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
nydok is a combined specification writing and testing framework, for producing consistent and traceable specification documents.
Audit-first MQTT control plane for regulated industrial systems.
50 URS + 50 paired FS for GxP-regulated computer systems. CC-BY-SA 4.0. Synthetic, AI-authored, not a regulated record.
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.
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.
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 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 pharmaceutical, biotech, and clinical laboratory environments.
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.
A 108-document GMP CSV validation demo pack with Markdown sources and Word DOCX deliverables for a fictional LIMS/LES lifecycle.
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.
Aizon is a B2B SaaS manufacturing-intelligence platform for GxP pharmaceutical manufacturers and CDMOs. It turns process data into AI-driven recommendations to increase yield, reduce deviations, and prevent batch loss without replacing existing MES, LIMS, ERP, or historian systems.
Apprentice (apprentice.io) is an AI-native manufacturing platform for the life sciences, delivering Tempo Manufacturing Cloud — a GxP-compliant SaaS suite that unifies a Manufacturing Execution System (MES), Laboratory Execution System (LES), Augmented Work Instructions (AWI), and the Tandem collaboration/guest layer across pharmaceutical…
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