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Virtually Achieving Quality Assurance Audits

· Discuss the importance of supporting customer audits during these challenging times

In our industry where product quality and patient safety are the priority, Quotient recognizes the importance of building trust with our customers. One way we build this trust is through our transparency and by providing our customers with opportunities for them to have oversight of what we deliver.   We recognize this need has not changed despite the current climate where public health issues are preventing face to face visits. At Quotient we have adapted to the current circumstances to ensure that despite the restrictions on travel, we could offer a virtual service that was commensurate in detail and quality, we can ensure that we maintained  customer trust and support their ability to satisfy their supplier management program requirements.

· How has Quotient adapted to be able to host virtual QA audits?

Quotient’s Quality Assurance (QA) and IT teams worked together to develop a virtual audit process leveraging the best available technology. A designated customer hub is created within a file share service to share requested documentation before and during the audit.  Microsoft Teams is used to manage the audit itself and conduct real-time face to face interviews, virtual tours, and screen share of data systems or documents.  Other forms of communication, such as voice or video calls, can be supplemented during the audit in order to maximize communication between the auditors the Quotient audit host(s) and any required subject matter experts (SMEs).

· What does Quotient virtual audit include and what should customers expect?

A standard Quotient virtual audit will take place over 1 to 2 days, depending on scope. A pre-audit meeting is held in the weeks prior to the audit to ensure that the auditor is familiar with the IT systems, the virtual audit approach, and to finalize the strategy for satisfying all agenda items. The designated customer hub will be created within the file-share system 1 – 2 days in advance of audit to ensure that there are no technical issues on either side which may impact audit execution. Pre-requested documentation can be shared in advance to ensure the auditor is familiar with Quotient’s operating framework (e.g. list of SOPs, organizational charts, copies of licenses, etc.).

· How do virtual audits compare to in-person audits?  (benefits and disadvantages)

While virtual working will never fully replace the need for live interaction, Quotient has been able to deliver equivalent quality between onsite and virtual audits. We can readily and easily share documentation, arrange virtual face to face interviews and facility tours *. A dedicated audit host(s) is available before, during and after audit to address our customer’s needs. The most significant benefit shared by our customers as it relates to Quotient’s virtual audits is the ability to fulfill their requirements without the need for travel.  This not only helps them reduce their internal costs and improves efficiency, but also has a positive impact on our ecological and carbon footprint. 

*Due to legal requirements, virtual facility tours of the clinics in Nottingham and Miami may not be permissible due to consent requirements surrounding the broadcasting of our volunteers’ image. If these are unavailable, other media is used to showcase the layout of the clinical wards.

· How do regulatory bodies and government agencies view virtual audits?

Global regulatory authorities recognize the need to work flexibly and pragmatically, particularly during the current pandemic. Many of these regulatory authorities, including the MHRA and FDA, have introduced a virtual inspection program. Provided that supplier audit programs and associated requirements are being met and appropriately documented, virtual audits can be an effective compliment to on-site audits.

· Is there anything different that the customer needs to do on their end?

We want to reassure our customers that a virtual audit at Quotient will meet or exceed your needs. We have received praise from customers for our openness, timely access to information and ability to have valuable interviews with SMEs. We commit to our customers that they will be met with transparency throughout the audit experience. With respect to virtual tours, we also recognize that a customers do not have the same 360° view as with on-site audits, so we encourage our customers to drive the tour; our audit hosts can be your eyes and ears, and zoom in to any particular areas of interest during the tour.

For more information about our virtual audit capabilities or to schedule an audit, email info@quotientsciences.com.

 

 

 

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