62  Findings, Responses & Remediation

62.1 Types of Findings

  • Minor observations
  • Major observations
  • Critical findings

62.2 CRA Responsibilities

  • Review inspection findings
  • Support root cause analysis
  • Assist in CAPA development
  • Track remediation progress

62.3 Response Principles

  • Objective and factual
  • Supported by evidence
  • Action-oriented
  • Timely