Prepare Inspection Readiness

Assess and improve organisational readiness for regulatory inspection, covering documentation, personnel preparation, logistics, and response planning.

When to Use

• A regulatory inspection has been announced or is anticipated
• Periodic self-assessment of inspection readiness is due
• New systems or processes have been implemented since the last inspection
• Industry trends (warning letters, 483s) indicate an emerging focus area
• After a significant audit finding that may attract regulatory attention

Inputs

• Required: Inspecting authority (FDA, EMA, MHRA, or other)
• Required: Expected inspection scope (data integrity, CSV, GMP, GLP, GCP)
• Required: Compliance architecture and system inventory
• Optional: Previous inspection reports and observations
• Optional: Recent industry warning letters and 483 themes