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.
Training alone won't save your Quality team from hallucinated IQ protocols and fabricated Part 11 citations. Here are the prompt design patterns, architectural guardrails, and governance frameworks that enforce correct AI usage by design — not by hope.
Read Article →The complete blueprint for fine-tuning, validating, and deploying a local LLM that generates draft OQ scripts, risk assessments, and system categorizations under GAMP 5 and FDA CSA — fully air-gapped, zero cloud dependency.
Read Article →FDA's finalized CSA guidance and GAMP 5 2nd Edition make one thing clear: AI can draft, analyze, and flag — but a qualified human must interpret, challenge, and approve. Here is the complete HITL framework for building it right.
Read Article →Computer System Validation is 60-70% documentation, traceability, and structured analysis. Here is exactly what AI agents can automate right now — organized by validation lifecycle phase, with consensus strength and realistic time savings.
Read Article →Most AI agent evaluations for pharma QA measure the wrong things. Here is the evaluation framework that actually predicts whether an agent will survive an FDA inspection — built from the convergence of every serious analysis on this problem.
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