04 · GxP · GAMP 5 · MES

Validation and interim project leadership

How do we prove to the inspector that the system reliably does what it should in our environment?

What I hear

The system is meant to go live, but validation is turning into a mountain of paper.

What I do
  • Qualification in the V-model under GAMP 5, traceable from requirement to test case
  • Data integrity under ALCOA+
  • Operational coordination of implementations, rollouts and revalidations
What lands on your desk
  • Validation plan
  • URS
  • Traceability matrix
  • Data integrity gap report
  • Validation report
How you notice it
You steer changes to your systems quickly and under control, because it is clear what needs testing and how deeply.

What is necessary in your case?

In 30 minutes you will know where you stand and what the next sensible step is.

Book an initial call