gamp5

Open-source, GitHub-native eQMS baseline for medical device and regulated software teams. Issues, PRs, Actions, and Releases form the quality system of record. Covers ISO 9001, ISO 13485, ISO 14971, IEC 62304, IEC 62366-1, ISO/IEC 27001, ISO/IEC 42001, GDPR/nFADP, plus an optional GAMP 5 / 21 CFR Part 11 overlay.

50 URS + 50 paired FS for GxP-regulated computer systems. CC-BY-SA 4.0. Synthetic, AI-authored, not a regulated record.

nydok is a combined specification writing and testing framework, for producing consistent and traceable specification documents.

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.

Agentic workflows that generate audit-ready validation evidence for AI systems in GxP environments — aligned with EU Annex 22 and GAMP 5. Compliance decisions stay with your QA.

KRISS 표준시 기준으로 폐쇄망 GMP 장비들의 NTP 시각 동기 상태를 실시간 감시·검증하는 시스템 (읽기 전용, 시각 미배포). FastAPI + React, GAMP5 V모델.

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.

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.

Pharmacovigilance GraphRAG assistant: cited, grounded Q&A over FDA drug labels using Neo4j + FAERS adverse-event data. Free-tier stack with risk-based OQ/PQ validation.

Excel-Based LIMS Development and Computer System Validation (CSV) project Following GAMP 5,

Validated DESeq2 RNA-Seq pipeline with full CSV lifecycle (URS, IQ/OQ/PQ), 21 CFR Part 11 and ALCOA+ compliance mappings, and GAMP 5 documentation.