By Laurie Wood
Improving Inspection Readiness Using Milestones and Expected Document Lists
TMF inspection readiness is measured by three factors: TMF completeness, quality, and timeliness. Historically, these metrics were difficult to track using paper-based TMFs. Even with electronic trial master files (eTMFs), tedious manual processes made inspection readiness challenging to assess in real-time. In response, two new features have been added in Veeva Vault eTMF: expected document lists (EDLs) and milestones.
One top-50 global pharmaceutical company has made EDLs and milestones integral to their TMF management approach. The company’s extensive experience can serve as a best practice guide in leveraging these capabilities to drive continuous TMF inspection readiness.