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.
A week's worth of deep technical work — 20 posts covering RAG architecture for regulated documents, the MCP gateway pattern, multi-agent hallucination defense, LLM caching economics, and a rigorous stress-test of Google's Open Knowledge Format for life sciences quality systems.
Read Article →MasterControl's new Catalog product promises a 'single source of truth' for life sciences master data. The problem is where that truth lives. When you build your data architecture inside a vendor's platform, you don't own your most critical enterprise asset — you rent it. Here's why that matters more than ever in the AI era.
Read Article →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 →