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Saram ConsultingThoughts and strategies on the intersection of Biotech, Artificial Intelligence, and Regulatory Compliance.
Ten independent analyses were asked the same question: if you're building a QMS from scratch, would you implement OKF? All ten converged on the same architecture. Here's the blueprint — with PostgreSQL 19 graph queries, MCP tool-use, and OKF as the agent-facing contract.
Read Article →The arguments for applying Google's Open Knowledge Format to quality documents are compelling — until you stress-test them against 21 CFR Part 11, GAMP 5 validation costs, and what Veeva is actually building. A hard look at why the API layer wins over the format layer.
Read Article →Nine independent analyses of applying Google's Open Knowledge Format to quality documents all landed on the same architecture — but not the one either side expected. The pattern is right. The format is wrong. And the vendors are already building the real solution.
Read Article →Google's Open Knowledge Format (OKF) was built for data teams, but life sciences quality is a stronger fit. Here's the complete picture — the spec, the GxP adaptations, the regulatory friction points, the architecture every analysis converged on, and the rollout playbook for existing systems.
Read Article →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.
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