21 CFR Part 11 Software Module for QuantStudio™ 6 & 7 Systems

Catalog number: 4486400

Applied Biosystems™  Related applications: Real Time PCR (qPCR)

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This software module for the QuantStudio™ 6 Flex and QuantStudio™ 7 Flex real-time PCR systems 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 the 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
• Permit E-signature function for data verification


For Use With (Equipment): QuantStudio™ 6 Flex, QuantStudio™ 7 Flex
Software Type: Security
Product Size: 1 each


Manuals & protocols