The moment that defines your vendor risk (and it’s not the audit)
by: Paul DavidsonPublished on: 31/03/2026Most organisations believe vendor risk is managed through audits, but in reality the level of risk is often locked in much earlier, before QA is even involved. Across preclinical, clinical, and CSV environments, a consistent pattern is emerging: vendors are selected under operational pressure, and audits are carried out later as a formality rather than a true decision point. At that stage, the question is no longer whether the vendor is appropriate, but how to make the situation work. This article challenges the assumption that audits are a control mechanism and reframes them as feedback on decisions that have already been made. It introduces the idea that vendor oversight is fundamentally a decision-making problem, not an auditing problem, and sets the stage for exploring how organisations can take a more deliberate, risk-based approach to choosing when and how they assess their vendors.
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.
