AI Governance & ComplianceforPharmaceuticals

AI Governance & Compliance for Pharmaceuticals

Pharmaceutical AI lives under GxP and FDA expectations, which means validated systems, not best-effort prototypes. Any AI involved in manufacturing, pharmacovigilance, evidence synthesis, or regulatory submissions must carry computer system validation, audit trails, and change control that an inspector can follow. Pharmacovigilance models that triage adverse events need documented sensitivity and human review. Evidence synthesis and submission drafting must show traceable sourcing, because the FDA will ask where every claim came from. ALCOA+ data integrity principles apply to AI outputs just as they do to lab records. We deliver the validation packages, controls, and documentation that let you use AI in regulated workflows and still satisfy GxP inspections.

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How we deliver it

AI Governance & Compliance, built for pharmaceuticals

We bring AI systems under computer system validation with documented intended use, risk assessment, IQ/OQ/PQ evidence, and change control that maps to GxP expectations.

We enforce ALCOA+ data integrity on AI inputs and outputs, with tamper-evident audit trails an FDA inspector can trace end to end.

We design human review and documented sensitivity testing for pharmacovigilance and safety-signal models so nothing reportable is missed.

We build source traceability into evidence synthesis and submission tools so every AI-generated statement links back to its underlying record.

Where it pays off in pharmaceuticals

CSV for AI

Validate AI systems with intended-use definition, risk assessment, and qualification evidence so they hold up in GxP audits.

Pharmacovigilance Review

Govern adverse-event triage models with documented sensitivity and mandatory human review of safety signals.

Submission Traceability

Ensure AI-drafted submission content links every claim to its source, giving reviewers a defensible evidence chain.

Data Integrity Controls

Apply ALCOA+ principles and tamper-evident audit trails to AI outputs across regulated manufacturing and quality workflows.

AI that drafts evidence summaries and triages safety signals ships as a validated system, removing the inspection risk that keeps most pharma AI stuck in pilots.

Pharmaceuticals AI, answered

Yes. We bring them under computer system validation with documented intended use, risk assessment, and qualification evidence, plus change control. The result is an AI system you can present in a GxP inspection with the same rigor as any other validated computerized system.

We apply ALCOA+ principles to AI inputs and outputs and maintain tamper-evident audit trails an inspector can follow end to end. That keeps AI-generated data attributable, legible, and traceable to its source, which is the standard the FDA holds your records to.

It can be, with the right governance. We require documented sensitivity testing and mandatory human review of safety signals, so the model accelerates triage without risking a missed reportable event. Every decision is logged for your safety and regulatory teams.