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PharmaceuticalsPharma Quality Intelligence

Multi-agent RCA + CAPA automation designed for 21 CFR Part 11

Customer: Pharma industry partner (under NDA)

A pharmaceutical partner needed to compress root cause investigation cycle time without sacrificing regulatory rigor. We're designing a multi-agent system that runs the Agentic 6M framework, generates CAPA reports, and routes through human-approval checkpoints aligned with FDA 21 CFR Part 11.

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