Free playbook · GAMP 5 2nd Edition · FDA CSA

The CSV Execution Playbook, the test templates and risk matrices we run in our own projects.

Risk-based, not script-volume-driven.

A practical playbook along GAMP 5 (2nd Edition) and FDA CSA: how we run validation execution, Integration, Validation and Execution in one flow, so a go-live lands on time, in budget and without findings. With the test templates and risk matrices we use ourselves.

  • IVE, Integrated Validation Execution , Application, Compliance and Business stream in sync from day one.
  • Risk matrices + test templates , Critical Thinking per GAMP 5 2nd Edition, ready to adapt.
  • 3–9 months for a SAP-class system , versus the 12–18 months common in the industry.
60+ validated systems 100 % audit pass rate 0 critical findings
Free material by email

Get the material by email — free.

Name and email are enough — we send the PDF straight to your inbox, with a short personal note from Daniel.

The next step takes 15 minutes.

Click the button, choose a phone slot, and we talk briefly and honestly about your situation. Free of charge, and it commits you to nothing more.

60+
validated systems
17+
years of practice
100 %
audit pass rate
0
critical findings
Arrange your free initial consultation

15 minutes · by phone · no pitch