Between travel limits and social distancing, in-person visits at testing sites for drug and medical device development are currently not an option. Qualifying testing sites is a standard industry practice, but the resulting restrictions of COVID-19 present new challenges that impact travel, available budgets and present time limitations in conducting qualification procedures. The responsibility to deliver lifesaving pharmaceuticals and medical devices remain, and WuXi AppTec is pivoting our efforts to ensure that our customers can continue moving forward during these uncertain times.
Performing a thorough audit on a new partner is important to ensure that they have the necessary capabilities and a competent team to support your projects, such as the development of an Investigational New Drug (IND). The auditing process can be extensive and exhaustive, requiring the full dedication of typically two or three in-person business days, in addition to travel. With current events throwing a wrench into how most of us regularly operate, WuXi AppTec now offers a virtual auditing process. This process is still in line with the recent discussions by the Society of Quality Assurance (SQA) and allows our customers to complete audits from the comfort of their own homes. Approaching an audit in a virtual format is an ideal way to accommodate any of your team’s restrictions, while still achieving the desired timeline.
From set up to Standard Operations Procedure (SOP) review, conducting audits virtually is more streamlined than one might expect and it presents advantages to both parties. For companies driving the qualification, this process is more convenient as it reduces travel, requires less scheduled lead time which can expedite an audit’s turnaround, and the learning curve is extremely approachable. While it does increase the importance of a lead quality assurance role with managing video conferences with the site’s experts, early collaboration and active communication can ensure they have your requests in advance and understand your expectations.
In the current climate, our clients’ needs are changing and we are eager to find new ways to support them. Offering virtual audits as an alternative has allowed our clients to continue making progress. Our goal is to go above and beyond in meeting customer needs, despite challenging times, and to make the process as turnkey as possible. For example, we’ve established a portal to share important documents directly, starting with SOPs, to provide accessibility. No matter where our customers are in the world, we will make our best effort to adjust our schedule to accommodate their normal business hours.
While qualification requirements vary from company to company, WuXi AppTec is willing and ready to forge a new path customized to your needs. If you have further questions, please let us know how we can help.
WuXi AppTec provides a portfolio of R&D and manufacturing services that enable companies in the pharmaceutical, biotech and medical device industries worldwide to advance discoveries and deliver groundbreaking treatments to patients.