Does a Mock Inspection Really Prove You’re Ready?
by: Paul DavidsonPublished on: 28/02/2026Mock inspections are standard practice in regulated clinical research. They create activity, generate findings, and offer reassurance. But do they truly test whether your organisation is inspection ready, or do they simply re-document weaknesses you already suspected? In this month’s lead article, Gill and I challenge a common assumption: that rehearsing an inspection equates to resilience. Drawing on current regulatory expectations under ICH E6(R3) and practical experience across clinical environments, she explores the difference between superficial compliance and system capability. The piece examines what inspectors actually notice in the first hours of an inspection, why scripted answers and over-functioning QA departments are warning signs, and how leadership behaviour often determines inspection outcomes more than documentation alone. If inspection readiness is meant to be a state, not a project, this article invites clinical leaders to ask a more demanding question: does your system withstand pressure, or does it simply perform well in rehearsal?
When Vendor Oversight Becomes Admin
by: Paul DavidsonPublished on: 28/02/2026Most GLP organisations would not describe their vendor oversight programme as administrative. And yet, many programmes quietly drift from risk mitigation into record keeping. In this month’s Industry Observations piece, Thomas explores how to recognise when oversight is generating superficial reassurance rather than protection. Are you measuring audit activity instead of risk reduction? Accepting CAPAs without testing effectiveness? Relying on annual audits as evidence of ongoing control? The article goes beyond process and into purpose. It examines how superficial oversight shows up during inspection, what it costs operationally and strategically, and how to reset without rewriting your procedures. If inspection readiness is genuinely embedded, vendor oversight should feel alive, proportionate, and risk-led. If it feels comfortable but passive, that may be the signal. Read the full article to test whether your oversight programme is reducing risk or simply producing evidence.
“It’s Just a Lab Test”… Until It Isn’t. What the MHRA webinar on IVDs really means for QA leaders and sponsors
by: Paul DavidsonPublished on: 28/02/2026When does “just a lab test” become a regulated IVD within a clinical trial? Following the recent MHRA webinar, we unpack what QA leaders and sponsors are genuinely struggling with: how routine safety labs, biomarker analyses and bespoke in-house assays fit into the current regulatory landscape. More importantly, we explore what this shift means for governance and inspection readiness. If a test result influences trial decisions, it is no longer background infrastructure. It is part of the regulated trial system. This article translates the technical guidance into practical questions you should be asking now, before an inspector does.
Validated… But Defensible? The Silent Risk in Your Digital Systems
by: Paul DavidsonPublished on: 28/02/2026Validated systems often create a sense of confidence. The documentation is complete, the signatures are in place, and periodic reviews are scheduled. On paper, everything appears compliant. But inspection readiness in a digital environment is not determined by whether validation occurred. It is determined by whether the system is governed. In this month’s Rethinking QA feature, we explore the gap between validation and defensibility. Why do inspectors focus more on change control, audit trail review and management oversight than on the size of your validation pack? What happens when operational leaders cannot clearly articulate digital risk? And how does routine compliance drift into ritual rather than meaningful control? Drawing on patterns seen across recent system reviews, this article challenges a common assumption: that validated equals ready. If you are confident in your digital systems, this piece will confirm it. If you feel a slight discomfort reading it, that may be the signal you need.
