Life sciences organizations know what AI can do. What most don’t yet have is the infrastructure to do it safely, repeatably, and in a way that survives regulatory scrutiny.
In this comprehensive whitepaper, USDM’s AI Center of Excellence lays out the operational framework to close that gap — covering the AI system lifecycle, partner platform risks, vendor assessment, citizen development, and how to get started in 90 days.
Why This Matters Now
- The EU AI Act’s high-risk enforcement provisions take effect August 2026 — requiring conformity assessments, technical documentation, and continuous monitoring.
- Partner platforms including Veeva, Box, and ServiceNow are embedding AI directly into validated GxP environments, often without explicit customer action.
- Board-level pressure to reduce compliance costs 15–25% while simultaneously accelerating digital transformation.
Organizations that build unified AI governance infrastructure gain a compounding advantage. Those that don’t face a new category of regulatory exposure that will only become clearer as FDA and EU enforcement guidance matures.
Who This Is For
- Quality and Regulatory Affairs leaders managing AI adoption in GxP environments
- CIOs and CTOs responsible for validated platform governance
- Chief AI Officers and Digital Transformation leaders building scalable AI programs
- Compliance and Validation teams navigating FDA, EU AI Act, and ISO 42001 simultaneously
Contributors
- John Petrakis, Chief AI Officer
- David Blewitt, VP of Digital Trust and AI Governance
- Enric Cullell, AI Quality Lead
- Elena Mirón, AI Program Manager
- Lisa Om, VP Marketing & Communications
Want proof that AI works in regulated environments? Download USDM’s AI in Life Sciences: 47 Use Cases for Quality, Regulatory, Clinical, and Manufacturing Teams — with quantified outcomes and inspection-ready architecture to help you move from pilot to production with confidence.