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Applied Biosystems™ 21 CFR Part 11 Software Module for ViiA™ 7 System
Description
This software module supports compliance with 21CFR Part 11 FDA guidelines on electronic records security and prevents unauthorized access to your ViiA7 instruments. When loaded on the instrument, this software will:
• Authenticate each user’s log-in information
• Lock out access and requite re-authentication if user is inactive for a set period of time
• Log any unauthorized attempts to access ViiA7 System software in the Event Log
• Verify each user’s permission to perform predefined Controlled Activities.
• Permits E-signature function for data verification.
Specifications
Specifications
| Content And Storage | One Software CD. |
| For Use With (Equipment) | ViiA™ 7 System |
| Product Line | ViiA |
| Software Type | Instrument Access and Security |
| Product Type | Software Module |
| For Use With (Application) | Real Time PCR (qPCR) |
| Operating System | Windows |
| Quantity | 1 software |
Frequently Asked Questions (FAQs)
To open the software download on your Mac, you will need to adjust your security settings using the following instructions from Apple support:
Safely open apps on your mac
Please note, the software should run on Mac OS 10.10 or later.
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".
If you are analyzing results from the ViiA 7 Real-Time PCR System, QuantStudio 6 Flex Real-Time PCR System, or QuantStudio 7 Flex Real-Time PCR System, it is possible to import a standard curve into the QuantStudio Real-Time PCR Software following the instructions below:
1. Open the data file in the QuantStudio Real-Time PCR Software.
2. Go to Analysis Settings.
3. Click on the "Standard Curve Settings" tab.
4. Select the option to "Use a standard curve imported from another experiment" and click on "Import".
5. Browse to and highlight the proper data file and click "Select".
6. Click Apply Analysis Settings.
No, you do not need to back up the calibration files as all of the calibration files are stored on the ViiA7 Real-Time PCR instrument. Once the computer software is properly installed and the computer is connected to the instrument, the calibration information will automatically update in the QuantStudio Software.
Yes, you can still start a run on the ViiA7 Real-Time PCR System if the expired calibration notice displays. This is just a reminder and you can close it to proceed with the run. Additionally, you can change when you want the notifications to show up and how frequently you want to be notified to calibrate the instrument. To do this, go to the toolbar in the QuantStudio Software and select Instrument > Instrument Console. Select your instrument icon and click on Manager Instrument > Maintenance > Calibration Reminders. From the Calibration reminders Settings page you can update when the calibrations expire, turn expiration reminders on/off, and set when the reminders show up.
For Research Use Only. Not for use in diagnostic procedures.