
by Antonina Burlachenko
Simplify workflows, reduce manual effort and shift to proactive compliance
Regulatory pressure is only increasing, and staying compliant means keeping up with constant change. For businesses, this isn’t just about avoiding penalties – it’s about building trust, setting clear operational standards and staying resilient.
Compliance monitoring plays a key role in this – and what was once manual and error-prone is now faster and smarter thanks to AI agents.
AI regulatory agents act as always-on digital assistants, built to monitor, analyze and act on complex regulatory data — in real time. They scan vast information sources, learn from patterns,and adapt to evolving regulations.
Here’s how they can be applied across key regulatory and compliance functions:
What are the benefits of AI Agents for compliance monitoring?
Risk mitigation: Avoid fines, inspection findings, or delays due to missed changes
Efficiency gains: 30–50% reduction in manual monitoring & triage workload
Strategic agility: Faster, data-backed decisions on regulatory response
Audit readiness: Built-in tracking, traceability, and justification for actions
Cost savings: Less dependence on external alerts + more internal capacity
AI-powered assistant within Veeva QualityDocs
Global Biopharmaceutical Company
Challenge: Manual document workflows in Veeva QualityDocs were slow and error-prone.
Solution: Star built an AI PoC to streamline writing, editing, and compliance checks.
Impact: Early results show faster document creation and improved quality.
Embedding generative AI into QMS workflows
ins2outs – Digital Quality Management System Provider
Challenge: Manual regulatory processes were time-consuming and lacked intelligent automation.
Solution: Star designed and implemented an AI roadmap to embed generative features into document generation, research, and data classification.
Impact: Enabled faster document creation, smarter regulatory search, and automated feedback categorization.