Does your organization rely on metrics reported by your eTMF to assess the “health” or “completeness” of your TMF? How reliable are the measures? What do these metrics really tell you about the quality of your eTMF? What about other important documentation not filed in the eTMF — how do you assess whether non-eTMF components of your TMF are inspection ready? These questions and others will be explored in this “hands-on” inspection readiness metrics workshop. During the workshop, participants will learn how to use a metric development framework to define metrics that help answer important key inspection readiness questions identified by workshop participants. Come “roll up your sleeves” and work with your peers to identify metrics that your organization should be measuring to answer key questions about inspection readiness.