Challenge: Internal Audits No Longer Gave Peace of Mind

Top executives can delegate responsibilities to a quality system like auditing, but they cannot escape the accountability that falls back on their shoulders. Thus, third-party audits ensure that processes and procedures are rigorously vetted while giving executives the peace of mind they need to lead and grow their companies. 

A worldwide leader in biotechnology (henceforth referred to as the Client) recognized this truth, and reached out to its network for recommendations for third-party auditing organizations. They needed an auditing partner that could provide thorough analysis of its facilities, its manufacturers, and its critical suppliers. Due to QualityHub’s reputation for thorough audits and our longstanding cooperation with the FDA, QualityHub became the ideal partner for the Client. 

Approach: Wide scale, experienced auditing

At the start of the partnership, the Client worked with QualityHub to map out a network of locations — both internal and external to the company — that needed to be evaluated. We engaged our seasoned auditors to assess current workflows and identify potential compliance issues within the Client’s facilities. 

We then broadened the scope outward, looking next to critical suppliers. Our auditors conducted rigorous evaluations of worldwide manufacturing locations and to ensure all requirements were met for device protocols and development. QualityHub also evaluated the clients R&D sites for proper design controls, confirming that user requirements were met by the design to validate that the product met the intended needs of the end user. We also went to the Suppliers themselves for further evaluation.

These external audits took the QualityHub team across the country and around the world. Our auditing team includes a diverse range of native language speakers, including Spanish, German, and Mandarin. We understand that in order to effectively communicate with clients, having experienced multilingual auditing teams is critical to addressing issues. 

Results: Reliable risk management foundation

At QualityHub, we know that in order to manage risks, you must first understand the circumstances surrounding them. We equipped the Client with audits thorough enough to provide a robust foundation for risk management procedures moving forward. This provided the Client with assurance that they’re running as closely as possible to a state of compliance. 

One of the biggest results of the Client’s partnership is the insightful, comprehensive analysis of the company from a broad scale. This informs risk management policies and helps executives analyze areas for improvement without sacrificing compliance. By using QualityHub’s third party auditors to conduct  Internal Audits, , companies can avoid larger compliance issues like warning letters — and the complications that come with them.