SOP 초안 작성, 감사 대응, CSV 및 21 CFR Part 11 규제 준수를 위한 특화 에이전트 연동 대화형 AI 인터페이스.
Saram Consulting바이오텍, 인공지능, 규제 컴플라이언스의 융합에 관한 심층 전략 및 실전 아키텍처 분석.
Nadella just named the structural problem every enterprise AI deployment faces: you pay for intelligence twice — once with money, and again with the institutional knowledge you leak through every correction, trace, and eval. Here's the architecture to fix it.
글 읽기 →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.
글 읽기 →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.
글 읽기 →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.
글 읽기 →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.
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