Why GxPVigilance Exists
Vendor oversight is now one of the highest-risk pressure points in GxP operations. External providers run critical activities, yet findings repeat, transparency varies, and internal oversight is stretched—while teams are expected to move faster without compromising compliance or patient safety.
GxPVigilance exists to fix this through independent vendor audits and AI enablement done correctly. We audit how providers actually operate (not just what SOPs claim), testing real-world governance: oversight models, data flows, documentation, training, escalation, CAPA effectiveness, and inspection readiness. In parallel, we help organisations adopt AI to reduce manual burden, improve consistency, and accelerate throughput—but in a controlled way: validated workflows, clear ownership, documented controls, traceable outputs, and defined human approval points.
AI delivers value when it’s governed. Patient safety is non-negotiable. Independence is maintained. AI supports—humans approve. Capability is built, not outsourced.
What We Do
GxPVigilance provides independent GxP (GCP, GLP, GDP, CSV) auditing, pharmacovigilance consulting and AI-enabled transformation services across pharmacovigilance, clinical research, quality systems, regulatory affairs, manufacturing and data management. We serve pharmaceutical sponsors, CROs, investigator sites, and healthcare organisations across Australia, New Zealand, and APAC.
Four Core Services
GxPVigilance’s Values
Clarity — Plain-English guidance and clean artefacts so everyone knows what, why, and by when.
Control — Traceable, documented workflows with clear ownership so your team runs the system.
Confidence — Proof you can present, with reproducible results and full traceability.
Integrity — Patient safety first; human-in-the-loop, no shortcuts, no black boxes.
- Partnership — Co-designed, transparent, with capability transfer so you stay independent
Beliefs
Compliance should enable improvement, not fear.
AI is a tool for clarity, not a shortcut around responsibility.
Teams should own their systems — not rent dependency.
Transparency builds trust with regulators and patients.
- Expertise should be shared and built, not hoarded
- Patient safety remains non-negotiable
Who We Are
GxPVigilance is an independent consulting practice led by Carl Bufe, a pharmacist, GxP auditor, and AI practitioner with 24+ years of hands-on experience across pharmacovigilance, quality systems, clinical research, pharmaceutical operations, and regulatory affairs.
Location & Scale
Based in Brisbane with a Sydney office, we serve regulated teams across Australia, New Zealand, and APAC. We work with trusted subject-matter partners and use client-approved AI providers (Microsoft 365 Copilot, Azure OpenAI, Anthropic, Google Gemini) to accelerate delivery and consistency—while keeping client data confidential and preserving audit independence.
AI Governance & Transparency
All AI-assisted work is ISO/IEC 9001, ISO/IEC 42001 and GAMP 5-aligned, with full traceability, human-in-the-loop review, and transparent documentation.
Meet Carl Bufe – Principal Consultant & Founder
Principal Consultant & Founder
Pharmacist | GxP Auditor | AI Practitioner
Career Summary
Carl brings 24+ years of hands-on regulatory, clinical, and operational experience in pharmaceutical organisations, including clinical research organisations (CROs), healthcare systems, and pharmaceutical businesses. His background spans pharmacovigilance, quality assurance, clinical operations, pharmacy practice, and data management—giving him a rare cross-functional perspective on how GxP systems actually work under pressure.
Before founding GxPVigilance, Carl held senior roles in quality, compliance, and pharmacovigilance at major clinical research and pharmaceutical organizations. He’s audited GCP compliance across Australia and internationally, designed and validated pharmacovigilance systems, conducted due diligence assessments for sponsors and CROs, and mentored teams in AI governance and regulatory affairs. His work has directly supported TGA inspection readiness, FDA submissions, and EMA compliance across multiple therapeutic areas.
Expertise & Focus Areas
Pharmacovigilance & Safety Systems
A-PVCP/QPPV model design, ICSR workflows, signal detection and oversight, expedited reporting, safety database management, medical review, sponsor-investigator communication.
GCP Auditing & Vendor Qualification
Sponsor and site audits, vendor due diligence, TGA inspection readiness, ICH E6(R3) transition, GCP systems assessment, research operations quality.
AI Governance & Implementation
ISO/IEC 42001 and GAMP 5-aligned AI lifecycle management, AI-enabled pharmacovigilance and regulatory intelligence workflows, human-in-the-loop safety systems, validation and testing protocols.
Quality Systems & Data Integrity
Quality management systems design, data integrity (ALCOA+), electronic records and audit trails (COTS and custom systems), vendor assessment, compliance strategy.
Clinical Trial Operations
Research operations quality, pharmacy and clinical manufacturing compliance, clinical supply chain oversight, study startup and operations readiness.
Qualifications & Credentials
Professional Qualifications
- Bachelor of Pharmacy (Honours)
- Postgraduate Diploma in Quality Systems
- Bachelor of Commerce (Risk & Finance)
- Bachelor’s Information Systems
Auditor & Technical Certifications
- ISO Lead Auditor (ISO 9001, ISO 13485, ISO/IEC 42001)
- Certificate in Computer System Validation (CSV)
- GCP Training (ICH E6 R2/R3, TGA/MHRA-aligned)
- Pharmacovigilance & AI Governance Practitioner
What Makes Us Different
Dual Mastery – GxP + AI in one practice.
Implementation Focus, Not Assessment-Only
Patient Safety Non-Negotiable
Pharmacist and Builder – not just consultant.
Australian TGA and International Context Expertise
Training-First Approach – we transfer knowledge.
Testimonials / Motivations
GxPVigilance helped us clear a 2-month backlog in 2 weeks.