Challenging times require creative solutions. Especially now, when in-person contact is discouraged yet first-hand, observed information is critical, we all depend on fresh ways to think about how we provide access and insight.
Because travel restrictions due to the ongoing global coronavirus pandemic have made in-person audits extremely difficult, if not impossible, for our clients to conduct, Aldevron clients now have the option to complete facility audits virtually rather than in person.
Aldevron is pioneering a new standard for the contract manufacturing industry through our offering of a system like this. We are proud to be at the forefront of meeting clients’ needs in these current and changing circumstances.
Now, our clients can complete audits from the security of their home offices, from anywhere in the world.
The Aldevron system comprises all the elements of an onsite audit, including a virtual tour of the facility which is tailored for what would have been observed during onsite audits via high definition videos, a detailed review of all requested documentation and paperwork, and a review of manufacturing processes and procedures through batch record reviews.
This is not a scaled down version of a traditional onsite audit. The virtual audits still involve a meeting between our quality team and clients’ staffs, easily conducted via video conferencing.
From documents requested in advance while planning the audit, to an interactive tour of our facilities, to meeting with Aldevron personnel, every element of the virtual audit has been reimagined, providing maximum familiarity with our procedures and methods.
Facility audits are generally completed by clients at the beginning of our working relationship and at intervals we agree to in the governing quality agreement. They’re integral to proving our capabilities and the quality of our equipment and processes, and to helping us establish and maintain trust with our clients.
In addition to providing clients a viable alternative to in-person audits, virtual audits help Aldevron limit the number of visitors to our facility, which in turn reduces the risk of coronavirus exposure among our clients and employees and to the facility itself.
At Aldevron, our objective is always to make clients feel comfortable with what we do and how we do it. The results meet or exceed all Food and Drug Administration requirements and Chemistry, Manufacturing, and Controls guidelines, even when clients can’t be onsite. That goal drove the development of our virtual process, which supports and encompasses the cGMP and GMP-Source® service levels.
The system is already up and running. Several clients have completed online audits, which we implemented in early July, and their feedback has been overwhelmingly positive.