computer-software-assurance

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justin-arndt / ai-di

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

Updated Sep 21, 2026
Python

s3bastiankoch / gxpeval

Star

A GxP-purpose-built LLM evaluation framework: anytime-valid validation, judge qualification, ALCOA+ audit, human plus AI workflow validation, drift monitoring, listener hooks, and a high-level facade on Inspect AI. Enables responsible AI use under risk-based assurance.

data-integrity gxp responsible-ai confidence-sequences llm-evaluation inspect-ai anytime-valid computer-software-assurance

Updated Jun 28, 2026
Python

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