This software module for the QuantStudio™ 12K Flex Real-Time PCR System supports compliance with 21 CFR Part 11 FDA guidelines on electronic records security and prevents unauthorized access to the instrument. When loaded on the system, this software will:

• Authenticate each user’s log-in information
• Lock out access and require re-authentication if user is inactive for a set period of time
• Log any unauthorized attempts to access the system software in the Event Log
• Verify each user’s permission to perform predefined Controlled Activities
• Permits E-signature function for data verification