Inspection Readiness for Device Use in Trials
Be audit-ready — every file, every record, every time.
AuditPrep prepares device-related documentation, processes, and data for regulatory authority, sponsor, or ethics committee inspection.
Why it matters:
Incomplete device files or untracked changes can result in FDA 483s, trial holds, or reputational damage.
Our services include:
Mock audits & CAPA remediation
Study-specific audit binders (CE, DoC, UDI, IFU, SOPs)
FSCA/recall documentation & response planning
Multi-agency inspection support (FDA, EMA, MHRA, PMDA, NMPA)
Compliance built in:
Aligned with GCP, ISO 13485, 21 CFR Part 11, and relevant vigilance reporting requirements.