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.

通过评估针对机构特定重点领域（FDA、EMA、MHRA）的准备情况，为组织进行监管检查做好准备。涵盖警告信和 483 主题分析、模拟检查协议、文档包准备、检查物流和响应模板创建。当已宣布或预计进行监管检查时、定期自我评估到期时、自上次检查以来已实施新系统时，或在可能引起监管机构注意的重大审计结果之后使用。 来源：pjt222/development-guides。