Equipment qualification and process validation are one of the top 3 topics during an FDA inspection.
With great experience we develop concepts for qualification and validation complying with regulations and of maximum benefit for the company. Furthermore, we are aware of the internal requirements of the big players in the market. We can thus offer reports that are bulletproof in audit situations and at the same time fulfill customer requirements.
We establish processes together with our customers and either actively execute them or coach the responsible staff by passing on our knowledge.