What Is AI Governance?
AI governance is the set of policies, processes, and controls that ensure artificial intelligence systems operate safely, transparently, and in compliance with regulations. For life sciences, it covers model validation, access control, audit trails, bias monitoring, and regulatory evidence collection across every AI interaction.
Life sciences organizations face unique AI governance challenges. Unlike general enterprise AI, pharma and biotech AI systems often generate records used in regulatory submissions, clinical decisions, and quality processes. These records must meet specific regulatory requirements — including FDA 21 CFR Part 11 for electronic records, EU AI Act requirements for high-risk systems, and GxP standards for manufacturing quality.
Without purpose-built AI governance, organizations risk regulatory non-compliance, data integrity failures, and audit findings that can delay drug approvals and trigger enforcement actions.
BioCompute Connection
BioCompute provides full-stack AI governance across five integrated products — AI Gateway, Agentic Hub, Evidence Engine, Compliance Manager, and Evidence Books — purpose-built for life sciences regulatory requirements.