As research continues through the COVID-19 pandemic, the need to continue operations as usual and manage critical timelines within regulatory compliance presents unprecedented challenges for the entire pharmaceutical industry. Due to the potential spread of COVID-19, the Alturas Quality Assurance Unit (QAU), working with Alturas’ IT, introduced the ability to conduct virtual audits. These audits include live web-based discussions, in-depth interactive facility tours and secure folder access for file sharing of controlled documents in strict adherence with Alturas SOPs.
Alturas’ QAU is taking additional in-house precautions to further conform to CDC recommendations. In-process critical phase audits of regulated studies are being conducted as scheduled while working within the recommended social distancing guidelines. To reduce opportunities of possible COVID-19 spread, the time spent with Alturas scientists during inspections and within the QAU group is minimized through working remotely and staggering work schedules.
Alturas’ QAU continues to address and implement comprehensive SOPs to provide structure and consistency for all operations of Alturas Analytics during the changing landscape of COVID-19. While Alturas remains open as an essential business, the QAU ensures that pre-clinical and clinical study activities are conducted in compliance with procedures and applicable regulations on schedule.