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
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Let's make your project
audit-proof.

Your project deserves a validation that accelerates go-live — not blocks it. Benefit from the assurance of 60+ successful projects.

60+
Projects
15+
Years
100 %
Audit-Pass
0
Findings
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