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.
Building local RAG on Claude Enterprise converges on a single architecture: hybrid retrieval with contextual compression, chunk-level reranking, and strict metadata filtering. Anthropic's own benchmarks confirm it works.
Read Article →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.
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