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Full Team for Audit Management

 
INDUSTRY
Biopharmaceutical
SERVICES
GmP/GcP/GlP Supplier Audits
Internal Audits
SKILLS
GmP/GcP/GlP Auditing
FDA Readiness
Six auditors available throughout the year to support remote and on-site audits.
The Challenge

A research-based biopharmaceutical company was creating its annual audit plan and recognized the need to partner with an external vendor to support supplier audits. In addition, their internal team was not robust enough to handle the volume and felt external auditors could provide a more objective review for qualification and requalification needs. 

The Solution

The Oxford team listened carefully to the client’s requirements and used our background in auditing to help them build a “bench” of auditors that would be available throughout the year to support both remote and on-site audits. Oxford presented candidates who had worked with us in the past and an expectation for cost per audit, which allowed us to build a strong team of six auditors and expectations for the budget. The account manager hosted weekly calls with the client’s internal team to ensure all parties stayed cohesive. For each audit, the auditors completed the following activities:

  • Coordination with external vendors to schedule audits and create agendas
  • On-site or remote visit to the facility with thorough review, documentation, and inspection activities
  • Final detailed report of findings

The Oxford consultants provided unbiased perspectives of external vendors while also freeing up bandwidth for the internal teams.

The Result

At the onset of the project, the client had a well-planned audit proposal for the year. However, early in the year, the COVID-19 pandemic began, and their entire focus shifted along with the option of being on-site for much of what had been pre-planned. Oxford was able to work closely with the client and auditing team to make this a seamless transition and ensure all required audits were performed safely and remotely. In our first year of support, we managed over 100 GmP, GcP, GlP, and internal audits for the client.