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Platform stack

The AI infrastructure USDM builds on for regulated life sciences.

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

Each platform plays a specific role in the agentic stack.

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.

Cloud infrastructure

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
Cloud infrastructure + AI

Google Cloud

Scalable cloud and AI platform with validated compliance pathways for life sciences.

  • Vertex AI for model and agent hosting
  • Healthcare Data Engine for regulated data workflows
  • USDM independent vendor audit and Cloud Assurance
Cloud + enterprise AI

Microsoft Azure

Azure is USDM's preferred solution for GxP cloud compliance across IaaS, PaaS, and SaaS.

  • Azure OpenAI for enterprise AI model deployment
  • Azure Health Data Services for clinical and regulatory data
  • M365 and Azure compliance with USDM Cloud Assurance
Enterprise search + Work AI

Glean

Permission-aware enterprise search that gives agents governed access to regulated knowledge.

  • Connects QMS, RIM, CTMS, and document systems in one search layer
  • Agents retrieve from Glean with permission boundaries intact
  • USDM builds and validates Glean connectors for regulated domains
AI model layer

Anthropic

Claude models for reasoning-intensive regulated workflows: regulatory interpretation, clinical evidence review, and evidence assembly.

  • Optimized for long-document analysis and structured reasoning
  • Available via Amazon Bedrock within validated AWS environments
  • USDM aligns model use to intended-use and change control requirements

How it connects

Infrastructure, models, and search — in a governed sequence.

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

5

Governance layer

Human approval gates, audit trails, evidence capture, change control

GxP · Part 11 · CSA/GAMP · Human-in-the-loop

4

Domain agent layer

Quality · RA · Clinical · Manufacturing · Safety · Medical Affairs · Cybersecurity

USDM Agentic Team

3

Orchestration layer

Routing, tool dispatch, context, memory, prompt management

Intent classification · Tool selection · Context window

2

Model layer

Reasoning, long-document analysis, structured output

Claude (Anthropic) · Azure OpenAI · Vertex AI · Amazon Bedrock

1

Data & integration layer

Regulated sources, permission boundaries, version control

QMS · RIM · CTMS · MES · Safety DB · ERP · Glean · SharePoint

Why the platform layer matters

85% of organizations are adopting AI agents faster than their security teams can assess them.

— 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.

Next step

The platform is the foundation. Governance is the operating system.

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

Design the governed operating model your team needs.

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.

  • Agentic team design scoped to your domain and regulatory context
  • GxP-validated AI agents with human-in-the-loop controls
  • Audit trails from prompt to approval for every agent action
  • Operates inside your existing systems: QMS, Veeva, ServiceNow, ERP

Start here

Talk to USDM

Tell us which domain or workflow you're trying to accelerate and we'll map a governed path forward.

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