Audit-Ready Colony Counting for Regulated QC Labs
Bring fast, objective, automated colony counting into your GMP environment without compromising on compliance. Phoretix Colony Counter paired with AuditSafe delivers 21 CFR Part 11, EU Annex 11 and GMP-compliant results, from raw plate image to signed, audit-ready report. It is the same trusted colony counting software used in research labs worldwide, wrapped in a compliance layer that pharmaceutical regulatory departments have relied on for over a decade.
Moving Colony Counting from R&D into a Regulated Environment
Manual colony counting is slow, subjective and difficult to defend in an audit. But moving an established counting method into a GMP-regulated QC lab usually comes with a heavy price tag: replacing perfectly good software and instruments simply because the original tools were never built for 21 CFR Part 11 or EU Annex 11.
AuditSafe changes that equation. Rather than forcing you to rip out and replace your workflow, it wraps your existing Phoretix Colony Counter setup in a secure, vendor-neutral compliance layer. You keep the counting software your scientists already know, and you gain the data integrity controls your quality and regulatory teams require.
One Platform: Automated Counting, Built-In Compliance
Phoretix Colony Counter automates the counting of bacterial colonies, cells, ELISpot spots and particulates, and measures zones of inhibition from disk and well diffusion assays. It produces consistent, reproducible results in under a minute per image, across every operator and every plate.
AuditSafe sits around that software as a data control layer, instantly adding the user access controls, electronic signatures and secure, time-stamped audit trails required by the FDA and EU Annex 11. As long as your data stays within AuditSafe, every action that creates, modifies or deletes a record is tracked, attributed to a named user and preserved for review.
The result is a single, defensible chain of custody, from the moment a plate image is captured to the moment a counted, signed result leaves your lab.
How Phoretix Colony Counter with AuditSafe Meets 21 CFR Part 11
Secure, time-stamped audit trails
Every action that creates, modifies or deletes a record is recorded automatically with the date, time and user. Changes never obscure previously recorded information, and the full history of each project is retained for as long as the records require.
Electronic signatures
Records can be signed electronically, with each signature uniquely and permanently linked to a named individual and to the data it approves. Signatures cannot be copied, transferred or reused to falsify a record.
User authentication and access control
Configurable permission levels ensure only authorized individuals can access the system, sign records and perform defined operations. AuditSafe prevents duplicate username and password combinations and supports password ageing, lockouts and de-authorization of compromised credentials.
Data integrity to ALCOA+ principles
The system is built around the ALCOA+ framework, keeping your data attributable, legible, contemporaneous, original and accurate, the standard auditors expect during inspection.
Check-in / check-out collaboration
Analysts can collaborate on the same project without overwriting one another’s work, eliminating a common source of data integrity failures.
Human- and machine-readable export
All electronic records and signatures can be exported in inspection-friendly formats such as CSV and PDF, so you can demonstrate compliance on demand.
Vendor-neutral by design
AuditSafe is not locked to a single instrument. It can secure your Phoretix Colony Counter data and, if you need it, retrofit a mixed fleet of third-party software and instruments under one compliance layer.
Validation and IQ/OQ Support Included
Compliance is more than software. TotalLab offers IQ/OQ validation services alongside your AuditSafe purchase to help you document that the system was installed and is operating as intended, against your user and functional requirements. With more than 24 years in life science software and a 21 CFR Part 11 implementation already accepted by the regulatory departments of some of the world’s largest pharmaceutical companies, we know exactly what auditors look for, and how to help you pass with confidence.
Built for Regulated QC and Release Testing
- Microbial colony counting and CFU enumeration for QC and environmental monitoring
- Bioburden and sterility-related counting workflows
- Zone of inhibition measurement for antibiotic and antimicrobial testing
- ELISpot, cell and particulate counting
- Any plate-based counting method being transferred from R&D into a GMP environment
Trusted by the World’s Leading Pharmaceutical Companies
For over 24 years, TotalLab has built image analysis and compliance software for the life sciences. Our 21 CFR Part 11 implementation has been operating safely inside major pharmaceutical regulatory environments for more than a decade. When you choose Phoretix Colony Counter with AuditSafe you get software that is genuinely device-agnostic, free software updates, and direct support from the people who built it, not an outsourced help desk.
“TotalLab’s 21 CFR implementation is probably the best I’ve ever seen and administered on-site.”
– David Morton, Associate OT Specialist, Lonza
See Audit-Ready Colony Counting on Your Own Plates
Start a free trial of Phoretix Colony Counter, or book a 30-minute walkthrough with a TotalLab compliance expert to see exactly how AuditSafe brings your counting workflow into a 21 CFR Part 11 environment.
Frequently Asked Questions:
Is Phoretix Colony Counter 21 CFR Part 11 compliant on its own?
Phoretix Colony Counter becomes 21 CFR Part 11 and EU Annex 11 compliant when combined with AuditSafe, TotalLab’s compliance overlay. AuditSafe adds the audit trails, electronic signatures and user access controls required by the FDA and EU regulators, while Phoretix Colony Counter performs the counting and measurement.
Do I have to replace my existing imaging hardware?
No. Phoretix Colony Counter is device-agnostic and works with images from any imaging system you already own. AuditSafe is vendor-neutral and wraps your existing setup rather than replacing it.
Does TotalLab help with validation?
Yes. TotalLab offers IQ/OQ validation services alongside AuditSafe to support your installation and operational qualification against your requirements.
Can AuditSafe also make my other lab software compliant?
Yes. AuditSafe can retrofit a mixed fleet of third-party instruments and software under a single 21 CFR Part 11 compliance layer, as well as securing your TotalLab analysis software.
How can I try it?
Request a free trial of Phoretix Colony Counter to evaluate the counting software on your own data, then speak to our team about adding AuditSafe for full compliance.