Phanero
Accelerating GxP-AI Adoption, Safely
Phanero is the industry’s first GxP-AI Management System (AMS), specifically engineered to transform compliance from a bottleneck into an accelerator for life-saving innovation. While standard MLOps tools are adept at measuring technical accuracy, they often fail to prove a model is safe for its intended use. Phanero bridges this “validation gap,” helping Life Sciences organizations escape “Technical Pilot” purgatory and move high-value AI models into production with confidence.
The platform serves as a dedicated governance layer for the entire AI ecosystem; whether managing internal models, third-party vendors, or AI-augmented software.
Phanero provides:
- The Oversight Layer (GxP-AI Inventory): A centralized dashboard to register, track, and manage the risk profile of every AI asset, preventing "shadow AI" and providing total visibility into the regulatory status of your models.
- The Execution Layer (3-Step Validation): A standardized, repeatable framework that includes Initial Model Validation (benchmarking), Real-World Evaluation (Human+AI performance vs. manual baselines), and Operational Integration (workflow monitoring).
- Audit-Ready Governance: Phanero automatically generates validation documentation, ensuring every model decision is traceable and defensible. Our approach is designed to meet strict FDA 21 CFR Part 11 and EU Annex 11 standards.
Built by “pharma-natives” with decades of experience in validated systems and quality assurance, Phanero understands that technical accuracy alone won’t pass a Quality audit. We provide the repeatable framework necessary to prove AI safety and get life-saving innovations to patients faster.