CSV, CSA & Data Integrity - done properly.
Experience across global pharmaceutical and regulated manufacturing environments including GSK and Viatris.
We build sustainable CSV/CSA/DI capability for pharma and life sciences teams, so you pass inspections and avoid rework, downtime, and fragile systems.
We help pharmaceutical organisations deliver GxP systems that remain controlled, rebuildable and defensible under inspection.
- Less validation theatre
- Fewer surprises at go-live
- Systems that can be rebuilt, recovered and defended under inspection.
If you’re implementing new systems, rescuing a failing project, or building long-term compliance capability, we’ll help you get it right the first time.
Meet Jonathan Bunker
25+ years delivering Computerised Systems Validation and Data Integrity outcomes across global pharmaceutical organisations including GSK and Viatris.
Specialising in risk-based CSV, CSA implementation and recovery of failing GxP systems.
Jonathan is typically engaged to provide independent CSV and Data Integrity leadership where delivery risk, inspection exposure or system complexity exceeds internal capability.
When things go wrong...
Most validation projects do not fail because of documentation.
They fail because systems are poorly understood, interfaces are unclear, and configuration decisions cannot be defended under inspection.
Validated Systems is often engaged when:
- projects are already struggling
- inspection confidence is low
- systems cannot be rebuilt or recovered
- validation has become performative rather than effective
We help organisations restore control and deliver stable systems that remain long after go-live.
