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Saram ConsultingThoughts and strategies on the intersection of Biotech, Artificial Intelligence, and Regulatory Compliance.
Ten analyses converged on the same answer: don't replace your QMS — build a read-only sidecar around it. Here are the ten patterns, ranked by risk, with a concrete rollout timeline from week 1 to month 9.
Read Article →Google's Open Knowledge Format (OKF) was built for data teams. But life sciences quality documents — SOPs, deviations, CAPAs, validations — are a far better fit. Here's why, and how to adapt it for GxP environments without breaking compliance.
Read Article →Quality documents are 70-90% boilerplate by design — templates, regulatory references, controlled vocabulary. That structural repetition makes them the ideal workload for prompt caching. Here's the architecture that takes cache hit rates from single digits to 80%+ in a GxP-compliant system.
Read Article →A technical deep-dive into the three layers of LLM caching — prompt prefix, semantic, and KV-cache — with production benchmarks, provider pricing, and an implementation playbook that takes cache hit rates from single digits to 80%+.
Read Article →Building your own AI gateway is one of the most practical infrastructure investments in the AI stack. Here's the verified architecture, the tools that actually exist, and how to make it work in regulated environments.
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