GCP Auditing

At Beaufort, thorough preparation and meticulous follow-through are key to the way we approach every project. This attention to detail is evident in our auditing services, where diligence is a critical asset. Our people have a complete understanding of all facets of clinical trials and activities, including where shortcomings in quality can arise. We leverage that understanding to perform complete auditing services inside and outside of your organization.

Beaufort will conduct mock regulatory and GxP compliance audits and provide employee training to ensure your organization is inspection-ready. We know what regulatory agencies will look for and how you can best accommodate and facilitate reviews and inspections, thus avoiding delays. On a site level, we will inspect facilities, processes, training compliance, protocol-adherence and more. Beaufort will also help you evaluate current and potential vendors to ensure your research integrity regardless of where it is being conducted.

We Provide:

  • Vendor audits, including CROs
  • FDA quality system inspection techniques (QSIT)
  • All CFR requirements
  • GCP audits
  • External supply chain audits of vendors
  • Pharmacovigilance