Definition
EU GMP Annex 11 is European Union GMP guidance concerning computerised systems used in GMP-regulated activities.
Human Explanation
It explains how computerised systems supporting regulated work should be managed throughout their lifecycle.
Why it Matters
It supports confidence that systems affecting regulated processes and records remain controlled and fit for their intended use.
Conceptual Boundary
Annex 11 concerns the complete computerised system and its controlled use, not software alone.
Practical Perspective
Current expectations should be checked in the official Annex before defining Validation, change control, security or data-integrity activities.