gxp

rpact: Confirmatory Adaptive Clinical Trial Design and Analysis

Open-source AI-powered quality management for regulated industries. React 19 + Hono + PostgreSQL + Prisma. eTMF, eConsent, batch records, design control, CAPA, deviations. 45+ models, 100+ endpoints, 18 countries, 12 languages. AGPL-3.0.

Consistently derive package heuristics, a next generation {riskmetric}

free open source laboratory management for reagents and samples

useR! 2024 Tutorial Slides: Good Software Engineering Practice for R Packages

Self-hosted MQTT broker with policy-controlled access and attributable decision records for industrial and regulated systems.

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

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

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.

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

A 108-document GMP CSV validation demo pack with Markdown sources and Word DOCX deliverables for a fictional LIMS/LES lifecycle.

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.

AlcoaBase (ALC) is a 100% local, open-source Document & Knowledge Management System. It unites ALCOA+ data integrity with AI, featuring deterministic PDF protocol generation and automated report data processing, training-gated workflows, RAG, and automated Computer System Validation.

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

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.

Open-source engine for ELISA/ligand-binding assay analysis, validation and QC.

LabVantage Solutions — independent third-party profile of a public API surface, by API Evangelist. LabVantage Solutions provides LIMS (Laboratory Information Management System), ELN (Electronic Lab Notebook), LES (Laboratory Execution System), and SDMS (Scientific Data Management System) platforms with APIs for GxP-compliant data exchange in pharma

Autonomous, EU AI Act-aware org-intelligence agent for regulated pharma operations (portfolio project)

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.