AI governance for life sciences

The governance context

Life sciences organisations sit under inspection regimes that assume documented rationale, controlled change, defined ownership and traceable evidence. AI is arriving faster than those frameworks were designed to absorb, and often through tools that were bought rather than built.

AIRAS Cloud gives quality, regulatory affairs, data science, IT and clinical functions one governed register and one assessment rulebook, so an AI use case is treated with the same rigour as any other controlled process change.

AI use cases we see in this sector

Every entry below is registered, assessed and evidenced under the same rulebook, whether it was built internally or arrived embedded inside a tool you already own.

• Literature review and evidence synthesis assistance
• Candidate screening and target prioritisation models
• Clinical trial feasibility and site selection analytics
• Manufacturing yield, deviation and batch analytics
• Pharmacovigilance case triage support
• Regulatory document drafting assistants
• Quality event classification and trend detection
• Embedded vendor AI in validated systems

Obligations the assessment reflects

Screening logic, review routes and evidence expectations reflect the obligations of the sector rather than a generic risk template.

• Documented intended use and defined operating boundary
• Validation posture proportionate to assessed risk
• Data integrity and record-retention expectations
• Change control before material modification
• Human oversight where patient or product impact exists
• Supplier and embedded-AI due diligence

The evidence you end up holding

Governance only counts when it can be produced on request. Each record exports as an assessment and decision pack with the reasoning, the controls, the approvals and the history intact.

• Assessment snapshot with ruleset version and rationale
• Control set with owners, due dates and hashed evidence
• Independent review with segregation of duties
• Versioned decision record with conditions
• Periodic reassessment and material-change history
• Exportable inspection-ready assessment and decision pack

Explore further

AIRAS Cloud does not provide legal advice and does not certify compliance. Framework references describe how the platform is designed to support governance activity.