Independent GxP Auditing for Vendor Oversight & Real Control
Validate what suppliers claim, strengthen evidence trails, and tighten governance across GCP, GVP, Pharmacy, GLP, CSV and Data Management — without performative compliance.
We focus on quality assurance: vendor qualification audits, oversight routines, and documented decision pathways that hold up in real operations.
Human judgment stays accountable. Oversight stays defensible.
At our core:
Clarity. Control. Confidence. Integrity.
Is Your Clinical Operation Ready — and do you have a reliable auditing solution in Australia?
Running GCP-compliant clinical trials in Australia is becoming harder, not easier. Regulatory oversight is intensifying. Protocol deviations keep happening despite training. Most sponsors don’t know their true compliance posture until an inspection notice arrives.
Whether you’re an Australian sponsor preparing for regulatory review, or an international sponsor qualifying Australian sites and vendors, you need independent local audit support you can rely on — aligned to Australian regulatory expectations and international ICH GCP requirements.
The Reality
What sponsors and clinical teams are dealing with today:
- TGA GCP Inspection Program is active and findings are increasingly granular
- Some sponsors don’t have a clear, evidence-based view of their compliance posture
- Manual CAPA management often fails to close findings within required timelines
- Small to mid-size organisations lack internal GCP expertise
The Risk
If you haven’t had an independent audit recently, you may be relying on assumptions =
- Delayed approvals or study phase transitions while evidence gaps are addressed
- Formal observations and reputational impact with partners and stakeholders
- Remediation under scrutiny while operational deadlines continue
- Lost time and budget fixing gaps under pressure instead of on your timeline
The Opportunity
Audit on your terms, before timelines and stakeholders force reactive fixes. Get independent, local assurance aligned to Australian expectations and ICH GCP requirements.
Who This Is For
Choose the scenario that matches your role. Each engagement is tailored to your operating context, timelines, and evidence needs.
For CROs & International Vendors
Your Challenge:
Australian regulatory expectations (TGA, HREC, local operational constraints) differ from those of the FDA/EMA.
You need a ground-truth assessment of capability, not just claims.
Your decision timeline is tight—you need credible findings fast.
- ✓Rapid due diligence audit (2 weeks, independently verified)
- ✓Assessment in both the ICH and Australian regulatory context
- ✓Commercial clarity: risk-informed suitability assessment to support sponsor decision-making.
- ✓Risk-rated findings with practical remediation roadmap
- ✓Findings that your stakeholders (sponsors, compliance teams) can trust
2–4 weeks
For Investigator Sites & Research Institutions
Your Challenge:
Sponsors are increasingly rigorous in site qualification.
You understand GCP in your context, but may have gaps that matter to external auditors.
You want to close issues before sponsor audits arrive—on your terms, not under pressure.
- ✓Pre-sponsor-audit assessment (know where you stand first)
- ✓Partnership approach: we help you demonstrate capability, not find blame
- ✓CAPA support that’s proportionate to your environment
- ✓Training so your team can explain decisions under inspection
- ✓Documentation package that satisfies sponsor confidence requirements
2–3 weeks
For Good Clinical Laboratory Practice (GCLP) Compliance
Your Challenge:
Your laboratory operates in accordance with both TGA and NATA expectations.
Clinical trial results depend on your data integrity and system controls.
You need independent verification that your systems meet regulatory expectations.
- ✓GCLP system design and operational procedures
- ✓Computerised system validation (LIMS, analytical equipment)
- ✓Data integrity and audit trail controls
- ✓Equipment calibration and maintenance records
- ✓Staff competency and training documentation
2–3 weeks
For Pharmacy & Clinical Manufacturing Operations
Your Challenge:
Clinical supply chains are heavily scrutinised during sponsor audits.
You understand pharmacy operations but may have gaps in clinical trial-specific requirements (randomisation integration, pharmacy CAPA coordination with sponsor).
Documentation may not meet TGA expectations.
- ✓Clinical pharmacy operations audit (compounding, QMS, procedures)
- ✓Storage, handling, labeling & distribution compliance
- ✓ Randomisation & supply chain integration assessment
- ✓Pharmacy-specific CAPA framework aligned to sponsor expectations
- ✓Distribution network vendor qualification
2–4 weeks
For Data Management & Computerised System Validation
Your Challenge:
Your systems may lack proper validation documentation (IQ/OQ/PQ).
Audit trails, access controls, and change management may not be ready.
You’re unsure whether your data systems would withstand regulatory review.
- ✓Data integrity gap analysis (ALCOA+ assessment)
- ✓System validation review (IQ/OQ/PQ documentation)
- ✓Audit trail & access control assessment
- ✓Change control & deviation management procedures
- ✓Remediation or validation roadmap
2–4 weeks
For Clinical Manufacturing, Labeling & Distribution
Your Challenge:
Clinical manufacturing must meet TGA expectations.
You need confidence that vendors maintain quality and traceability.
Documentation (batch records, labelling, distribution tracking) must be available.
You’re unsure if your manufacturing vendor is truly compliant.
- ✓Manufacturing & labelling operations audit (quality systems, procedures, records)
- ✓Vendor qualification assessment (capability, controls, compliance history)
- ✓Batch record & traceability review
- ✓Labeling controls & product release procedures
- ✓Risk-rated findings with remediation roadmap
2–4 weeks
For Clinical Trial Pharmacovigilance & Safety Reporting
Your Challenge:
GCP inspections scrutinise:
— Timeliness of expedited reporting (SUSARs, SAEs, IND safety reports)
— Case narrative quality and completeness of medical review
— Safety database accuracy and reconciliation with EDC data
— Sponsor-investigator communication and safety oversight documentation
- ✓Safety case processing workflow audit (intake → assessment → reporting)
- ✓Safety database quality and reconciliation review (Argus, Oracle, ARISg, etc.)
- ✓Expedited reporting timelines and regulatory compliance (SUSAR, SAE reporting)
- ✓Medical review quality assessment (causality, expectedness, severity grading)
- ✓Sponsor-investigator communication procedures and oversight documentation
- ✓Safety oversight committee documentation (DSMB, Safety Review Committee)
- ✓CAPA development for gaps identified during audit
2–4 weeks
How We Operate
- Initial Contact: Capability / Experience Brochure (provided)
- Intro Meeting (30 minutes): Confirm need, context, and constraints
- NDA / CDA: Executed before sensitive information exchange
- Audit Scoping Form: Completed by client (sites, services, systems, timelines)
- Costing & Scheduling: Cost estimation, standard clauses, and availability provided
- Proceed Decision: If “Yes” → Proposal / Agreement issued and signed
- Audit Date Coordination: Liaise with auditee/vendor; confirm with client
- Audit Agenda Finalised: Locked 2 weeks before onsite audits; 2.5–3 weeks for remote or complex audits
- Document Request: Issued via secure platform 1 week prior (remote/complex audits may require earlier staging)
- Audit Delivery: Virtual or onsite audit conducted
- On-the-Day Close-Out: Tentative findings and observations discussed
- Draft Audit Report: Issued within 10 working days
- Auditee Review: Factual accuracy review typically 5–10 working days after draft issuance
- Final Audit Report: Issued with findings, observations, and recommendations
- CAPA Follow-Up (Client-dependent): Client-led ownership, with optional support tiers if requested
- Tier 1: CAPA Plan Review (desktop review + comments)
- Tier 2: CAPA Plan + Monitoring (checkpoints + evidence review)
- Tier 3: Effectiveness Verification (desktop or re-audit verification)
Regulatory alignment:
Aligned to ICH E6(R3) and consistent with MHRA GPvP and EMA GVP expectations.
Common Delays to Timeline
- Auditee provides insufficient information prior to or during the audit
- Auditee inexperience with audits (slower coordination, incomplete evidence, delayed responses)
Carl Bufe — Independent GxP Auditor & Pharmacist
Carl Bufe is an independent GxP auditor, pharmacist, and regulatory practitioner with over 24 years of experience across pharmacovigilance, clinical research, quality systems, and healthcare operations.
He audits across GCP, GVP, GLP, GMP, GDP, Data Management and AI-enabled systems.
- Pharmacovigilance and Data Management
- GCP and vendor qualification audits
- Due diligence audits for international sponsors
- AI-enabled and computerised system audits
- Bachelor of Pharmacy (Hons)
- Postgraduate Diploma in Quality Systems
- Bachelor of Commerce (Risk & Finance)
- ISO Lead Auditor (ISO 9001, ISO 13485, ISO/IEC 42001)
- Certificate in Computer System Validation
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