Phoretix 1D 21 CFR - Compliant Image Analysis
Phoretix 1D 21 CFR for Customers requiring 21 CFR Part 11, EU Annex 11 or general GxP compliance
Combine all the benefits of our Phoretix 1D gel and immunoblot image analysis software:
- Automatic and manual lane creation
- Background subtraction to remove noise and increase accuracy
- Automatic band detection
- Molecular Size calculation
- Quantity Calibration
- Normalisation of bands to loading controls
With our compliance module which provides the following additional features:
- Robust password control which can be configured to follow local password policy or integrate with networked Windows logins/Active directory (21 CFR 11, 11.200 (a))
- Audit trails with complete user activity, login attempts, and detailed analysis logs (21 CFR 11.10(e))
- User groups with granular access levels based on role and responsibilities
- Limit system access (21 CFR 11.10(d))
- Electronic signatures for approvers with check-in and check-out process for data archiving and approval (21 CFR 11, Subpart B)
- Emergency logins (21 CFR 11, 11.200 (3))
- Version History (21 CFR 11, 11.10 (k))
- Image calibration
- Integration with Windows Active Directory for easy user login
Installation Qualification and Operational Qualification (IQOQ)
In addition to supplying a copy of our 1D image analysis software fully compliant with 21 CFR Part 11/EU Annex 11/GxP we also offer comprehensive Installation and Operational Qualification packages which ensure the software has been installed correctly and is operating compliantly at customer sites.
These can be performed virtually (using software like Microsoft Teams, Zoom and Teamviewer) or in-person on-site. Upon completion of the IQOQ, the customer will be issued with a full suite of documentation to support 21 CFR Part 11/EU Annex 11/GxP compliance including a certificate to verify that we have witnessed the software being operated correctly on-site.
Please enquire to learn more about our IQOQ packages, ideal for peace of mind within the biopharma industry.
Are you ready to ensure compliance?
Our team has supported a number of global organisations in ensuring their systems are set up correctly to track and store the required information, and that the right processes are in place for compliance with 21 CFR Part 11/EU Annex 11/GxP regulations.
Aftersales support
When you purchase from TotalLab, not only do you get access to our industry-leading advanced image analysis software but you also benefit from unlimited technical support, training and free updates to the latest version of your software on release, all included within your subscription.
If you have a question about using our software, please check our FAQ or Resources. Alternatively, you can email support@totallab.com and a member of our team will be in touch to help you.
How can I analyse a Western blot?
Phoretix 1D is our latest offering to the life science sector for analysing 1D gels and Western blots. In this tutorial series we provide an overview in the platform – watch here. And get in touch for a free trial here.
Why does automatic lane creation fail on my gel?
There could be several reasons why this happens…
- The lanes are short or have very few bands
- The lanes are too close together so the algorithm cannot split them
- The lanes are not quite the same width which is an assumption the algorithm uses
- The resolution of the image is very low and there is not enough band information
Using an AOI for lane detection can help (draw a box when in automatic detection mode) or simply try to create the lanes manually.
My question isn't listed here, where should I go?
We have more answered questions on our FAQ page here and likewise on our resources page where you may find the answer you need. If you’re still unsure you can always contact our support desk, support@totallab.com.