Definition

The broader systematic activities that ensure pharmacovigilance processes are performed according to established standards and regulations.

Example

QA conducts periodic audits of the case processing workflow, reviews compliance metrics, and ensures SOPs are current and followed consistently.

Regulatory source

EU GVP Module I

Common mistakes

Confusing QA with QC. QC is case-level review; QA is system-level oversight ensuring processes are adequate.

Inspector question

How does your QA function oversee pharmacovigilance activities? What KPIs do you monitor?

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