A practical, inspection-aware view of how AI is being applied across regulated life sciences operations today.
Rather than focusing on abstract AI concepts or experimental pilots, this white paper documents concrete use cases across eight functional domains—Quality, Regulatory Affairs, Clinical Development & Operations, Manufacturing & Supply Chain, Safety & Pharmacovigilance, Medical Affairs, Cybersecurity & Third-Party Risk Management, and Corporate & Enabling Functions. Each use case is grounded in real operational challenges and illustrates how intelligent automation can be embedded into enterprise workflows to improve speed, consistency, and compliance outcomes.
The dossier is designed to be read by function. Each section can stand alone, allowing leaders and practitioners to focus on the areas most relevant to their responsibilities while maintaining a consistent architectural and governance perspective across the enterprise.
Why This White Paper Matters
Life sciences organizations are under increasing pressure to do more with less—faster execution, greater transparency, and stronger inspection readiness—without proportional increases in headcount or cost.
Manual, document-heavy operating models that once supported compliance are now a structural liability. They drive longer cycle times, inconsistent execution, rising compliance cost, and growing inspection risk. At the same time, AI capabilities are rapidly becoming embedded within the systems organizations already rely on, fundamentally changing what is possible.
This white paper matters because it moves the conversation from whether AI should be adopted to how it can be applied responsibly and defensibly in regulated environments. It shows how intelligent automation, when designed with clear intended use, human oversight, and auditability, can reduce the cost of compliance while strengthening inspection readiness—rather than compromising it.
What You’ll Learn
Readers of this white paper will gain:
- A clear view of high-impact AI use cases across eight life sciences functional domains, organized by operational relevance rather than technology hype
- How AI capabilities progress from assistive automation to generative reasoning and predictive, agentic intelligence—and where each is appropriate
- Practical examples of inspection-relevant automation, including inspection readiness, batch record review by exception, TMF quality intelligence, labeling impact analysis, case processing, and MLR review
- How to evaluate AI capabilities already embedded in enterprise platforms versus when to buy, build, or extend
- Design principles for human-in-the-loop governance, auditability, and defensible AI use in GxP environments
- A pragmatic path to lowering compliance cost while improving speed, consistency, and regulatory confidence
Who Should Read This
This white paper is intended for leaders and practitioners responsible for regulated operations, compliance, and enterprise platforms, including:
- Quality, Regulatory, Clinical, Safety, Manufacturing, and Medical Affairs leaders
- CIOs, CTOs, and digital transformation leaders in life sciences
- IT, data, and platform owners supporting GxP systems
- Cybersecurity and third-party risk leaders supporting regulated data and processes
- Executives evaluating AI strategy through the lens of operational impact and inspection readiness
- Each section is written so readers can engage deeply with their own domain while understanding how intelligent automation scales across the enterprise.
About USDM Life Sciences
USDM Life Sciences partners with regulated organizations to embed intelligent automation into existing enterprise platforms in a way that reduces compliance cost, accelerates execution, and remains defensible under inspection.
USDM’s approach is platform-first and architecture-led, focusing on activating AI where it materially improves regulated workflows—without fragmenting systems, weakening governance, or introducing inspection risk.
Contributors to this White Paper include:
- Jennell Botero, Principal Consultant
- Hovsep Kirikain, Vice President of Strategy and Operations
- Mark Ohrvall, Vice President of Delivery Operations
- Lisa Om, Vice President of Marketing & Communications
- John Petrakis, Chief AI Officer
- Brian Rankin, Head of Cybersecurity Services
- Brittany Walker, Principal Consultant
Continue the Conversation at the USDM Summit
This white paper is part of a broader conversation on how life sciences organizations can move from AI intent to inspection-ready impact.
At the USDM Summit, industry leaders, practitioners, and regulators explore these use cases in greater depth—sharing real-world lessons, architectural patterns, and governance approaches that work in regulated environments.
If this dossier resonates with your current challenges, the Summit is where strategy becomes execution.