Product
Start your validation velocity
Accelerate AI adoption in the Life Sciences, safely.
Transform compliance from a bottleneck into an accelerator for life-saving innovation
The industry's first GxP-AI Management System (AMS)
Compliant with FDA 21 CFR Part 11 & EU AI Act
The Challenge
Is your AI stuck in 'technical pilot' purgatory?
You have the technology, but face a validation gap: standard MLOps tools test technical accuracy, but they cannot prove a model is safe for its intended use. This limits the adoption of new technologies which could bring benefit to the patient.
Without a repeatable validation framework to ensure validation for intended use that mitigates unintended risks and is audit-ready, AI ecosystems remain stalled by the fear of patient harm.
From technical pilot to repeatable validation
Risk-reward
The goal of each model is to provide business benefit without adding any unintended risks to the patient.
Intended use validation
Leap from technical metrics to understanding real-world business impact to ensure AI safety
Audit-Ready Output
See an inventory of your AI ecosystem at a glance for ongoing operational monitoring and compliance
Leap from technical metrics to intended use
Why technical metrics alone will leave you stuck in "Technical Pilot" Purgatory
Technical Model Performance
Focus: Code performance & model drift
Outcome: Technical accuracy

The Gap: Great to understand model performance, but fails to provide the audit-ready proof required by Quality Directors without considering the intended use.
Intended Use Validation
Focus: Patient safety, audit readiness, business impact
Outcome: Proving Safety

The Win: Defining the context of use, model risk and credibility assessment, translating technical accuracy to ensuring in-silico safety specific to GxP regulations.
Don't just rely on technical accuracy, focus on real-world impact to allow your organization to scale your AI ecosystem confidently.
We are pharma-natives, not tech tourists
We know exactly why technical accuracy alone won't pass Quality audits. Phanero is built by industry veterans who have lived the regulations
Andy O'Connor
Founder & lead of probabilistic AI strategy
17+ years specializing in GxP validated systems & probabilistic risk.
Dr. Eva Kelly, PhD
Data integrity subject matter expert
25 years of Pharmaceutical experience. A renowned authority ensuring our approach meets strict FDA 21 CFR Part 11 and EU Annex 11 standards.
Ben O'Brien
Head of sales & marketing automation
Expert in AI & SaaS with deep pharma experience. Ben ensures that our "Land and Expand" model scales seamlessly with your compliance needs.
Ready for Validation Velocity?
Transform Compliance from a Blocker to an Accelerator
The 3-step Validation Framework
01
Risk-Reward Assessment
Define the context of use and establish the risk-reward calculation for each AI model to ensure business benefit without unintended patient risks.
02
Intended Use Validation
Move beyond technical metrics to validate real-world business impact and ensure AI safety specific to GxP regulations.
03
Audit-Ready Documentation
Generate comprehensive inventory and documentation of your AI ecosystem for ongoing operational monitoring and regulatory compliance.
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