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

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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.

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.

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.

FDA 483 regulatory observation tagging specification for drug, biologic, and medical device inspections.

rpact: Confirmatory Adaptive Clinical Trial Design and Analysis

Audit-first MQTT control plane for regulated industrial systems.

CI/CD pipeline for containerized ML workloads. ECR, Cosign image signing, GxP-compliant audit trail, and Argo Events deployment trigger.

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

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}

Data analysis and quality control dashboard for a Pharmaceutical Manufacturing Execution System (MES). Focused on GxP compliance, outlier detection, and process stability.

End-to-end ML monitoring and drift detection pipeline designed for audit-ready, regulated production environments.

Compliance-aware RAG system for regulated SOP search (GxP-ready design)

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

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

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

free open source laboratory management for reagents and samples