Different functions, same mistake: a decision gap across GLP, GCP, and CSV
by: Paul DavidsonPublished on: 31/03/2026Across preclinical, clinical, and CSV environments, the same pattern repeats: vendors are often chosen before the real decision is openly discussed, leaving audits to confirm rather than influence the outcome. This article explores how that decision gap shows up in different forms depending on where you sit, from mid-study audits in preclinical work to overlooked laboratory risk in clinical trials and late-stage vendor qualification in CSV. Rather than focusing on process failures, it reframes the issue as a gap in how and when decisions are made, and offers simple ways to recognise and shift this dynamic in practice. The aim is not to add complexity, but to help organisations regain control of the moment where risk is truly decided.
Validation Beyond Regulation: A Smart Business Investment
by: Thomas StevensonPublished on: 27/10/2025This month, the Headway team revisited what validation really means - and discovered it’s not about regulation at all. It’s about trust. We share a client story where applying validation principles to a non-regulated system built cross-functional confidence, reduced risk, and clarified ownership. As digital tools multiply, validation isn’t bureaucracy - it’s good business.
