21-cfr-part-11

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.

FDA CSA-compliant test automation framework. Built with Python and Playwright to automate pharmaceutical risk assessments, ALCOA+ evidence capture, and 21 CFR Part 11 validation workflows.

Portfolio-safe quality deviation risk monitoring prototype using synthetic data, Python, SQL, and FastAPI.

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.

Portfolio-safe Computer System Validation (CSV) evidence tracker — requirements traceability, IQ/OQ/PQ test execution, deviation log, and 21 CFR Part 11-aligned audit trail. Built with Python, FastAPI, React, and SQLite using synthetic data.

FDA 21 CFR Part 11 compliant MLOps. Automated IQ/OQ/PQ validation, MLflow integration, model registry with audit trails.

Automated lab temperature monitoring deployed on a Raspberry Pi with FDA 21 CFR Part 11 compliant audit trails. Replaces ~250 hours/year of manual logging.

R package: Tamper-evident, hash-chained audit logging for R applications

Open-source, compliance-by-construction LIMS for clinical-trial biobanking — tamper-evident audit, e-signatures, and specimen chain of custody enforced in PostgreSQL.

Canonical handoff contracts and a hash-verified verifier suite for the research scaffold evaluation apparatus. Regulated-industry data-integrity grammar (ALCOA+, 21 CFR Part 11) applied to AI workflow tooling.

Agentic AI-Driven Autonomous Pharmaceutical Supply Chain & Inventory Management System (SCM/IMS) simulating cGMP & 21 CFR Part 11 regulatory workflows. Powered by Java 24, JADE multi-agent framework, LangChain4j, PostgreSQL, Javalin REST API, and Web UI.

Django REST + React platform that turns pharma SOPs into role-specific quizzes via NVIDIA NIM (Llama 3.1), with a deterministic offline fallback, RBAC-gated endpoints, 21 CFR Part 11-style e-signatures/audit trail, and Leitner+FSRS adaptive retraining.

[SUPERSEDED — see virtualryder/pharmacovigilance_agent] Original bespoke pharmacovigilance agent. The maintained, template-based version lives at github.com/virtualryder/pharmacovigilance_agent.

Audit-trailed RAG system for drug-safety triage. Refusal-first answer contract with per-answer citation verification, a hash-chained tamper-evident audit log, and human sign-off with 21 CFR Part 11 e-signatures. Python · FastAPI · PostgreSQL/pgvector · Ollama. GAMP 5-aligned demonstrator on public FDA data.

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.

21 CFR Part 11 compliance collaboration platform for cross-hub laboratory task management. React + TypeScript with electronic signatures, SLA tracking, document warehousing, and audit trails.

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Production reference architecture: High-throughput edge ingestion daemons for life science instruments (Go, 21 CFR Part 11, S3)

pen-source GxP-compliant predictive maintenance platform for U.S. pharmaceutical supply chain resilience. Aligned with Executive Order 14017. DOI: 10.5281/zenodo.19310968