Thermo Fisher, A49208, iBright™ SAE Software for 21 CFR Part 11, single license

Quantity: 1 license
Unit Size: Each
• Authentication of user login information
• Ability to set password guidelines and expiry dates
• Lockout access and re-authentication requirements after a period of inactivity
• System lockout upon unauthorized attempts to access software
• Ability of administrator to define user roles and permissions
• Verification of each user's permissions to perform predefined activities
• Identification of data tampering
• Generation of audit trail log
• Tracking of changes and committed actions to user roles, account management, and system settings
• Ability of administrator to determine functions required to input reason for commit
• Administrator determination of e-signature requirements
• Ability to review records and sign electronically