Definition

The percentage of regulatory submissions completed within required timeframes, a key indicator of pharmacovigilance operational performance.

Example

Of 100 expedited reports due this quarter, 98 were submitted on time, yielding a 98% compliance rate. The 2 late submissions are investigated for root cause.

Regulatory source

EU GVP Module I, FDA Compliance

Common mistakes

Celebrating high compliance rates without investigating the late submissions, which may indicate systemic issues.

Inspector question

What is your expedited reporting compliance rate? How do you investigate and address late submissions?

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