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Saram ConsultingThoughts and strategies on the intersection of Biotech, Artificial Intelligence, and Regulatory Compliance.
Five independent analyses converge on the same answer for life sciences quality documents — but the devil is in the phasing. A research-grade comparison of seven RAG architectures with benchmarks, cost data, and a decision framework for regulated industries.
Read Article →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.
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