By Jill Healy
I recently attended the Inspection Readiness Summit in Philadelphia, PA this past week. The room was full with top level QA representatives from biotech/pharmaceutical companies and then there were only two CROs in attendance, Trial Runners being one. The Summit was amazing as we discussed risk mitigation strategies, work processes and inspection readiness preparations. We, the key attendees in the room, are the designers of these processes and fully understand the expectations. But we were missing just one thing: everybody else!
When it comes to quality, it’s not a process that can be created and mitigated without everyone’s buy in. This includes IRBs, sites, specialized vendors and regulatory departments. We all want to perform quality work, that’s the easy part, the hard part is everyone having the same definition of quality.
QMS = Quality Management System
This means your organization has to have a documented plan to oversee quality. If you don’t have a plan for the QMS – drop me a line, I would love to give you our tool that we use, free of charge. It’s easy to follow and adaptable for any organization.