Agentic AI In Pharma: Navigating Governance For Quality Assurance And IT Compliance

Agentic AI offers enormous potential for accelerating insights in Pharma, but only when paired with the rigor this industry demands. Implementing these systems requires a balance of innovation and compliance, especially as LLM‑driven workflows translate natural language into automated actions. Strong governance becomes essential. That means qualifying models through CSV or CSA principles, defining their intended scope, documenting limitations, and building guardrails that reinforce data integrity and prevent misuse.

Layered protections—including private deployments, sanitized inputs, human approval gates, governed KPIs, and secure API access—ensure the technology operates inside validated boundaries. These controls support auditability, protect regulated data, and maintain consistency across critical calculations that influence product quality and patient safety.

Explore how thoughtful governance enables AI adoption that aligns with FDA expectations, ICH Q10 principles, and ALCOA+ standards.