Establishing A Culture Of Inspection Readiness

By Alison Hussein, Senior Project Manager, Trial Interactive & Co-Authored By: Sean Momtahen, Product Marketing Operations Specialist, Trial Interactive

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).

The level to which an organization deems they are inspection ready is somewhat subjective. Generally speaking, the less time it takes to prepare, the more inspection ready you are considered. Real-time inspection readiness refers to maintaining the quality of inspection readiness with no preparation needed. The latter is a more literal definition, and the closer an organization is to real-time, the easier it is for them to be inspection ready.

Inspection readiness is not simply something you do; it is a state of operation. It is optimal good clinical practice and an ongoing organizational discipline.

An organization cannot achieve the highest levels of inspection readiness without a full, turnkey approach. Here are a handful of processes that must be completed to establish a culture of inspection readiness.