AWS
GxP-validated cloud infrastructure for regulated data workloads, analytics, and AI hosting.
- AWS HealthLake for FHIR-based data and analytics
- Amazon Bedrock for governed model hosting
- USDM Cloud Assurance for GxP-validated AWS environments
Platform stack
Trust in an agentic workflow starts with the platform underneath it. USDM builds on a curated stack — validated for regulated environments and connected to our GxP delivery model.
Cloud infrastructure
AWS · Azure · Google Cloud
AI model layer
Claude · Azure OpenAI · Vertex AI
Enterprise search
Glean Work AI platform
Validation & compliance
USDM Cloud Assurance
Five platform relationships
USDM doesn't use every AI platform. We use the ones with validated procurement paths, regulatory-aware data handling, and production-grade reliability for life sciences.
GxP-validated cloud infrastructure for regulated data workloads, analytics, and AI hosting.
Scalable cloud and AI platform with validated compliance pathways for life sciences.
Azure is USDM's preferred solution for GxP cloud compliance across IaaS, PaaS, and SaaS.
Permission-aware enterprise search that gives agents governed access to regulated knowledge.
Claude models for reasoning-intensive regulated workflows: regulatory interpretation, clinical evidence review, and evidence assembly.
How it connects
Every agentic workflow runs on a stack. At the base, cloud infrastructure (AWS, Azure, or Google Cloud) provides the validated, GxP-aligned compute and storage. Above that, model providers (Anthropic Claude, Azure OpenAI, Vertex AI) handle the reasoning work. Glean connects enterprise knowledge — QMS, RIM, CTMS, and document systems — to agents with permission boundaries intact.
USDM sits above all of it: designing the domain agent layer, writing validation evidence, and ensuring that governance controls (human approval gates, audit trails, change control) wrap the entire stack. The result is a workflow that is not just functional — it is defensible.
The 5-layer stack
Governance layer
Human approval gates, audit trails, evidence capture, change control
GxP · Part 11 · CSA/GAMP · Human-in-the-loop
Domain agent layer
Quality · RA · Clinical · Manufacturing · Safety · Medical Affairs · Cybersecurity
USDM Agentic Team
Orchestration layer
Routing, tool dispatch, context, memory, prompt management
Intent classification · Tool selection · Context window
Model layer
Reasoning, long-document analysis, structured output
Claude (Anthropic) · Azure OpenAI · Vertex AI · Amazon Bedrock
Data & integration layer
Regulated sources, permission boundaries, version control
QMS · RIM · CTMS · MES · Safety DB · ERP · Glean · SharePoint
Why the platform layer matters
— USDM AI Governance for Life Sciences: Enterprise Framework
The platform layer is where that gap lives. When agents operate on validated infrastructure with defined permission models, procurement relationships, and audit-ready evidence, the security and compliance conversation moves from “is this safe?” to “here's the evidence.”
Procurement
AWS, Azure, Google, and Glean are already in most life sciences organizations. USDM builds on what you already trust.
Validated environments
USDM Cloud Assurance covers GxP validation for AWS, Azure, and Google Cloud environments.
Model governance
Anthropic model use is scoped to intended use, with change control for prompt and model updates.
Further reading
Next step
See how USDM layers validation, human approval gates, audit trails, and change control on top of the platform stack.
Talk to an agentic AI specialist
USDM can help define the workflow, the validation scope, and the oversight controls — so the first use case is worth automating and audit-ready from day one.