Why a Pharmacovigilance Quality System That Looks Compliant Can Still Fail Inspection

A quality system can look spotless on paper and still fall apart the second an inspector starts asking real questions.

Dr. Marcela Fialova, our Co-Founder and COO, sat down with Lucia Matejkinova, our QA Director, to talk about the three things that actually decide whether a pharmacovigilance quality system holds up: how to think about deviations, what makes a corrective action real instead of a box-ticking exercise, and which KPIs are actually worth watching.

Looking compliant and being compliant are not the same thing. This one gets into the difference.

Got a pharmacovigilance question of your own? Put it to our experts: https://ivigee.com/#question

By Gemma Dailly

Marketing Director

Gemma Dailly is Marketing Director at iVigee and a seasoned marketing professional with extensive experience across clinical research and healthcare technology. Having held senior marketing roles at CluePoints and AARDEX Group, she specialises in building high-growth brands, developing strategic marketing programmes, and turning complex industry challenges into compelling stories that resonate with customers and stakeholders alike.

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