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Before upgrading software or firmware, review the release notes and user guide for recalibration requirements. Changes may impact analytically validated workflows. Customers operating under analytically validated workflows must follow current Instructions for Use (IFU) and/or perform analytical validation according to their standard operating procedures.
Touchscreen operating software enables users to operate the instrument using an embedded touchscreen. A SAE application profile is required to enable QuantStudio 7 Pro system for user access control, audit, and e-signature (SAE).
The Security, Audit, and Electronic Signature (SAE) Admin Console is designed to assist compliance with 21 CFR Part 11 and to prevent unauthorized access to the instrument. When connected to the instrument, it enforces user access, audit and electronic signature policies based on lab’s configuration.
Building on the core functionality of DA2, DA3 offers enhanced data analysis and results review capabilities across the QuantStudio qPCR instrument family.
Key capabilities
Access options
Note: SAE support for QuantStudio 7 Pro is only available with the on-premises version of software, not with the desktop or cloud version.
How to access software
Touchscreen Instrument Operating software enables users to operate the instrument using an embedded touchscreen. The software can be run with security, audit, and e-signature (SAE) enabled. The SAE features are only available with the QuantStudio 7 Pro system.
| Touchscreen Instrument Operating software & SAE application profile | Download |
Design & Analysis software enables the user to set up runs, send plates to the instrument (applicable instruments only), open completed run files, and analyze and review data in an integrated and streamlined fashion. The software can be run with security, audit, and e-signature (SAE) enabled. The software also provides a suite of analysis modules for secondary analysis and comes with multi-language support.
| DA2 software & SAE application profile | Download |
The Security, Audit, and Electronic Signature (SAE) module is designed to assist compliance with 21 CFR Part 11 FDA guidelines on electronic records security and to prevent unauthorized access to the instrument. The SAE features are only available with the QuantStudio 7 Pro system.
| SAE Admin Console (RUO) | Download |
If you have purchased a QuantStudio 6 or 7 Pro real-time PCR system, you may download the system software above.
The software is available in a Thermo Fisher Connect folder. To download the software:
1. Click the Download button above, then sign in to thermofisher.com. Note: If you do not have a thermofisher.com account, click Create Account in the sign in screen, then follow the instructions.
2. After you sign in, the Thermo Fisher Connect folder will open. Locate the software product or documentation of interest, then click download.
仅供科研使用,不可用于诊断目的。
