Virtual Site Audits Should Be The New Standard

By Jeannie Metzinger, Chief Compliance and Quality Officer, PCI Pharma Services

originally published in Contract Pharma

Getting life-changing therapies into patients’ hands is a complex process. At PCI Pharma Services, we look to provide answers and guide our clients across the drug supply chain ecosystem, anticipating and removing hurdles to ensure the best possible outcome. One of the biggest unexpected hurdles we’ve faced to date is COVID-19. It presented some unique challenges as we, like so many others, had to adjust to doing business in a virtual/digital world because of the new normal.

Yet, the pandemic also gave us an opportunity to be innovative problem solvers, which is what we do best. Beyond urgent issues like getting life-saving medications into countries before their borders closed, the pandemic prompted us to re-examine the ways we work—including the way we conduct our audits. Though all of our sites had the capability to conduct virtual audits and inspections, it wasn’t something we did because there was never a need. Yet, to keep life-saving drug launches on track, we had to start doing virtual site audits for the first time—and discovered an excellent business model in the process.