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Saram ConsultingThoughts and strategies on the intersection of Biotech, Artificial Intelligence, and Regulatory Compliance.
AI agents designed for pharmaceutical computer system validation converge on the same architecture — and consistently miss the single most important regulatory precedent. Here's what the consensus gets right, where it diverges, and the three blind spots that should shape every CSV AI strategy.
Read Article →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.
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