QAtrial started as three tables — requirements, tests, and an evaluation dashboard. It now has 35 database models, 90 API endpoints, 70 frontend components, and a PWA that works offline. Here’s what changed and why.
The Problem We Solved
Enterprise quality teams kept asking the same question: “Can we actually use this for real work?” The honest answer was no. QAtrial had impressive features — AI gap analysis, ISO 13485 assessment, design control, 10 industry verticals — but it ran on localStorage. No multi-user. No approvals that enforced anything. No way to track who changed what in a team setting.
The features looked good in a demo. They didn’t survive contact with a real quality department.
So we rebuilt the foundation and added the features that regulated companies actually need to operate.
Building Products for the Enterprise: Product Management in Enterprise Software
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What’s New
Just Built
A Real Backend
QAtrial now runs on PostgreSQL with a Hono API server. 35 database models. JWT authentication with 5 roles (admin, qa_manager, qa_engineer, auditor, reviewer). Every mutation logged in an append-only audit trail. Docker deployment with docker-compose up. SSO via OIDC for Okta, Azure AD, Auth0, and Keycloak.
This isn’t a demo anymore. It’s a system teams can share.
Multi-Level Approval Workflows
The old approval system was binary: pending or approved. The new workflow engine supports multi-step sequences — review, then two approvals, then a signature. Each step can require a specific role, multiple approvers, and an SLA timer. If the SLA expires, it escalates automatically. Approvers can delegate. Workflows can be paused and resumed.
This is what pharma companies need for SOP approval. What device companies need for design gate reviews. What every regulated company needs for change control.
Change Control & Deviation Management
Two new modules that are table-stakes for any GxP quality system:
Change Control tracks the full lifecycle: initiation, impact assessment, approval (using the workflow engine), implementation with assigned tasks, and effectiveness verification at 30/60/90 days. Auto-generated CC-NNN numbers. Trending by type and month.
Deviation Management handles detection through closure: classify (minor/major/critical), investigate using fishbone or 5-why templates, identify root cause, auto-create a linked CAPA, and close with evidence. Trending shows which areas generate the most deviations and which root causes recur.
These two modules alone are why companies pay MasterControl $50K/year.
Collaboration That Actually Works
Quality isn’t a solo activity. Now QAtrial has:
- Notification inbox with 11 event types — approval requests, overdue tasks, CAPA deadlines, @mentions. Server polling every 30 seconds.
- Threaded comments on any entity. @mention a colleague, they get a notification. Audit-logged.
- Task assignment with due dates, priorities, and a “My Tasks” dashboard. Tasks can be linked to CAPAs, deviations, change controls, or any other entity.
This turns QAtrial from a documentation tool into a coordination platform.
Vertical Depth
We went deep in three verticals instead of staying shallow in ten:
Medical Devices: Complaint management with trending (frequency by product/severity/month, mean time to resolution). Supplier quality scorecards with auto-requalification when scores drop below threshold. Post-market surveillance dashboard with PSUR data assembly. UDI tracking with GUDID and EUDAMED export.
Pharma: Electronic batch records with step-by-step execution, deviation flagging, and e-signature release. Stability study manager with ICH Q1A design, OOS/OOT auto-detection, and trending. Environmental monitoring with alert/action thresholds and excursion tracking. Training management with compliance dashboard and auto-retraining when SOPs update.
Software/GAMP: Live impact analysis showing the full dependency chain when a requirement changes. Computerized system inventory with GAMP 5 categories and validation status. Periodic review automation with a 7-step wizard.
Cross-vertical: Document lifecycle management (6-stage SOP versioning). Audit management with findings tracker, classification, and CAPA linkage.
PWA and Mobile Access
QAtrial is now a Progressive Web App. Install it on your phone’s home screen. The service worker caches static assets and queues mutations when you’re offline — readings, batch steps, complaints — then syncs automatically when you reconnect.
Three mobile-optimized views for field use: batch record step entry (large touch targets), environmental monitoring readings (quick numeric input), and complaint intake (simplified form).
This matters because quality work happens on manufacturing floors, in cleanrooms, and at clinical sites — not just at desks.
offline PWA for quality teams
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By the Numbers
| Metric | Before | After |
|---|---|---|
| Database models | 15 | 35+ |
| API endpoints | 60 | 90+ |
| Route files | 21 | 34+ |
| Frontend components | 42 | 70+ |
| TypeScript files | 183 | 230+ |
| Approval levels | 1 | Unlimited (configurable) |
| Mobile support | None | PWA with offline |
| Change Control | None | Full lifecycle |
| Deviation Management | None | With investigation templates |
| Notifications | Client-only | Server-backed, 11 types |
| Comments | None | Threaded, @mention |
| Tasks | None | Assigned, tracked, dashboarded |
ISO WARRIOR: Journal, Notes, Ideas, Actions, Priorities, Checklists, Log | Tool for Daily Goal Setting Tracker | Time Management | Performance Reviews | Project Office Book Gifts for Meetings
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As an affiliate, we earn on qualifying purchases.
What This Means
QAtrial is no longer competing with spreadsheets. It’s competing with Greenlight Guru, MasterControl, and Veeva Vault — at $0 license cost, with source code you can inspect, on infrastructure you control.
The workflow engine handles what MasterControl charges $50K/year for. The complaint trending does what Greenlight Guru’s device companies depend on. The batch records digitize what pharma teams still do on paper.
And it’s open source. AGPL-3.0. Every line of code is on GitHub.
QAtrial is available at github.com/MeyerThorsten/QAtrial.
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