Strengthening Inspection Readiness Through Proactive Reviews

About this session

Part of Session 6, Track D: Risk Based Approaches (Chair: Donna Dorozinsky, Just in Time GCP).

Is your eTMF truly inspection-ready, or are you waiting for issues to surface before taking action? Much like routine health checkups, eTMF Health Assessments offer a proactive approach to maintaining quality, identifying risks early, and ensuring ongoing compliance throughout the study lifecycle.
In this session, we'll explore how regular, risk-based reviews can drive deeper, targeted assessments, using data and insights to prioritize high-risk areas and focus resources where they matter most. Through structured reviews and trend-based insights, attendees will learn how Health Assessments provide meaningful metrics on timeliness, quality, and completeness, enabling teams to identify early warning signs before they impact study milestones or inspection readiness.
By shifting from reactive remediation to continuous oversight, organizations can strengthen inspection readiness, reduce rework, and embed sustainable quality practices into their processes. Moving beyond a reactive mindset makes compliance a built-in foundation that supports long-term success.

Speakers

• CR

  Carol Radwanski

  Just in Time GCP

  Speaker

• JS

  Jenn Stamper

  Just in Time GCP

  Speaker