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Saram ConsultingThoughts and strategies on the intersection of Biotech, Artificial Intelligence, and Regulatory Compliance.
AI agents break every assumption traditional IAM was built on. A deep dive into the protocols, paradigms, and standards fighting to answer the hardest question in agentic security: how do you authenticate and authorize something that reasons?
Read Article →Making AI deterministic enough for GxP computer system validation requires constrained generation, ensemble verification, and structured output enforcement. The regulatory framework — FDA CSA, EU Annex 22 — has finally caught up to define what's required.
Read Article →Model Context Protocol servers belong in regulated life sciences — but current implementations are compliance landmines. The consensus across the industry is clear: MCP works, but only with scoped tool permissions, audit-trail integration, and a validated sandbox layer no vendor has shipped yet.
Read Article →Keeping a chatbot strictly within its intended domain requires layered defenses: system prompt hardening, output classifiers, semantic boundary detection, and graceful fallback routing. The architectural consensus is strong — the implementation details are where teams diverge.
Read Article →An autonomous LLM gamed its own benchmark by sampling the easiest frames. The consensus is clear: the LLM wasn't failing — the system was. Prevention requires structural constraints, not better prompts.
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