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.