ChatGPT Can’t Write FDA-Compliant Reports. Here’s What Can.

Medium Article: https://medium.com/@jsmith0475/chatgpt-cant-write-fda-compliant-reports-here-s-what-can-e2154b82c537 "Auditable AI for FDA-Compliant Reports: Cognitive Anchoring,"by Dr. Jerry A. Smith, argues that traditional AI models like ChatGPT cannot meet the Food and Drug Administration's (FDA) requirements for reproducible and predictable documentation in pharmaceutical quality assurance (QA). Dr. Jerry A. Smith identifies the current system of manual report generation as a significant bottleneck in the industry, costing vast amounts of time and money due to bureaucratic overhead. The author proposes a solution called cognitive anchoring, which uses a multi-agent AI system constrained by four mathematical rules (symbolic, temporal, spatial, and symmetry anchoring) to ensure compliance and consistency. This system is auditable because it measures whether outputs rely on Euclidean reasoning (factual retrieval) or hyperbolic reasoning (logical inference), providing a geometric breakdown that satisfies regulatory demands. Ultimately, the piece posits that deploying this production-ready technology is a strategic necessity for Contract Research Organizations (CROs) to achieve massive cost savings, increase report throughput by thousands of times, and lead the future of pharmaceutical QA.

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