Three ways to trust a vendor… and the risk you accept with each
by: Paul DavidsonPublished on: 31/03/2026Most vendor oversight strategies look robust on paper, but far fewer stand up to scrutiny when you examine when key decisions are actually made. This article explores the three common ways organisations build trust in their vendors, from pre-qualification audits to early in-study oversight, and challenges the assumption that these are simply operational choices. Instead, each approach reflects a different level of risk acceptance, often shaped more by timing, pressure, and internal dynamics than by deliberate design. Drawing on patterns seen across preclinical, clinical, and CSV environments, the piece questions whether audits are truly informing decisions or merely responding to them, and invites readers to reconsider how and when confidence in a vendor is really established.
The “low-risk” vendor that carries your highest exposure
by: Paul DavidsonPublished on: 31/03/2026Most organisations classify certain vendors as “low risk” because they sit outside core trial activity or are unlikely to be inspected. Laboratories, PK providers, and early-stage research partners often fall into this category. But the data they generate still shapes key decisions about whether a compound progresses or stops, and may ultimately feed into clinical development. Having asked QA professionals for years about the risks in this space, there is one answer that is consistently overlooked. This article explores that gap, highlighting the sponsor’s ongoing responsibility for data integrity regardless of regulatory scope. It challenges the assumption that limited oversight is justified and examines the less visible risks, including missed opportunities where promising compounds are abandoned based on unreliable data. It also outlines how a more proportionate, risk-based approach to oversight can be applied in practice, helping organisations build confidence in the data that underpins some of their most important decisions.
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.
What Regulators Look for When Organisations Are in Flux
by: Paul DavidsonPublished on: 30/01/2026Periods of organisational change are often when quality systems are most exposed. Drawing on decades of experience supporting regulatory inspections, this article explores what GxP regulators actually look for when organisations are in flux, whether that change involves new facilities, system migrations, or transitions from paper to electronic records. It examines why regulators expect instability, not perfection, and why the absence of a clear change plan, documented decision-making, and defined authority so often leads to avoidable findings. Using real, anonymised examples from inspections and audits, the article shows how well-managed change can become a quality advantage, providing confidence, traceability, and inspection-ready evidence rather than risk and rework.
