Autonomous GxP Data Integrity & Local LLM Validation Engine. Detects HPLC peak manipulation under USP <621>, enforces 21 CFR Part 11 cryptographic audit trails, and qualifies local IBM Granite 8B via FDA CSA principles.
csv fda pytorch quality-assurance csa chromatography hplc data-integrity gxp pharmaceutical-manufacturing ai-validation local-llm gamp5 pydantic-v2 ibm-granite 21-cfr-part-11 cryptographic-audit-trail computer-software-assurance usp-621
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Updated
Sep 21, 2026 - Python