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.
Open-source engine for ELISA/ligand-binding assay analysis, validation and QC.
50 URS + 50 paired FS for GxP-regulated computer systems. CC-BY-SA 4.0. Synthetic, AI-authored, not a regulated record.
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.
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.
CI/CD pipeline for containerized ML workloads. ECR, Cosign image signing, GxP-compliant audit trail, and Argo Events deployment trigger.
Production-ready MCP integration snippets for connecting CovaSyn to Claude Desktop, Cursor, VS Code, Python, TypeScript, and curl.
FDA 483 regulatory observation tagging specification for drug, biologic, and medical device inspections.
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.
GxP equipment-recovery decision-support copilot for regulated biotech facilities - FastAPI + Next.js/Fiori, source-grounded RAG, append-only audit log. Synthetic data, not a validated GMP system.
End-to-end ML monitoring and drift detection pipeline designed for audit-ready, regulated production environments.
Acceptance gate for Dify DSL deliverables: policy-as-code review, drift detection, and ALCOA+-aligned audit records. Deterministic, fail-closed, single runtime dependency.
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