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Applied Biosystems™ 21 CFR Part 11 Software Module for QuantStudio™ 6 and 7 Systems
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.
Supplier: Applied Biosystems™ 4486400
Description
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
Spécifications
| QuantStudio™ 6 Flex, QuantStudio™ 7 | |
| Security | |
| Real Time PCR (qPCR) |
| QuantStudio | |
| Software Module | |
| 10 licenses |