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Saram ConsultingThoughts and strategies on the intersection of Biotech, Artificial Intelligence, and Regulatory Compliance.
A comprehensive engineering and governance playbook for deploying agentic AI in GxP environments — risk tiering, GAMP 5 validation, ALCOA+ audit trails, and the anti-patterns that get 483s.
Read Article →The hallucination war has shifted from 'build better models' to 'build better systems.' Here's what OpenAI, Anthropic, DeepMind, Meta, and xAI are actually doing — and why none of it will reach zero.
Read Article →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.
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