This software module supports compliance with 21CFR Part 11 FDA guidelines on electronic records security and prevents unauthorized access to your ViiA7 instruments. When loaded on the instrument, this software will:
• Authenticate each user’s log-in information
• Lock out access and requite re-authentication if user is inactive for a set period of time
• Log any unauthorized attempts to access ViiA7 System software in the Event Log
• Verify each user’s permission to perform predefined Controlled Activities.
• Permits E-signature function for data verification.