Responding to Site Findings

Send us Fan Mail At first glance, responding to site-level findings seems simple—but when Edye and Darshan dug into the details, it became clear that the lines of responsibility blur fast. Here's how each side sees it: Site Perspective: Sites know the boots-on-the-ground reality. When a finding is made—especially during an external inspection like the FDA—they’re often the ones best positioned to analyze what went wrong. The site team (usually led by QA or compliance professionals) need...