Introduction

The prospect of regulatory inspection is often sufficient to send adrenaline pulsing through the veins of anyone involved in clinical research. Poor inspection outcomes can lead to observations and findings that may interrupt or delay research progress, increase regulatory monitoring, lead to product recall, result in the non-approval of a drug, trigger fines for non-compliance, or even impact negatively on the organisation’s reputation. Organisations should not wait to be notified before preparing for an inspection but adopt inspection readiness as a continual state of being, not regard it as a one-time event.

Adopting a “quality by design” culture of compliance for all regulated activities can equip an organisation with the confidence to pass inspections.

This eBook aims to guide your preparation and planning for inspections, specifically from the perspective of data integrity.