Professional & Reflective: A Perspective on AI and Compliance
I believe progress happens through partnership, not perfection. Every audit, training session, and AI project is an opportunity to learn, improve, and strengthen trust — between people, systems, and the patients we ultimately serve.
Carl blends curiosity with calm precision. Beyond designing AI governance frameworks, he helps teams responsibly use AI to enhance pharmacovigilance, clinical trials, pharmacy practice, training, and quality systems — always with human oversight and ethical practice at the centre. Whether guiding a regulatory team or mentoring future pharmacists, his goal is simple: make innovation safe, compliance achievable, and progress sustainable.
Associations
- ARCS Australia
- Pharmaceutical Society of Australia
- Advance Pharmacy Australia
- Queensland AI Hub
- Life Sciences Queensland
Carl contributes to global discussions on AI governance and pharmacovigilance auditing, sharing insights through audits, training, and professional forums that advance the ethical use of AI and regulatory safety practices.
Biography
Carl Bufe — AI-Native GxP Auditor & Enablement Practitioner
Carl Bufe operates where GxP pressure is highest: vendor oversight that can’t afford gaps, pharmacovigilance systems that must stay audit-ready, and teams drowning in manual compliance work. He doesn’t deliver theory and disappear—he builds defensible outcomes: independent audits, governed AI adoption, and practical operating models teams can run without external dependence.
Independent GxP Auditing + Real-World Oversight
With 24 years across pharmacy, pharmacovigilance, quality systems, and clinical research, Carl brings an auditor-grade lens to how work is actually performed—not how it’s described. He conducts independent, risk-based audits across GVP, GCP (ICH E6(R3)), GLP, QMS, and CSV/data integrity, focusing on traceability, escalation pathways, CAPA effectiveness, and inspection readiness across Australia, New Zealand, and Europe.
Responsible AI Enablement That Stands Up to Scrutiny
Carl is also an AI enablement practitioner who treats AI as a regulated system—not a productivity hack. Through GxPVigilance and AusAiLab, he implements ISO/IEC 42001-aligned, human-in-the-loop workflows with audit trails, role-based access, change control, and evidence capture. His work includes literature surveillance agents, SOP/QMS copilots, drafting and compliance assistants, and audit-readiness tools—implemented with validation thinking and documentation that supports regulator questioning.
Capability Transfer, Not Consultant Dependency
Carl builds internal capability through hands-on implementation and practitioner-level training so teams can govern, operate, and improve their systems independently—whether that’s audit readiness, AI governance, or PV–QMS integration.
Fast and safe. Independent and defensible. AI supports—humans approve. Patient safety is non-negotiable.