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.
Agent performance is no longer about the model. The same LLM produces 6x different results depending on its harness. Here's the anatomy, the ecosystem, and why this shift matters for anyone building agents in regulated environments.
Read Article →Uploading GxP SOPs into Claude Enterprise Project Knowledge creates uncontrolled document copies outside your validated QMS. Here's exactly what auditors will flag, why, and the architecture they want to see instead.
Read Article →Generic chunking destroys life science documents. Here's the document-type-specific chunking architecture for SOPs, Deviations, CAPAs, Work Instructions, and Batch Records — with the metadata schema, evaluation framework, and compliance controls that make it defensible.
Read Article →MTP speculative decoding delivers 1.4–2.2x faster generation with zero accuracy loss. Here is how it works, which hardware benefits most, and the exact flags to set for Qwen3.6 on llama.cpp, vLLM, and Unsloth Studio.
Read Article →LLMs don't debug — they simulate what a fix looks like. Here is the architecture behind the pretense, the empirical evidence quantifying it, and the seven escape hatches that actually work.
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