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Applied Biosystems™ 21 CFR Part 11 Software Module for QuantStudio™ 12K Flex System

Catalog No. 4472053
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Description

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.

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

Specifications

For Use With (Equipment) QuantStudio™ 12 K Flex
Product Line QuantStudio
Product Type Software Module
For Use With (Application) Real Time PCR (qPCR)
Operating System Windows 7
License 10 Seat
Quantity 1 kit

Frequently Asked Questions (FAQs)

What type of Real-Time PCR (Sequence Detection System) information is available from Applied Biosystems?

Tutorials demonstrating introductions to Real-Time PCR, guidelines for designing real-time assays using Primer Express software, and various instrument set-ups can be found under Life Technologies University on our website. User bulletins, manuals and Product inserts, protocols can be found as downloadable pdf files on our Technical Resources page.

For Research Use Only. Not for use in diagnostic procedures.