Audit support, documentation collection and preparation, internal audit, mock interviews. Their Russian affiliate faced an urgent internal audit inspection.

Expert support delivered.

Client type.

Biotechnology.

Geography.

USA.

Lifecycle stage.

Post-marketing.

Service area.

Quality Management.

Summary

  • Audit support, documentation collection and preparation, internal audit, mock interviews.

  • Their Russian affiliate faced an urgent internal audit inspection.

Challenges

Timeline. Arriello received the request for help with just one week before the audit. We had little time to ready the affiliate, or collaborate with its departments to prepare and share the extensive documentation list.

Experience. Our client’s affiliate had no prior experience with audits. In fact, this was the team’s first audit, and they didn’t know what to expect or how to prepare.

They lacked information on what documentation they needed, how the auditor would interview them, and what questions the auditor would ask.

Language. While our client’s affiliate was Russian, the auditor spoke English, further complicating the situation.

Solution

Through a series of teleconferences we gathered the agenda and the documentation the auditor required, including all records: trackers, standard operating procedures (SOP), contracts, program overviews, and curricula vitae (CV), formatted and organized in a cloud-based system to make them available to the auditor.

Two days before the audit we arrived in Russia and immediately prepared the client by querying the regulatory teams, medical affairs teams, and sales representatives with strategic mock interview questions based on our extensive knowledge of prior audits.

During the audit, we established fluent communication between the auditor and the affiliate, and assisted the organization with answers when needed.

Faster. Better. Smarter.

Our client achieved faster results thanks to Arriello’s proactive measures. We allocated resources and organized all pre-audit preparation well before the audit commenced. This provided the necessary time to review all the processes and make any changes so our client avoided mistakes before the final report.

Our results were also qualitatively better. Because we take a personal approach to client interactions, the affiliate gained an improved understanding of the audit process, preparing the team for questions the auditor would ask.

Another benefit of our better approach was the project’s organization and planning, helping the affiliate understand the agenda and become familiar with the audit process through mock interviews.

Finally, by partnering with Arriello, our client benefited from our smarter approach. When the request for help came, we didn’t panic at the one-week timeline. Instead, we leveraged the collective expertise of our team-sharing responsibilities to quickly meet our client’s objective.

Our faster, better, smarter approach empowered our client to turn a lack of preparation into a successful inspection outcome.

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