QAtrial

KO | EN

gitlite — search

#hacktoberfest #typescript #llm #android #machine-learning #linux #macos #nodejs #java #kubernetes #pytorch #security #openai #ios

(★ 15)

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.

QAtrial 최신버젼 다운로드

최종 버전 다운로드 (.zip)

// repository documentation

Was this content helpful?

★ 0 (0 ratings)

# QAtrial — Regulated Quality Workspace

**Open-source, AI-powered quality management platform for regulated industries.**

QAtrial is a full-stack quality management system built for pharma, medical devices, biotech, CROs, and software/GAMP teams. It combines requirements and test management with AI-assisted compliance, electronic signatures, audit trails, and industry-specific workflows — all under the AGPL-3.0 license.

**Live Demo:** [qatrial.vercel.app](https://qatrial.vercel.app) | **Website:** [qatrial.com](https://qatrial.com)

---

## Technology

| Layer | Technology | Details |
|-------|-----------|---------|
| **Frontend** | React 19 + TypeScript | Vite 8, Tailwind CSS 4, Zustand (20+ stores), TanStack Table v8, Recharts 3, Lucide icons |
| **Backend** | Hono (Node.js) | TypeScript-first HTTP framework, 100+ REST endpoints, 40+ route files, SSE realtime |
| **Database** | PostgreSQL 16 + Prisma v7 | 45+ models, append-only audit trail, relational integrity, full-text search |
| **Auth** | JWT + bcrypt + OIDC | Access/refresh tokens, 5-role RBAC, SSO (Okta, Azure AD, Auth0, Keycloak, Google Workspace) |
| **AI** | Multi-provider (9 prompts) | Anthropic, OpenAI, OpenRouter, Ollama (local). Server-side proxy. Predictive analytics. |
| **Deployment** | Docker + Helm | Multi-stage Dockerfile, docker-compose (PostgreSQL + app), Helm chart for Kubernetes |
| **Realtime** | Server-Sent Events | Live entity updates, presence tracking, heartbeat, online user indicators |
| **i18n** | react-i18next | 12 languages, 500+ translation keys, lazy-loaded via HTTP backend |
| **PWA** | Service Worker | Offline caching, IndexedDB mutation queue, mobile-optimized views, install prompt |
| **Clinical** | eTMF + eConsent | TMF Reference Model v3.3, consent forms with comprehension, signatures, re-consent |
| **Integrations** | 6 connectors | Jira, GitHub, SAP QM, LabWare LIMS + webhooks (14 events, HMAC signing) |

## Architecture

```
┌──────────────────────────────────────────────────────────────────┐
│                         Browser (React 19)                        │
│                                                                    │
│  ┌───────────┐ ┌───────────┐ ┌───────────┐ ┌──────────────────┐  │
│  │  80+ UI   │ │  20+      │ │  PWA      │ │  i18n            │  │
│  │Components │ │  Zustand   │ │  Service  │ │  12 languages    │  │
│  │  + Forms  │ │  Stores    │ │  Worker + │ │  500+ keys       │  │
│  │  Builder  │ │  + Hooks   │ │  Offline  │ │  + lazy loading  │  │
│  └───────────┘ └───────────┘ └───────────┘ └──────────────────┘  │
│         │              │                                           │
│   Standalone Mode      │  Server Mode (VITE_API_URL)              │
│   (localStorage)       │         │                                 │
└────────────────────────┼─────────┼─────────────────────────────────┘
                         │         │
                         ▼         ▼
              ┌───────────────────────────────┐
              │       Hono API Server          │
              │       (Port 3001)              │
              │                                │
              │  ┌──────────────────────────┐  │
              │  │  40+ Route Modules       │  │
              │  │  JWT + RBAC + OIDC SSO   │  │
              │  │  Audit Service (append)  │  │
              │  │  Webhook Dispatch (HMAC) │  │
              │  │  AI Proxy (multi-LLM)    │  │
              │  │  SSE Realtime + Presence │  │
              │  │  Predictive Analytics    │  │
              │  │  Full-Text Search        │  │
              │  └──────────────────────────┘  │
              │               │                │
              └───────────────┼────────────────┘
                              │
               ┌──────────────┼──────────────┐
               │              │              │
               ▼              ▼              ▼
    ┌──────────────┐ ┌──────────────┐ ┌──────────────┐
    │ PostgreSQL 16│ │  File Store  │ │  External    │
    │ (Prisma v7)  │ │  (uploads/)  │ │  Systems     │
    │              │ │              │ │              │
    │ 45+ Models:  │ │  Evidence    │ │  Jira Cloud  │
    │ Users, Orgs, │ │  eTMF docs   │ │  GitHub      │
    │ Projects,    │ │  Batch files │ │  SAP QM      │
    │ Requirements,│ │  Form files  │ │  LabWare     │
    │ Tests, CAPA, │ │              │ │  LIMS        │
    │ Risks, Audit,│ └──────────────┘ │  Slack/Teams │
    │ Evidence,    │                   │  (webhooks)  │
    │ Approvals,   │                   └──────────────┘
    │ Signatures,  │
    │ Complaints,  │
    │ Suppliers,   │
    │ Batches,     │
    │ Training,    │
    │ Documents,   │
    │ Workflows,   │
    │ Deviations,  │
    │ ChangeCtrl,  │
    │ Stability,   │
    │ UDI, PMS,    │
    │ Monitoring,  │
    │ Audits, KPI, │
    │ Notifications│
    │ Comments,    │
    │ Tasks, Forms,│
    │ TMF, Consent,│
    │ Submissions, │
    │ Quizzes, ... │
    └──────────────┘
```

**Dual mode:** QAtrial runs in **standalone mode** (browser-only, localStorage, no server needed) for demos and individual use, or **server mode** (PostgreSQL-backed, multi-user, API-driven) for team and enterprise use. Same codebase, same UI — just set `VITE_API_URL` to switch.

**Kubernetes:** Deploy via Helm chart (`helm/qatrial/`) with configurable replicas, ingress, TLS, persistent volumes, and secrets.

## Core Model

```
Country (jurisdiction) × Vertical (domain) × Project Type (execution) × Modules (quality controls)
```

**45+ database models · 100+ API endpoints · 80+ components · 9 AI prompts · 12 languages · 10 verticals · 18 country templates · 15 modules · 4 compliance packs · 5 validation documents · 6 integrations · Helm chart**

---

## Features

### Requirements & Test Management
- CRUD for requirements and tests with auto-generated IDs (REQ-001, TST-001)
- Multi-select linking between tests and requirements
- Status tracking (Draft/Active/Closed for reqs, Not Run/Passed/Failed for tests)
- Enriched metadata: tags, regulatory references, risk level, evidence hints
- Sortable, searchable tables with TanStack Table
- Excel/CSV import with 3-step wizard (upload, map columns, import)
- CSV export (requirements, tests, all) with UTF-8 BOM

### Industry Verticals (10 GxP domains)
| Vertical | Standards |
|----------|----------|
| Pharmaceuticals | FDA 21 CFR 210/211, ICH Q7/Q10, EU GMP Annex 11 |
| Biotechnology | 21 CFR Part 600, ICH Q5A-E |
| Medical Devices | QMSR/21 CFR 820, ISO 13485, IEC 62304, ISO 14971 |
| CRO / Clinical Research | ICH E6(R3), 21 CFR Part 58 |
| Clinical Laboratories | CLIA, CAP, ISO 15189 |
| Logistics / GDP | WHO GDP, EU GDP, FDA DSCSA |
| Software & IT (GAMP/CSV) | 21 CFR Part 11, EU Annex 11, GAMP 5 2nd Ed |
| Cosmetics / Chemical | ISO 22716, OECD GLP, REACH |
| Aerospace | AS9100D, DO-178C, DO-254, EASA Part 21 |
| Chemical / Environmental | REACH, CLP, TSCA, ISO 14001, ISO 45001 |

### Vertical-Depth Feature Tracks

**Medical Device Track:**
- **Complaint Management**: Intake form, investigation workflow (received -> investigating -> resolved -> closed), trending dashboard (by month/severity/product/MTTR), FSCA tracking, CAPA linkage, regulatory reportable flag
- **Supplier Quality Scorecards**: Performance metrics (defect rate, on-time delivery), risk-based scoring, auto-requalification (score < 50 -> conditional), audit scheduling/tracking
- **Post-Market Surveillance (PMS)**: Aggregated entries, PSUR data assembly, summary dashboard
- **UDI Management**: Device identifier tracking, GUDID/EUDAMED export

**Pharma Track:**
- **Electronic Batch Records**: Template-driven, step execution with deviations, review-by-exception, e-signature release, yield calculation
- **Stability Study Manager**: ICH Q1A design, storage conditions, pull schedules, OOS/OOT auto-detection, trending charts
- **Environmental Monitoring**: Monitoring points with thresholds, readings with auto-excursion detection, trending
- **Training Management (LMS-lite)**: Plans, courses, records, matrix, compliance dashboard, auto-retraining triggers

**Software/GAMP Track:**
- **Live Impact Analysis**: Requirement/test graph chains, what-if analysis
- **Computerized System Inventory**: GAMP 5 categories, validation status, risk levels, overdue detection
- **Periodic Review Automation**: 7-step wizard, auto-pull data, schedule next review

**Cross-Vertical:**
- **Document Lifecycle Management**: SOP versioning (draft -> review -> approved -> effective -> superseded -> retired), version history, distribution tracking
- **Closed-Loop CAPA Enhancement**: Cascade triggers (SOP update, retraining)
- **Audit Management**: Schedule, findings tracker, CAPA linkage, classification (observation/minor/major/critical)

### 15 Composable Quality Modules
Audit Trail, Electronic Signatures, Data Integrity (ALCOA+), Change Control, CAPA, Deviation Management, Training, Supplier Qualification, Complaint Handling, Risk Management, Document Control, Backup/DR, Access Control, Validation/CSV, Traceability Matrix

### Country-Specific Templates (14 countries + EU-wide)
US, Germany, UK, France, Japan, South Korea, Canada, Mexico, China, India, Italy, Netherlands, Spain + EU-wide base. 37 countries supported in the setup wizard. Each with regulatory requirements and tests referencing local standards and authorities.

### Compliance Starter Packs (4 packs)

One-click setup for common regulatory frameworks via the wizard's Step 0:

| Pack | Country | Vertical | Modules |
|------|---------|----------|---------|
| FDA Software Validation (GAMP 5) | US | Software/IT | 7 modules (Part 11, CSV, audit trail, e-sig, etc.) |
| EU MDR Medical Device QMS | EU/DE | Medical Devices | 9 modules (risk, CAPA, supplier, training, etc.) |
| FDA GMP Pharmaceutical Quality | US | Pharma | 10 modules (cGMP, data integrity, change control, etc.) |
| ISO 27001 + GDPR Compliance | EU/DE | Software/IT | 7 modules (access control, risk, backup, etc.) |

### AI Compliance Co-Pilot
- **Test Case Generator**: Auto-generate 4-6 test cases from a requirement, context-aware (country, vertical, standards, risk level)
- **Risk Classification**: AI proposes severity/likelihood using vertical-specific taxonomies (ISO 14971, ICH Q9, GAMP 5)
- **Gap Analysis**: Compare project against regulatory standards, identify covered/partial/missing clauses
- **CAPA Suggestions**: AI-powered root cause analysis and corrective action proposals for failed tests
- **Executive Brief**: One-click C-level compliance summary
- **Validation Summary Report (VSR)**: AI-generated 7-section audit-ready report with PDF export
- **QMSR Gap Analysis**: Medical device quality system regulation gap analysis
- **Requirement Extraction**: AI-assisted extraction of requirements from source documents
- **Quality Check**: Requirement quality analysis detecting vagueness, untestability, ambiguity, incompleteness, duplicate risk, and missing acceptance criteria
- Multi-provider support: Anthropic, OpenAI-compatible (OpenRouter, Ollama, etc.)
- Server-side proxy mode (`/api/ai/complete`) for production deployments (keeps API keys secure)

### Audit Mode (Read-Only Shareable Links)
- Admin generates time-limited shareable links (24h / 72h / 7d expiry)
- Auditors access `/audit/{token}` -- no login required
- 7-tab read-only view: Overview, Requirements, Tests, Traceability, Evidence, Audit Trail, Signatures
- Print and Download Report buttons
- Amber "Read-Only" banner with expiry countdown

### 7 Dashboard Views
1. **Overview**: Coverage metrics, status charts, traceability matrix, orphaned items
2. **Compliance**: Weighted readiness score + gap analysis heatmap
3. **Risk**: Interactive 5x5 severity x likelihood matrix
4. **Evidence**: Per-requirement evidence completeness tracking
5. **CAPA**: Failed test funnel with AI corrective action suggestions
6. **Trends**: Status distributions, risk distribution, coverage by category
7. **Portfolio**: Multi-project overview with readiness scores

### Server-Side Dashboards
- `GET /api/dashboard/:projectId/readiness` -- weighted compliance score
- `GET /api/dashboard/:projectId/missing-evidence` -- requirements/tests without evidence
- `GET /api/dashboard/:projectId/approval-status` -- counts by entity type and status
- `GET /api/dashboard/:projectId/capa-aging` -- open CAPAs with aging buckets (0-7d, 7-30d, 30-90d, 90d+)
- `GET /api/dashboard/:projectId/risk-summary` -- risk level counts + matrix data

### Report Generation
- Validation Summary Report (VSR) -- 7-section audit-ready report
- Executive Compliance Brief -- AI-generated one-pager
- Regulatory Submission Package -- formatted per authority (FDA 510(k), EU MDR, PMDA STED)
- Traceability Matrix, Gap Analysis, Risk Assessment exports

### Compliance Features
- **Electronic Signatures**: 21 CFR Part 11 / EU Annex 11 compliant with real identity verification, re-authentication for signatures, and 15-minute verification window
- **Audit Trail**: Automatic event logging on all CRUD operations, full timeline with diffs, signatures, CSV/PDF export. Server-backed append-only audit log in PostgreSQL.
- **Change Control**: Configurable per vertical (auto-revert on change, approval workflows)
- **Evidence Management**: Attach evidence files to requirements, tests, and CAPA records with completeness tracking
- **Risk Assessments**: Persisted risk assessment entities with full lifecycle and audit trail
- **CAPA Records**: Durable CAPA records with lifecycle states (open -> investigation -> in_progress -> verification -> resolved -> closed)

### Authentication, RBAC & SSO
- User registration and login with JWT-based authentication (24h access tokens + 7d refresh tokens)
- Server-side password hashing with bcrypt (12 rounds)
- **5 RBAC roles** with permission matrix:

| Role | View | Edit | Approve | Admin |
|------|------|------|---------|-------|
| admin | Yes | Yes | Yes | Yes |
| qa_manager | Yes | Yes | Yes | No |
| qa_engineer | Yes | Yes | No | No |
| auditor | Yes | No | No | No |
| reviewer | Yes | No | Yes | No |

- `requirePermission()` middleware for granular access control
- Signature verification with password re-authentication
- Session management with configurable timeouts
- Organization and workspace scoping for multi-tenant isolation
- **SSO (OIDC)**: Sign in with Okta, Azure AD/Entra ID, Auth0, Keycloak, or Google Workspace. Auto-provisioning on first login.

### Webhooks
- 14 events dispatched: requirement.created/updated/deleted, test.created/updated/failed, capa.created/status_changed, approval.requested/approved/rejected, signature.created, evidence.uploaded
- HMAC-SHA256 signing for payload verification
- CRUD + test endpoint for webhook management
- Settings UI with event selector and test button

### Integrations
- **Jira**: Connect to Jira Cloud, bidirectional sync (requirement to issue), import issues as requirements
- **GitHub**: Connect to repository, link PRs to requirements, import CI test results from GitHub Actions
- Tabbed Settings page: AI Providers, Webhooks, Integrations, SSO

### Docker Deployment
- Multi-stage `Dockerfile` (frontend build, server build, slim runtime)
- `docker-compose.yml` with app + PostgreSQL 16 services
- Health checks and named volumes for data persistence
- Static file serving in production mode

### Validation Package (IQ/OQ/PQ)
5 validation documents in `docs/validation/`:

| Document | Purpose |
|----------|---------|
| IQ (Installation Qualification) | 9 test steps verifying correct installation |
| OQ (Operational Qualification) | 18 test steps verifying correct operation |
| PQ (Performance Qualification) | Template for customer-specific validation |
| Compliance Statement | 21 CFR Part 11 (15 sections) + EU Annex 11 (17 sections) + GAMP 5 Cat 4 alignment |
| Traceability Matrix | 75 regulatory requirements mapped to QAtrial features + IQ/OQ/PQ test IDs |

### Backend Server (v4.0.0)
- **Hono** TypeScript-first HTTP framework on Node.js
- **PostgreSQL** database via **Prisma ORM v7** (25+ models)
- **JWT authentication** with access/refresh token pair
- **REST API** with 80+ endpoints across 28+ route files
- **Append-only audit log** in PostgreSQL with CSV export
- **CAPA lifecycle enforcement** with valid status transition checks and cascade triggers
- **Auto-generated sequential IDs** (REQ-NNN, TST-NNN) per project
- **Multi-user, multi-organization** support with workspace scoping
- **Webhook dispatch** with HMAC signing and retry tracking
- **SSO (OIDC)** with auto-provisioning
- **Docker** production deployment with static file serving
- **Vertical-depth routes**: complaints, suppliers, batches, training, documents, systems, impact, pms, udi, stability, envmon, auditrecords

### AI System Enhancements
- **JSON Schema Validation**: All AI responses validated against expected schemas with automatic retry/repair
- **Provenance Tracking**: Full audit trail of AI generations (model, parameters, tokens, timestamp, reviewer)
- **Re-run History**: Complete history of all AI-generated artifacts with comparison capability
- **Server Proxy Mode**: Server-side AI proxy (`POST /api/ai/complete`) keeps API keys off the client
- **9 AI prompt templates**: Test gen, risk classification, gap analysis, CAPA suggestion, executive brief, VSR, QMSR gap, requirement extraction, quality check

### External Connectors
- **Jira Cloud**: Bidirectional sync with REST API v3
- **GitHub**: PR linking and CI test result import via REST API v3
- Connector interface for Azure DevOps, GitLab, Veeva Vault, MasterControl, TrackWise, SharePoint, Confluence
- Field mapping configuration for bidirectional sync
- Sync status tracking and conflict resolution

### Internationalization (12 languages)
English, German, French, Spanish, Italian, Portuguese, Dutch, Japanese, Chinese (Simplified), Korean, Hindi, Thai

35+ locale directories prepared. Language selector in header with instant switching.

### Theming
Light and dark mode with full design system (CSS custom properties, Tailwind tokens).

## Tech Stack

See the **Technology** table above for the full stack. Key dependencies:

| Category | Packages |
|----------|----------|
| **Frontend** | React 19, TypeScript 5.9, Vite 8, Tailwind CSS 4, Zustand 5, TanStack Table v8, Recharts 3, react-i18next, Lucide React |
| **Backend** | Hono, @hono/node-server, Prisma v7, bcryptjs, jsonwebtoken, uuid |
| **Database** | PostgreSQL 16 (via Prisma ORM, 45+ models) |
| **Realtime** | Server-Sent Events (SSE) for live updates + presence |
| **Testing** | Vitest, Testing Library |
| **Deployment** | Docker Compose (dev/prod), Helm chart (Kubernetes) |
| **Integrations** | Jira Cloud REST API v3, GitHub REST API v3, SAP QM, LabWare LIMS |

## Project Structure

```
QAtrial/
├── server/                          # Backend server
│   ├── index.ts                     # Hono server entry point (port 3001)
│   ├── prisma/
│   │   ├── schema.prisma            # PostgreSQL schema (25+ models)
│   │   └── prisma.config.ts         # Prisma 7 migration config
│   ├── generated/prisma/            # Generated Prisma client
│   ├── middleware/
│   │   └── auth.ts                  # JWT auth + RBAC + permission middleware
│   ├── services/
│   │   ├── audit.service.ts         # Append-only audit logging
│   │   └── webhook.service.ts       # Webhook dispatch with HMAC signing
│   └── routes/
│       ├── auth.ts                  # Register, login, refresh, me
│       ├── projects.ts              # Project CRUD
│       ├── requirements.ts          # Requirement CRUD + auto seqId
│       ├── tests.ts                 # Test CRUD + auto seqId
│       ├── capa.ts                  # CAPA CRUD + lifecycle enforcement + cascade triggers
│       ├── risks.ts                 # Risk CRUD + auto scoring
│       ├── audit.ts                 # Read-only audit queries + CSV export
│       ├── users.ts                 # User management (admin)
│       ├── evidence.ts              # Evidence attachment endpoints
│       ├── approvals.ts             # Approval workflow endpoints
│       ├── signatures.ts            # Electronic signature endpoints
│       ├── export.ts                # CSV/JSON export
│       ├── import.ts                # CSV import with auto-detect + mapping
│       ├── ai.ts                    # Server-side AI proxy
│       ├── sso.ts                   # OIDC SSO (discovery, redirect, callback)
│       ├── webhooks.ts              # Webhook CRUD + test endpoint
│       ├── auditmode.ts             # Read-only audit mode link generation
│       ├── dashboard.ts             # Server-side dashboard analytics
│       ├── complaints.ts            # Complaint management + investigation workflow
│       ├── suppliers.ts             # Supplier quality scorecards + audit scheduling
│       ├── batches.ts               # Electronic batch records + e-signature release
│       ├── training.ts              # Training management (LMS-lite)
│       ├── documents.ts             # Document lifecycle management (SOP versioning)
│       ├── systems.ts               # Computerized system inventory (GAMP 5)
│       ├── impact.ts                # Live impact analysis (req/test graph chains)
│       ├── pms.ts                   # Post-market surveillance + PSUR assembly
│       ├── udi.ts                   # UDI management + GUDID/EUDAMED export
│       ├── stability.ts             # Stability study manager (ICH Q1A)
│       ├── envmon.ts                # Environmental monitoring + excursion detection
│       ├── auditrecords.ts          # Audit management + findings tracker
│       └── integrations/
│           ├── jira.ts              # Jira Cloud bidirectional sync
│           └── github.ts            # GitHub PR linking + CI import
├── src/
│   ├── ai/                          # AI system
│   │   ├── types.ts, provider.ts, client.ts, validation.ts, proxy.ts
│   │   └── prompts/                 # 9 AI prompt templates
│   │       ├── generateTests.ts     # Test case generation
│   │       ├── riskClassification.ts # Risk severity/likelihood
│   │       ├── gapAnalysis.ts       # Regulatory gap analysis
│   │       ├── executiveBrief.ts    # Executive compliance brief
│   │       ├── capaSuggestion.ts    # CAPA suggestion
│   │       ├── vsrReport.ts         # Validation Summary Report
│   │       ├── qmsrGap.ts           # QMSR gap analysis
│   │       ├── reqExtraction.ts     # Requirement extraction
│   │       └── qualityCheck.ts      # Requirement quality check
│   ├── templates/                   # Template composition
│   │   ├── types.ts, registry.ts, composer.ts
│   │   ├── packs/                   # 4 Compliance Starter Packs
│   │   │   └── index.ts
│   │   ├── verticals/               # 5 industry vertical templates
│   │   ├── modules/                 # 15 quality module definitions
│   │   └── regions/                 # 6 country + EU base + overlays
│   ├── connectors/                  # External QMS/ALM connector interfaces
│   ├── store/                       # 20 Zustand stores (client-side state)
│   ├── i18n/                        # i18next configuration
│   ├── hooks/                       # Custom hooks
│   ├── lib/                         # Constants, ID generator, approval helpers, apiClient
│   │   └── apiClient.ts             # Authenticated API fetch wrapper (Bearer token injection)
│   ├── types/                       # All TypeScript types (50+ types)
│   ├── components/
│   │   ├── layout/                  # AppShell
│   │   ├── wizard/                  # 7-step setup wizard (Step 0: compliance pack)
│   │   ├── requirements/            # Requirements table + modal
│   │   ├── tests/                   # Tests table + modal
│   │   ├── dashboard/               # 14+ dashboard components
│   │   ├── ai/                      # AI panels (test gen, risk, settings, quality check)
│   │   ├── reports/                 # Report generator + preview
│   │   ├── audit/                   # Audit trail, signature modal, audit mode, share link
│   │   ├── import/                  # Import wizard + export panel
│   │   ├── settings/                # Tabbed settings (AI, webhooks, integrations, SSO)
│   │   ├── complaints/              # Complaint intake, investigation, trending dashboard
│   │   ├── suppliers/               # Supplier scorecards, audit scheduling
│   │   ├── batches/                 # Electronic batch records, step execution
│   │   ├── training/                # Training plans, courses, compliance dashboard
│   │   ├── documents/               # Document lifecycle, SOP versioning
│   │   ├── systems/                 # Computerized system inventory
│   │   ├── impact/                  # Live impact analysis, what-if
│   │   ├── pms/                     # Post-market surveillance
│   │   ├── udi/                     # UDI management
│   │   ├── stability/               # Stability study manager
│   │   ├── envmon/                  # Environmental monitoring
│   │   ├── auditrecords/            # Audit management, findings tracker
│   │   └── shared/                  # Shared components
│   └── public/locales/              # 12 complete translation files
├── docs/                            # Documentation
│   └── validation/                  # IQ, OQ, PQ, Compliance Statement, Traceability Matrix
├── Dockerfile                       # Multi-stage production build
├── docker-compose.yml               # App + PostgreSQL deployment
├── .env.example                     # All configuration variables
├── package.json
├── tsconfig.json
├── vite.config.ts                   # Build config with manual chunks
└── vitest.config.ts                 # Test runner configuration
```

**250+ TypeScript source files · 45+ database models · 100+ API endpoints · 40+ route files · 80+ frontend components · 9 AI prompt templates · 12 translation files (500+ keys each) · 5 validation documents · Helm chart for Kubernetes**

## Installation

### Option 1: Docker (Recommended for Production)

```bash
git clone https://github.com/MeyerThorsten/QAtrial.git
cd QAtrial

# Copy environment template and configure
cp .env.example .env
# Edit .env to set JWT_SECRET, AI provider keys, SSO config, etc.

# Start QAtrial + PostgreSQL
docker-compose up

# Access at http://localhost:3001
```

Docker Compose starts the app and a PostgreSQL 16 database with health checks, named volumes for persistent data and uploads.

### Option 2: Frontend Only (Demo/Standalone Mode)

```bash
git clone https://github.com/MeyerThorsten/QAtrial.git
cd QAtrial
npm install
npm run dev
```

The frontend dev server starts on `http://localhost:5173`. In this mode all data is stored in `localStorage`.

### Option 3: Full Stack (Frontend + Backend, Local Development)

```bash
git clone https://github.com/MeyerThorsten/QAtrial.git
cd QAtrial
npm install

# 1. Install and start PostgreSQL (if not already running)
#    macOS: brew install postgresql && brew services start postgresql
#    Linux: sudo apt install postgresql && sudo systemctl start postgresql

# 2. Create the database
createdb qatrial

# 3. Set environment variables
export DATABASE_URL="postgresql://localhost:5432/qatrial"
export JWT_SECRET="your-secret-key-change-in-production"

# 4. Generate Prisma client and push schema
npm run db:generate
npm run db:push

# 5. Start the backend server (port 3001)
npm run server:dev

# 6. In another terminal, start the frontend (port 5173)
npm run dev
```

### Running the Backend

The backend runs on `http://localhost:3001` and exposes a REST API under `/api/`.

```bash
# Start backend with auto-reload on file changes
npm run server:dev

# Or start without watch mode
npm run server

# Verify the server is running
curl http://localhost:3001/api/status
# => {"status":"ok","version":"3.0.0","uptime":...,"database":"connected"}
```

**Available backend scripts:**

| Script | Description |
|--------|-------------|
| `npm run server` | Start the backend server |
| `npm run server:dev` | Start with file watching (auto-reload) |
| `npm run db:generate` | Generate Prisma client from schema |
| `npm run db:migrate` | Run Prisma migrations |
| `npm run db:push` | Push schema directly to database |
| `npm run db:studio` | Open Prisma Studio GUI for database browsing |

**Environment variables (see `.env.example` for full list):**

| Variable | Default | Description |
|----------|---------|-------------|
| `DATABASE_URL` | `postgresql://localhost:5432/qatrial` | PostgreSQL connection string |
| `JWT_SECRET` | `qatrial-dev-secret-change-in-production` | Secret for signing JWT tokens |
| `VITE_API_URL` | `http://localhost:3001/api` | API base URL for the frontend |
| `AI_PROVIDER_TYPE` | (none) | Server-side AI provider: `anthropic` or `openai` |
| `AI_PROVIDER_URL` | (none) | Server-side AI provider base URL |
| `AI_PROVIDER_KEY` | (none) | Server-side AI provider API key |
| `AI_PROVIDER_MODEL` | (none) | Server-side AI provider model name |
| `SSO_ENABLED` | `false` | Enable OIDC SSO |
| `SSO_ISSUER_URL` | (none) | OIDC issuer URL (e.g., Okta, Azure AD) |
| `SSO_CLIENT_ID` | (none) | OIDC client ID |
| `SSO_CLIENT_SECRET` | (none) | OIDC client secret |
| `SSO_CALLBACK_URL` | `http://localhost:3001/api/auth/sso/callback` | OIDC callback URL |
| `SSO_DEFAULT_ROLE` | `qa_engineer` | Default role for SSO-provisioned users |

## Setup Wizard (7 steps)

0. **Compliance Pack** -- Select a pre-configured compliance starter pack (FDA CSV, EU MDR, FDA GMP, ISO 27001+GDPR) or "Start from Scratch"
1. **Country** -- Select jurisdiction (37 countries)
2. **Industry Vertical** -- Select GxP domain (optional)
3. **Metadata** -- Project name, description, owner, version
4. **Project Type** -- Software, Embedded, QMS, Validation, Clinical, Compliance, Supplier Quality
5. **Quality Modules** -- Select composable quality controls
6. **Preview** -- Review and customize generated requirements + tests

## AI Provider Configuration

Go to Settings > AI Providers tab to configure LLM providers:
- Anthropic (Claude)
- OpenAI-compatible (GPT-4o, OpenRouter, Ollama, etc.)
- Multiple providers with purpose-scoped routing
- Token usage tracking
- Server-side proxy mode for secure API key management

## Documentation

- [User Guide](docs/USER-GUIDE.md) -- Complete end-user documentation
- [Architecture](docs/ARCHITECTURE.md) -- Technical architecture overview
- [Developer Guide](docs/DEVELOPER-GUIDE.md) -- How to extend QAtrial (add countries, verticals, languages)
- [API Reference](docs/API-REFERENCE.md) -- REST API, stores, hooks, utilities, type definitions
- [Regulatory Reference](docs/REGULATORY-REFERENCE.md) -- Standards and frameworks by country and vertical

## Contributing

QAtrial is open source and welcomes contributions. See the [Developer Guide](docs/DEVELOPER-GUIDE.md) for how to add countries, verticals, modules, languages, and AI prompts.

## License

This project is licensed under the [GNU Affero General Public License v3.0](LICENSE) (AGPL-3.0).

You are free to use, modify, and distribute this software. If you modify QAtrial and provide it as a service over a network, you must make your modified source code available under the same license.

QAtrial

QAtrial 최신버젼 다운로드

오늘의 추천 프로젝트

Was this content helpful?

Recent Feedback

QAtrial

QAtrial 최신버젼 다운로드

오늘의 추천 프로젝트

Was this content helpful?

Recent Feedback

Download README