Six integrated practice areas — each addressing a distinct AI governance, validation, or deployment challenge unique to regulated life sciences. Click any service to expand details, deliverables, and timelines.
Structured diagnostic across six maturity dimensions — strategy, governance, data, talent, deployment, and ethics. Produces a calibrated AI maturity score, shadow AI inventory, peer benchmarks, and a prioritized roadmap. USDM’s validated methodology derived from 50+ life sciences AI engagements.
AI Maturity scorecard · Executive readiness brief · 90-day action roadmap · Use case pipeline
Implementation of USDM’s proprietary TRUST-AI governance framework — Transparent, Reliable, Unbiased, Secure, Tested, Accountable. Establishes AI policies, SOPs, risk classification, and governance committee structure aligned to FDA, EU AI Act, and ISO 42001.
AI governance SOP suite · RACI matrix · AI risk register · Board-ready risk posture report
Facilitated workshop using USDM’s AI Use Case Scoring Matrix to identify, score, and prioritize AI opportunities by business value, feasibility, and regulatory risk — followed by PoC delivery for top-priority candidates within GxP guardrails.
Scored use case portfolio · Executive decision brief · PoC build-out for 1–2 priority use cases
GxP-aligned validation strategies for AI/ML systems using FDA’s Computer Software Assurance framework — risk-based, documentation-right-sized, and designed for continuous SaaS release cycles. Includes LLM output validation and GAMP 5 Category 5 documentation.
AI validation strategy · IQ/OQ/PQ adapted for AI · LLM output validation package · Performance monitoring plan
Structured assessment and continuous monitoring of AI vendors and tools against USDM’s AI TPRM framework — covering model transparency, data governance, regulatory compliance, SLA adequacy, and contractual risk. OSINT-powered intelligence dashboards. Scalable to 150+ vendor portfolios.
Vendor risk profiles · TPRM scorecard · Procurement guidance · Contractual requirement templates
End-to-end EU AI Act compliance pathway — risk classification across all AI systems, Annex IV conformity assessment documentation, unified compliance mapping across EU AI Act + FDA + GDPR + ISO 42001, and ongoing regulatory intelligence monitoring.
AI system inventory & risk classification · Conformity assessment documentation · Unified multi-jurisdiction compliance matrix
Subscription-based ongoing AI governance replacing the need for a full-time internal AI governance function. Covers policy maintenance, regulatory monitoring, AI system intake review, TPRM continuous monitoring, and quarterly board reporting — all as a predictable monthly cost.
Monthly governance reports · Quarterly board briefings · Regulatory update alerts · New system intake assessments
USDM’s proprietary AI-powered GxP process automation platform built on ServiceNow — intelligent CAPA routing, automated deviation classification, predictive escalation, and automated regression testing. Fully validated, full audit trail, production-ready.
Deployed AI workflows · Automated test suite · Validation documentation · Labor reduction measurement