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

Intended Use Validation

Focus: Patient safety, audit readiness, business impact

Outcome: Proving Safety

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

18+ 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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