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Applied Biosystems™ 21 CFR Part 11 Software Module for QuantStudio™ 6 and 7 Systems

Catalog No. 4486400
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4486400 10 licenses
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Catalog No. 4486400 Supplier Applied Biosystems™ Supplier No. 4486400
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Description

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

Specifications

For Use With (Equipment) QuantStudio™ 6 Flex, QuantStudio™ 7
Product Line QuantStudio
Software Type Security
Product Type Software Module
For Use With (Application) Real Time PCR (qPCR)
Quantity 10 licenses

Frequently Asked Questions (FAQs)

Is QuantStudio 6 and 7 Flex Real-Time PCR System Software (v1.7.2 and v1.3) compatible with Windows 11?

The compatibility of QuantStudio 6 and 7 Flex Real-Time PCR System Software (v1.7.2 and v1.3) has not been tested with Windows 11 and cannot be guaranteed to work in Windows 11.

Can I import a standard curve for my real-time PCR data into the Design & Analysis Software (v2.x)?

It is possible to import a standard curve into the Design & Analysis Software (v2.x) if you are analyzing results from one of the following Applied Biosystems real-time PCR instruments:
• 7900HT Fast Real-Time PCR System
• 7500/7500 Fast Real-Time PCR System
• StepOne/StepOne Plus Real-Time PCR System
• ViiA 7 Real Time PCR System
• QuantStudio 1 Real-Time PCR System
• QuantStudio 3 & 5 Real-Time PCR System
• QuantStudio 6 & 7 Flex Real-Time PCR System
• QuantStudio 6 & 7 Pro Real-Time PCR Systems
• QuantStudio 12K Flex Real-Time PCR system

Follow the instructions below to import a standard curve for analysis in the Design & Analysis Software (v2.x):
1. Open the data file in the Design & Analysis Software (v2.x).
2. Click on Actions.
3. Click on "Standard Curve Analysis Setting".
4. Select "External Standard Curves" and click on "Import".
5. Browse to the proper .csv file and click "Open".
6. Click "Apply".

What is the last software version for the ViiA7 Software?

ViiA7 Software v1.2.4 was the last version of the ViiA7 Software released. Currently, the ViiA7 Real-Time PCR System can be controlled using the QuantStudio Software. To obtain the most recent copy of the QuantStudio Software for performing experiments on the ViiA7 Real-Time PCR System, please visit the instrument software download page, https://www.thermofisher.com/us/en/home/technical-resources/software-downloads/applied-biosystems-viia-7-real-time-pcr-system.html.