In the clinical research industry, approvals for investigational products are not granted- they are earned. Increasing numbers of FDA early-intervention and routine inspections can increase the stress levels of everyone involved in clinical trials. Auditing can be looked at as a quality assurance process, and a way to prepare for inspections and approval by:
- Identifying and addressing issues before the FDA finds them.
- Preparing for Inspections by reviewing the BIMO checklists and knowing what to expect.
- Proactively addressing compliance concerns through BIMO preparation audits.
- Verifying that vendors are qualified to do their jobs.
- Preparing the research team with mock inspections along with interviewing and coaching sessions.
Topics: Voluntary Audits, FDA, Medical Device Single Audit Plan, Routine Inspection Plan