Feature|Articles|August 25, 2026

Inspection Readiness Is Not a Pre-Inspection Activity, It's an Execution Design Condition

Author(s)Elizabeth Walsh, PMP, ACRP-CP

Inspection readiness reflects how a program was actually run throughout its lifecycle, not what can be assembled at the end, making pre-submission remediation itself a signal of absent oversight rather than proof of it.

Inspection readiness is often understood as something that intensifies at the end. A pre-submission push. A final trial master file (TMF) review. A concentrated effort to confirm that everything is in order before an inspector arrives. For some organizations, it is the first time the question is asked with any urgency. That late urgency reveals the assumption behind it: that readiness can be assembled when it is needed. The review is sound practice. The assumption is not.

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