At ARIREX, we provide comprehensive auditing services designed to ensure your organization adheres to GxP (GMP, GCP, GLP, GVP) standards. Our independent assessments help you identify gaps, mitigate risks, and enhance the overall quality and compliance of your operations.
Whether you are preparing for a regulatory inspection or need to verify the compliance of your supply chain, our experienced auditors deliver detailed, actionable insights. We cover a wide range of auditing needs, from internal system audits to external supplier qualification.
Key Audit Capabilities
Our auditing methodology is rigorous and risk-based, ensuring that we focus on the areas most critical to product quality and patient safety.
- Internal Audits & Self-Inspections.
- Supplier & Vendor Qualification Audits.
- Mock Regulatory Inspections (FDA, EMA, TGA).
- Good Clinical Practice (GCP) Investigator Site Audits.
- For-Cause and Due Diligence Audits.
Benefits of Our Auditing Services
Partnering with ARIREX for your auditing needs brings expertise and objectivity to your quality management strategy.
- Inspection Readiness: Be prepared for regulatory agency visits with identified and remediated gaps.
- Risk Reduction: Proactively identify non-compliance issues before they become critical failures.
- Supplier Assurance: Ensure your vendors meet your quality standards and regulatory requirements.