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 — The AI-Native GxP Practitioner
Carl steps in where compliance pressure is highest — when pharmacovigilance backlogs overwhelm teams, when audit findings repeat, when good people burn out trying to keep up.
He doesn't write reports from the sidelines. He builds working systems alongside teams, validates them, documents thoroughly, and transfers capability so they run independently.
Dual Mastery: GxP + AI
With 24 years across pharmacy, pharmacovigilance, quality systems, and clinical research — plus three years rebuilding these workflows using validated AI — Carl occupies an intersection no one else in Australia holds. He's a pharmacist, working QPPV, and ISO 9001/42001/13485 Lead Auditor who codes, builds AI agents with validation documentation, and automates compliance work that shouldn't consume entire teams.
His experience spans TGA environments, GCP / GLP auditing under ICH E6(R3), CSV (Computer System Validation) and medicine / medical device regulatory affairs across Australia, New Zealand, and Europe.
AI Governance Through Working Systems
Through GxPVigilance and AusAiLab, Carl designs ISO/IEC 42001-aligned frameworks embedding human-in-the-loop controls, complete audit trails, and non-negotiable patient safety. His work includes literature-watch agents, SOP copilots, and audit-readiness assistants — each with role-based permissions, logging, and change management that survives TGA scrutiny.
He implements RAG-based architectures for evidence traceability, builds validation packs proving AI outputs meet quality standards, and trains teams to maintain systems without consultant dependency.
Mission: Progress Through Practice
Fast and safe. Capability transferred, not rented. Patient safety non-negotiable.