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.
FDA issued its first AI-focused cGMP warning letter. MHRA caught AI-generated inspection responses citing nonexistent regulations. EMA is writing Annex 22 specifically for AI in GMP. The audit profession is fundamentally rewiring how it evaluates AI — and most biopharma companies aren't ready.
Read Article →Hardened PLCs, chromatographs, and cleanroom controllers can't take backup agents, inbound traffic, or OS patches — yet auditors expect documented, tested recovery of the exact validated state. The architectures that work, the controls that make a restore defensible, and why 'we have backups' is not an answer.
Read Article →Tabletop exercises will not save you from a 483. What auditors actually check in a DR plan, why technical restore testing is non-negotiable for Tier 1 GxP systems, and how to architect an AI agent that continuously proves your regulated systems are recoverable.
Read Article →Every knowledge graph in a regulated company is one hallucinated edge away from being an audit finding. The fix is not a better prompt — it is an extraction architecture where the LLM proposes and deterministic infrastructure disposes: ontology-first design, span-grounded two-pass extraction, NLI verification, entity resolution, and a claim ledger.
Read Article →Your agent isn't stuck — it was told to think. LLM-generated prompts inflate perceived task complexity, reasoning models price thinking off surface signals, and the result is thousands of hidden reasoning tokens and zero tool calls. Here is the mechanism, the model behavior behind it, and the prompting discipline that fixes it.
Read Article →