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

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

Audit-first MQTT control plane for regulated industrial systems.

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

Auto-generate structured GxP/regulatory audit reports from assessment data — GMP, ISO 13485, EU GMP, Supplier Audits — with compliance scoring, CAPA tracking, and AI-written narratives

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

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

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

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.

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.

Executive portfolio showcasing Healthcare Informatics, Pharmaceutical Quality, AI, Supply Chain Transformation, Data Analytics, and Project Management.

Segmented Azure infrastructure simulating a GxP pharmaceutical company: tiered + departmental (QA/QC/MFG/PKG) network segmentation, hardened storage with data-integrity controls, Key Vault, and compliance governance. IaC in Bicep + Azure CLI, validated in CI.

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.

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.