Open-source machine-readable standard for pharmaceutical SOPs - deterministic, auditable, GxP-aligned

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.

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

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

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

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

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.

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.

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

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

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.

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