FOR IMMEDIATE RELEASE
April 2026
QAtrial v3.0.0 delivers Docker deployment, SSO, validation documentation, webhooks, and Jira/GitHub integrations under an AGPL-3.0 license — making enterprise-grade quality management accessible to every regulated company.
QAtrial, the open-source quality management platform for regulated industries, today announced the general availability of version 3.0.0. The release completes a five-phase development arc that transforms QAtrial from a requirements management prototype into a fully operational quality workspace with a production backend, Docker deployment, single sign-on, built-in validation documentation, and integrations with the tools engineering and quality teams already use.
Version 3.0.0 runs on a Hono + PostgreSQL + Prisma stack with 60+ REST API endpoints, 15 database models, and JWT-based authentication supporting five role-based access levels. A single docker-compose up command starts the entire stack — application server, PostgreSQL 16 database, and static file serving — with health checks and persistent storage volumes configured out of the box.
Key Capabilities
Single Sign-On (OIDC). QAtrial integrates with Okta, Azure AD/Entra ID, Auth0, Keycloak, and Google Workspace. First-time SSO users are auto-provisioned with a configurable default role, eliminating manual account creation for organizations with existing identity providers.
Validation Package. The release ships with five validation documents: Installation Qualification (9 test steps), Operational Qualification (18 test steps), a Performance Qualification template, a Compliance Statement mapping QAtrial against 21 CFR Part 11 (15 sections), EU Annex 11 (17 sections), and GAMP 5 Category 4, and a Traceability Matrix linking 75 regulatory requirements to specific product features and test IDs.
Compliance Starter Packs. Four pre-configured packs — FDA Software Validation (GAMP 5), EU MDR Medical Device QMS, FDA GMP Pharmaceutical Quality, and ISO 27001 + GDPR — auto-fill the setup wizard with the correct country, vertical, modules, and project type.
Webhooks and Integrations. Fourteen webhook events cover requirement changes, test failures, CAPA lifecycle transitions, approval requests, electronic signatures, and evidence uploads. Payloads are signed with HMAC-SHA256. Bidirectional Jira Cloud sync and GitHub PR linking with CI test result import are available from the settings page.
Audit Mode. Administrators generate time-limited read-only links (24 hours, 72 hours, or 7 days) that give auditors a seven-tab view of the project — overview, requirements, tests, traceability, evidence, audit trail, and signatures — without requiring a login.
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Open-Source Quality Management
“Quality management software has been locked behind six-figure license fees for too long,” said the QAtrial project team. “Regulated companies — especially small and mid-size manufacturers, biotechs, and software firms — deserve tools that are transparent, auditable, and affordable. With QAtrial under AGPL-3.0, any organization can deploy a validated quality workspace on their own infrastructure at zero license cost, and any auditor can inspect the source code that manages their quality records.”
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Market Context
The global quality management software market is projected to exceed $12.5 billion by 2028. Regulatory pressure continues to intensify: the FDA’s Quality Management System Regulation (QMSR), effective February 2026, requires medical device companies to align with ISO 13485. Meanwhile, FDA data shows a 115% increase in medical device recalls over the past decade. Companies navigating these requirements need systems that are both rigorous and accessible.
QAtrial addresses this gap with a platform that covers 10 industry verticals (pharmaceuticals, biotechnology, medical devices, CRO/clinical research, clinical laboratories, logistics/GDP, software/IT, cosmetics/chemical, aerospace, and chemical/environmental), 37 countries, and 15 composable quality modules — from audit trail and electronic signatures to CAPA, risk management, and supplier qualification.
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Availability
QAtrial v3.0.0 is available immediately on GitHub at https://github.com/MeyerThorsten/QAtrial under the AGPL-3.0 license.
Getting started:
git clone https://github.com/MeyerThorsten/QAtrial.git
cd QAtrial
cp .env.example .env
docker-compose upThe application is accessible at http://localhost:3001 within minutes.
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Website and Resources
QAtrial maintains a dedicated website at https://qatrial.com/ with product documentation, deployment guides, feature overviews, and community resources. The site serves as the central hub for organizations evaluating QAtrial for their quality management needs, including detailed walkthroughs of compliance starter packs, validation documentation, and integration capabilities. Teams can explore the full feature set, review regulatory coverage across industries and jurisdictions, and access getting-started guides — all before cloning a single line of code.
Website: https://qatrial.com/
About QAtrial
QAtrial is an open-source, AI-assisted quality management platform built for regulated industries. It combines requirements management, test management, risk assessment, CAPA tracking, electronic signatures, and audit trail functionality in a single workspace. The platform supports 12 languages, 10 industry verticals, 37 countries, and 4 compliance starter packs. The AI co-pilot assists with test case generation, risk classification, gap analysis, CAPA suggestions, and requirement quality checks across multiple LLM providers including Anthropic, OpenAI, and local Ollama deployments. QAtrial comprises 130+ source files and 25,000+ lines of TypeScript code.
Website: https://qatrial.com/
GitHub: https://github.com/MeyerThorsten/QAtrial
License: AGPL-3.0
Media Contact: Available via GitHub Issues at https://github.com/MeyerThorsten/QAtrial
