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GxP Audit Program Management.

Beyond your expectations.

Our pool of independent auditors are experts in GVP, GCP, MI, Regulatory and PV/QMS IT systems. Our team is headed by a trained GVP, GCP, MI auditor with over 16yrs experience. We have the global reach to manage the breadth of your Audit Universe across all levels of services.

When an audit is conducted by an Arriello auditor, you can be assured that your organization will receive a set of clearly identified next steps. We believe that auditing should be a training exercise, allowing your organization, or that of your vendor/partners, to feel that they have learnt through the experience.

We’ll meet all your auditing needs.

Our comprehensive audit outsourcing program offers the following options:

  • Risk benchmarking of partner/vendors not previously audited.
  • Strategic report writing.
  • Access to Arriello’s pool of international auditors.
  • Access to Arriello’s audit templates.
  • Access to Arriello’s remote auditing feasibility checklist for a seamless auditing approach.
  • Access to Arriello’s vendor management package within your audit program (further information available upon request).
  • Full guidance from our expert Auditing and QA consultants.

The Arriello guide to pharmacovigilance audit success.

When EU legislation on pharmacovigilance came into force in July 2012, it established the clear legal requirement that marketing authorisation holders must perform audits of their pharmacovigilance systems, including risk-based audits of their quality systems.

So why then are so many life sciences companies struggling with associated audits and inspections?

 

We’ve created a free to download guide that summarizes the 10 aspects of PV covered by the formal requirements, where companies are falling short and where they need to focus their attention to stay on the right side of inspectors.

 

Download our PV Audit Success guide…