GxP qualification and computerised system validation for life sciences and other regulated industries
Are you in control?
«21 CFR Part 11 has not changed since the days of the floppy disk. Technology has. Today's laboratories run on AI, cloud services, automation and connected systems. The regulation is the same. What it has to govern is not.»
VALIDATION IS PROTECTION
Protection through systems, processes and data
You can’t control what you don’t understand.
Control begins with understanding the process: what the system must do, where data are created and what can go wrong. In GxP-regulated environments we qualify equipment, IT infrastructure and interfaces, and validate computerised systems, automated workflows and data transfers, from requirements definition to ongoing compliance.
We’re scientists and engineers, so we know the technical requirements and what inspectors look for. No templates, no assumptions: validation built on your systems and your processes. The result is more than a set of records. It is a process you control, because you understand it.
FROM PROCESS TO CONTROL
Our Services
Validation is not a single task. It means establishing control over your systems, processes and data, then keeping that control as they change. We do this across three areas.