Phoretix 1D1D gel and western blot analysis
Audit-ready SDS-PAGE and western blot analysis
Combined with AuditSafe, Phoretix 1D meets FDA 21 CFR Part 11, EudraLex Annex 11 and GMP standards, from captured image through to final analysis and report.
- 12+ yrs
- Proven in GMP and GLP environments
- 21 CFR Part 11 + GMP
- 21 CFR Part 11 and GMP compliant with AuditSafe
- Annex 11
- EudraLex Annex 11, GAMP 5 Category 3 and ALCOA
Ensure Compliance, Accuracy, and Efficiency in Every 1D Gel Analysis
Our Phoretix 1D software is already the complete solution for analyzing 1D SDS-PAGE gel and immunoblot images, but when also combined with our AuditSafe software, it allows users to meet and even exceed FDA 21 CFR part 11, EudraLex Annex 11, GAMP 5 Category 3 or more general GMP standards/ALCOA principles for compliance within regulated or QC/QA environments, from captured image all the way through to final analysis and report production.
Phoretix 1D + AuditSafe is the trusted solution for regulated laboratories that demand 21 CFR Part 11 and GMP compliance in protein gel, SDS-PAGE, and Western blot analysis. Achieve audit-ready results, secure data integrity, and effortless regulatory reporting, all in a single, automated platform.
Our Phoretix 1D software is already trusted by the world’s leading educational, industrial and pharmaceutical companies:
Why Choose Phoretix 1D for Regulated Labs?
Combine all the benefits of our Phoretix 1D gel and immunoblot image analysis software:
- Automated Lane and Band detection
- Background subtraction to remove noise and increase accuracy
- Automatic band detection
- Molecular Size calculation
- Quantity Calibration
- Normalization of bands to loading controls
With our AuditSafe 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
- Limited 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
- Easy integration with existing enterprise level data backup solutions
Validation and IQ/OQ support
Phoretix 1D inside AuditSafe is configurable off-the-shelf software, which we class as GAMP 5 Category 3. That keeps your validation effort well below a custom system.
We supply a signed, line-by-line response to your URS or supplier questionnaire, the AuditSafe Regulatory Compliance Guide mapping every Part 11 and Annex 11 clause to a control, and an IQ/OQ protocol that we execute with you remotely or on site. Your team owns the URS, risk assessment, performance qualification on your own blots, and your SOPs.
Updates are never pushed to you. You stay on the build you validated until QA decides to move, and every release comes with signed release notes.
Phoretix 1D GMP and Part 11 FAQs
Is the standard version of Phoretix 1D 21 CFR Part 11 compliant?
No. The standard version is for research labs. The compliant version is Phoretix 1D running inside AuditSafe, which adds named user accounts, a secure audit trail, version control and electronic signatures.
Do we need to replace our gel imager?
No. Phoretix 1D opens saved images from almost any imager. Set the imager to save into AuditSafe and the raw image is under control from the moment it is saved.
We use CLIQS 21 CFR, CLIQS Version Control or TotalLab Quant GxP. How do we move?
Those products are no longer supported and Phoretix 1D inside AuditSafe replaces them. Phoretix 1D opens TotalLab Quant, TL120 and TL100 project files, and we help you plan the comparison runs QA needs before you switch.
Can reviewers approve or reject an analysis?
Yes. A reviewer with sign-off permission re-enters their user ID and password to approve the exact version checked in, or rejects it with a comment.
Can we standardize one analysis across sites?
Yes. Save an analysis as a template and send it to colleagues on the same site or another site, so every analyst runs the same method.
Our validated PCs are offline. Will that work?
Yes. AuditSafe runs on your own server with no cloud connection and activates completely offline. Tell us at quote stage if the analysis PCs are offline too and we will set up their activation with your IT team.
Already Trusted by Leading Pharma & Biotech Labs
- Proven in GMP and GLP environments worldwide for over 12 years
- Our software reduces operator error and increases reproducibility in QC workflows