What is inspection readiness?
Inspection readiness refers to the ability of an organization to operate at a level that allows for effective preparation for an inspection. Per ICH GCP guidelines, a TMF inspection focuses on the documents and records related to the clinical trial versus an audit that encompasses the activities related to the trial (Sec. 1.29, 1.6).
This fall showcased two eTMF-related conferences. We recently shared a post covering the key takeaways from these events in detail. Every attendee had a common mission – to continuously learn about how to keep a tidy and effective TMF, and learning tips and tricks from our fellow TMF enthusiasts. We are all part of a constantly growing, evolving, and passionate community, and that was never more palpable than while attending these events and listening to the discussions.
