prepare-inspection-readiness

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

Expected: A risk-rated analysis of inspection focus areas specific to the inspecting authority. On failure: If recent 483/warning letter data is unavailable, consult the FDA warning letter database, EMA inspection reports, or industry publications for the most current trends.

Expected: A quantified readiness assessment with prioritised remediation actions. On failure: If overall readiness is below 70%, consider requesting an inspection delay (if permitted) and implementing emergency remediation.

透過評估針對機構特定重點領域（FDA、EMA、MHRA）的準備情況，為組織進行監管檢查做好準備。涵蓋警告信和 483 主題分析、模擬檢查協議、文件包準備、檢查物流和回應範本建立。當已宣布或預計進行監管檢查時、定期自我評估到期時、自上次檢查以來已實施新系統時，或在可能引起監管機構注意的重大審計結果之後使用。 來源：pjt222/development-guides。