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.

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.

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

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.

Deterministic 21 CFR Part 11-compliant micro-agent for validating date formats and chronological sequence in electronic Batch Records. Zero LLMs. IQ/OQ/PQ validation package included.

[SUPERSEDED — see virtualryder/pharmacovigilance_agent] Original bespoke pharmacovigilance agent.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

A minimal 21 CFR Part 11-compliant electronic case report form (MERN) with a full GAMP 5 computerized-system-validation package and automated OQ evidence.

A technical, compliance-focused engineering reference for building, validating, and scaling EDC synchronization pipelines, CDISC transformations, and audit-ready clinical data workflows.

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

Production-grade input/output firewall for agentic AI. Cryptographic audit trail on every tool call and model output. 21 CFR Part 11 and SOC 2 aligned.

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

Compliance-first engineering reference and Python automation patterns for pharmaceutical cold chain temperature monitoring — FDA 21 CFR Part 11, EU GDP, ALCOA+ data integrity.

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Open-source R packages for reproducible, regulation-ready pharmaceutical data science

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.

AI-assisted pharmacovigilance platform. Drafts ICH E2B-aligned adverse-event narratives with reproducible AI, a tamper-evident audit trail, and mandatory human review.

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.