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eu-annex-11

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paraqualis / paraqualis-gxp

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Life-sciences CSV & GxP toolkit for Claude Code — GAMP 5, 21 CFR Part 11, EU GMP Annex 11, the live eCFR & openFDA, and an IQ/OQ/PQ qualification engine. Slash commands, auto-invoked skills, parallel sub-agents, an MCP server, and a document-protection hook.

csv validation mcp qualification gamp pharma life-sciences regulatory openfda gxp gamp5 mcp-server claude-code ecfr computer-system-validation 21-cfr-part-11 claude-code-plugin claude-plugin iq-oq-pq eu-annex-11
  • Updated Oct 11, 2026
  • Python

VedantPanchal23 / zydus-predictive-maintenance

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AI-Powered Predictive Maintenance & Oncology Asset Intelligence Platform for Zydus Lifesciences. Features real-time Kafka & OPC-UA telemetry streaming, physics-informed ML ensemble (XGBoost, LSTM, SHAP), and US FDA 21 CFR Part 11 cryptographic audit trails.

react python docker kubernetes redis machine-learning airflow cryptography pytorch xgboost apache-kafka scada anomaly-detection opcua timescaledb mlops fastapi gamp5 21-cfr-part-11 eu-annex-11
  • Updated Sep 1, 2026
  • Python

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