One conversational AI interface connecting specialized agents for SOP drafting, audit readiness, CSV, and 21 CFR Part 11 compliance.
Saram ConsultingThoughts and strategies on the intersection of Biotech, Artificial Intelligence, and Regulatory Compliance.
Neither RAG nor fine-tuning alone satisfies GxP compliance. The QA-RAG dual-track architecture achieves 0.717 context precision on FDA regulatory Q&A — here's how to build it.
Read Article →A multi-agent defense-in-depth architecture is the only way to achieve regulatory-grade hallucination mitigation in pharma. Here's what the research, the FDA's first AI warning letter, and the emerging tooling say about the agents you actually need.
Read Article →Standard RAG pipelines fail on quality documents. Fixed-size chunking destroys procedure context, vector search misses document IDs, and obsolete SOPs leak into answers. Here's the architecture that actually works for regulated industries.
Read Article →The consensus on continual learning for AI in GxP environments is clear — but several widely-cited regulatory claims don't hold up. Here's the verified framework for deploying adaptive AI in biopharma.
Read Article →Every credible analysis of MCP in regulated environments converges on the same architecture — a centralized gateway proxy. But several widely-cited claims about this pattern are wrong. Here's what the evidence actually supports, what the regulators actually require, and what the vendor landscape actually offers.
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