Every pharmaceutical organization we speak with wants to use AI. Anomaly detection. Predictive quality. AI-accelerated validation. GenAI agents for deviation support and SOP guidance. Almost none of them have the data foundation required to do any of this at scale in a GxP-compliant way. This is not a technology problem. The AI models exist. The regulatory guidance, FDA's 2025 AI Draft Guidance, Annex 22 from EMA, the 2026 CSA Guidance, is increasingly clear. The problem is t
