Governance
Find shadow AI before it creates inspection risk.
USDM maps where AI is already being used, which workflows are regulated, and what controls are required before broader deployment.
AI readiness assessment
Know where regulated AI can move fast, and where it needs control.
USDM helps life sciences organizations identify practical AI use cases, governance gaps, validation needs, and data risks before pilots become enterprise exposure.
Validation
Connect AI ambition to defensible evidence.
The assessment identifies intended use, risk classification, validation expectations, monitoring needs, and lifecycle controls for GxP-aligned AI.
Data readiness
Pressure-test the data foundation behind the model.
Teams get a clear view of data integrity, system ownership, integration gaps, and content readiness for AI-enabled workflows.
Assessment output
A practical roadmap for compliant AI execution.
The output is designed for decision-makers who need a roadmap that balances speed, compliance, and business value.
Prioritized AI use cases with risk and value scoring
Governance gaps and recommended controls
Validation and monitoring expectations by workflow
Near-term pilots and enterprise-scale readiness actions
Why USDM
Life sciences AI needs more than generic AI strategy.
USDM combines AI strategy, GxP compliance, validation, cybersecurity, cloud assurance, and managed services experience so regulated teams can move without losing control.
Built around FDA, GxP, CSA, data integrity, and audit-readiness expectations
Designed for quality, regulatory, clinical, manufacturing, PV, and IT stakeholders
Connected to implementation support after the roadmap is approved
Frequently Asked Questions
Questions leaders ask before they move.
What does an AI readiness assessment cover?
It reviews AI use cases, governance, data readiness, validation expectations, cybersecurity, vendor risk, and the operating model needed to support compliant deployment.
Is this only for companies that already use AI?
No. It is useful before pilots begin, while pilots are active, or when leaders suspect teams are already using AI without consistent oversight.
What happens after the assessment?
USDM can help prioritize use cases, design governance, validate regulated workflows, and implement AI capabilities within controlled life sciences environments.
Next step
Start with a controlled view of your AI opportunity.
Use the assessment to identify what can move now, what needs remediation, and how to scale AI with defensible governance.