Built for regulated teams who need control, not hype

Independent GxP Audits & AI Enablement for Pharmaceutical Teams

Australian consultancy helping sponsors, CROs and clinical teams run independent audits and governance-first AI enablement—reducing manual burden and keeping you inspection-ready as AI enters routine workflows.

We support AI only where it’s defensible: clear scope, documented oversight, ROI, audit trails, and human accountability designed in from day one.

Book a 30-Minute Scoping Call

Human judgment stays accountable. AI stays assistive.

At our core:

Clarity. Control. Confidence. Integrity.

Four Paths. One Foundation.

Independent GxP control — whether you need audit assurance, governed AI adoption, or both.

GxP Auditing Services

Problem: GxP oversight is spread across vendors, systems, and teams—gaps in evidence, governance, and data integrity can build quietly until inspection.

Outcome: Independent, risk-based audits that strengthen traceability and inspection readiness across GCP/GVP/GLP, QMS, and CSV.

Audit Areas

Pharmacovigilance (GVP)
Clinical Research (GCP)
Laboratory Operations (GLP)
Quality Management Systems (QMS)
Data Management & CSV
Pharmacy / Medication Compliance

How We Work

Risk-based, evidence-focused audits
Regulatory lens — we audit how inspectors assess risk
Actionable findings with realistic timelines
Pre-audit and mock inspections available

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Responsible AI Enablement

Problem: AI interest is accelerating, but most teams don’t yet have clear rules for scope, oversight, documentation, or vendor assurance.

Outcome: A governance-first pathway to pilot AI safely—defined boundaries, human accountability, and evidence capture to support future assurance.

Service Areas

AI Readiness Assessment
Vendor Evaluation & Independent Validation
Governance Framework Design
Implementation Support
AI for Pharmacovigilance / Regulatory Affairs (Specialty)
AI for Clinical Trials / Pharmacy (Specialty)

How We Work

Governance-first, technology-second
Tools you already own (Copilot, enterprise LLMs, vendor platforms)
Pilot-first — prove one use case before scaling
Capability transfer — your team runs it independently

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Training & Capability Building

Problem: Teams lack internal capability and confidence, relying heavily on external expertise.

Outcome: Role-based capability to manage AI, governance, and inspections independently.

Core Training

AI Governance for GxP
ISO/IEC 42001 (Practical)
Human-in-the-Loop Oversight
Privacy & Data Protection for AI
Safe Use of AI Tools
AI-Assisted GxP Writing
Validation Thinking for AI

How We Work

Governance-first, regulator-aware
Hands-on, real GxP scenarios
Privacy and data controls embedded
Capability transfer to your team

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PV System Design & QMS

Problem: PV processes and QMS links often evolve inconsistently, creating gaps in oversight, metrics, and inspection defence.

Outcome: Regulator-aligned PV system design and independent audits that strengthen governance, traceability, and sustained compliance.

Service Areas

PV System & Process Design (pre/post-market)
PVIP Readiness & Inspection Defence
QPPV / Safety Governance Models & Metrics
PV–QMS Integration (SOPs, change control, CAPA)
Operational Oversight (timelines, escalation, QC)
Risk Management and Regulatory Support
Device Vigilance Support

How We Work

Risk-based, evidence-focused approach
Designed for auditability and regulator questioning
Clear governance, roles, and metrics
Practical outputs your team can run

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AI-Native Implementation: Built for Capability, Not Reports

We don’t write 40-page reports and disappear. We build AI-enabled systems with your team, validate and document them to inspection standards, train your people to run them independently, and leave you capable—not dependent.

How we work

Co-build, don’t just consult
Human-in-the-loop governance
Regulator-aligned by design

our team

Meet our team

Behind every audit, assurance report, and compliance framework is a team built on clarity, control, and integrity.
At GxPVigilance, we combine regulatory experience, medical insight, and digital precision — creating a collaborative approach that strengthens both systems and people.