Definition

The documented process of demonstrating that a computerized system (e.g., safety database) consistently performs according to specifications and regulatory requirements.

Example

Before deploying a new safety database, validation testing confirms that E2B exports are correctly formatted, audit trails capture all changes, and calculations (like time to onset) are accurate.

Regulatory source

21 CFR Part 11, EU GMP Annex 11

Common mistakes

Completing initial validation but not maintaining validated state through change control and periodic review.

Inspector question

Is your safety database validated? Show me your validation documentation and change control records.

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