1. Human Review RequirementAI-generated summaries, causal suggestions, and draft action plans are assistive in nature and must be independently reviewed, verified, and approved by qualified quality professionals before operational implementation or regulatory submission.
2. Dependence on Input QualityThe reliability of AI-assisted outputs depends directly on the accuracy, completeness, and objectivity of input data. Biased, incomplete, or inaccurate records will produce flawed recommendations.
3. Regulatory Advisory NoticeQuality Intelligence provides general quality management support and does not guarantee QMS, regulatory, or FDA/cGMP compliance, audit success, or certification. It does not replace formal third-party conformity assessments, official registrar audits, legal counsel, or certified quality professional judgment.