to “12 passwords
remembered”.
• Set the “Maximum password age” password policy to 30 days.
• Set the “Minimum password age” password policy to 5 days.
• Set the “Minimum password length” password policy to 5 characters.
• Set the “Account lockout threshold” account lockout policy to 3 invalid logon
attempts.
Activate password-protected screen savers.
B.9.2 Installing Freedom EVOware
Install the Freedom EVOware software according to the installation instructions
supplied with the software. In some countries, the Freedom EVOware software
must be installed by an authorized Tecan Field Service Engineer. Contact your
local Tecan distributor for more information.
B.9.3 After Installing Freedom EVOware
Ensure that the Microsoft Application, Security and System logs are set to “Do not
overwrite events (clear log manually)”.
Increase the default size for the Microsoft Application, Security and System logs.
Ensure that the following procedures are implemented to address sections of the
21 CFR Part 11 regulations, including (but not necessarily limited to):
• Provide suitable education, training and practical experience to personnel.
• Ensure that individuals are held accountable and responsible for their actions
when using the pipetting system and the Freedom EVOware software.
• Verify the identity of each individual who is permitted to work with Freedom
EVOware.
• Create separate Freedom EVOware user accounts using the Tecan User
Management system for all persons who are authorized to use Freedom
EVOware.
• Create separate PC and/or PC network user accounts using standard
Microsoft tools and procedures for all persons who are authorized to use
Freedom EVOware.
• Implement appropriate controls over distribution, use of and access to data
and log files.
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