Internal Quality Audit

Quality management and compliance

US Global Biotechnology Firm  
Est: 1992  Size: 2,400

Arriello Russian Audit Header Image 2

Project: Enabling a Russian-based biotech affiliate to rapidly prepare and successfully pass an internal audit.
Summary: Audit support, documentation collection and preparation, internal audit, mock interviews.

A US-based biotechnology firm with a global reach contacted Arriello with a pressing problem. Their Russian affiliate faced an urgent internal audit inspection. While successfully passing an audit is inherently difficult, this project involved a complication that made the task especially challenging.

Challenges

There were three big challenges for our client.

Timeline. Arriello received the request for help with only one week left until the audit began. We had little time to ready the affiliate...or collaborate with its departments to prepare the extensive list of required documentation and share these with the auditor.

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. Further complicating the situation was a language barrier. While our client’s affiliate was Russian, the auditor spoke English.

Despite these combined challenges, Arriello was still able to execute a faster, better, smarter solution on our client’s behalf.

Solution

Acting quickly, we launched a series of teleconferences with the affiliate to discuss the agenda and the documentation the auditor required.

For each department, we gathered all records: trackers, standard operating procedures (SOPs), contracts, program overviews, and curricula vitarum (CVs). After formatting and organizing them, we used a cloud-based system to make these critical documents available to the auditor.

Two days before the audit we arrived in Russia to provide further face to face support. Immediately, we prepared the client by querying the regulatory teams, medical affairs teams, and sales representatives with strategic mock interview questions. To make these interviews realistic, we used questions based on our extensive knowledge of prior audits.

Throughout the audit, Arriello continued to offer help and expertise. We established fluent communication between the auditor and the affiliate, and we also assisted the organization with answers when it didn’t know how to respond to the auditor.

Faster. Better. Smarter.

Empowered by Arriello’s faster, better, smarter approach, our client successfully passed the audit—with no critical findings.

Our client achieved fast results thanks to Arriello’s proactive measures. We were 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. However, our results weren’t simply fast...they were also qualitatively better. Because we take a personal approach to client interactions, the affiliate gained an improved understanding of the audit process. In turn, this prepared the team for questions the auditor would ask.

Another benefit of our better approach was the project’s organization and planning...these skills helped the affiliate understand the agenda and become familiar with the audit process through mock interviews. In addition, our communication skills allowed us to adapt our approach to the affiliate's culture...which helped focus our energy on preparing the team without struggling with cultural barriers.

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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