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.
The Quality Management System Regulation replaced the 30-year-old QSR on February 2, 2026. Here is what actually changed, why it matters for AI agents in quality operations, and where the real constraints remain.
글 읽기 →Graph databases store relationships as first-class citizens — physical pointers on disk, not computed joins. With ISO GQL now standardized and GraphRAG driving AI adoption, the $2B market is no longer niche. A deep dive on architecture, query languages, and when graphs actually beat relational.
글 읽기 →Vector RAG retrieves semantically similar chunks. GraphRAG builds a knowledge graph from your corpus, clusters it hierarchically, and pre-computes community summaries — enabling global sensemaking queries that flat retrieval fundamentally cannot answer. A deep dive on architecture, cost, and the variant landscape.
글 읽기 →When your agent searches the web to fix an error, it is asking the open internet for instructions. Attackers are already poisoning the answers. Here is the architecture that stops them.
글 읽기 →A production-ready architecture combining PostgreSQL, Qdrant, and Memgraph with Pydantic AI agents for GxP-compliant quality management and computer system validation.
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