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,
- Impact negatively on the organisation’s, regulation.
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.
Download your copy today:
23 Mar, 2022
eBook: An eTMF Archiving and Preservation Guide – Revised for 2022
07 Dec, 2022
Webinar Recording: Examining the data retention requirements of EU Reg 536/2014
09 Nov, 2022