A Research Site's FDA Inspection with eRegulatory
For clinical research sites, FDA inspections are inevitable. As more sites are adopting eRegulatory to manage study documents and electronic signatures, real-world experience on the audit process has been limited - until now.
A new case study from Complion shares insights into Chesapeake Research Group's (CRG) FDA inspection while using the Complion eRegulatory system.
Access this case study to gain insight into the FDA inspection process, including:
- Steps taken prior to the inspection, including site SOPs and document access considerations
- Considerations driven by the differences between a paper-based system and eRegulatory
- Impact from transitioning to eSignatures and electronic Delegation of Authority (DOA)
- Comments and reactions from the FDA inspector
- Inspection outcomes and final reflections from CRG