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VIGIA Platform

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Welcome to VIGIA

VIGIA is a comprehensive pharmacovigilance platform designed for healthcare organizations, pharmaceutical companies, and regulatory agencies to manage adverse event reporting, Individual Case Safety Reports (ICSRs), and Periodic Safety Update Reports (IPS).

Quick Start

Get up and running with VIGIA in minutes

Installation Guide

Detailed setup instructions for development and production

API Reference

Complete API documentation for integrations

User Guides

Learn how to use VIGIA’s powerful features

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Key Features

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ICSR Management

Manage Individual Case Safety Reports with comprehensive data capture:
  • Patient information (demographics, medical history)
  • Adverse event details with MedDRA coding
  • Product information with normalization
  • Causality assessment (Karch-Lasagna, FT42)
  • Follow-up tracking and automated reminders
  • Duplicate detection and management

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IPS Report Generation

Automated Periodic Safety Update Report generation:
  • Template-based DOCX export using industry standards
  • Multi-source data aggregation (local + global surveillance)
  • Regulatory intelligence from EMA, AEMPS, FDA
  • Literature search integration (PubMed, SciELO, LILACS)
  • Benefit-risk analysis with AI assistance

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OCR & NLP Extraction

Intelligent document processing: 
# Example: OCR service with multi-format support
from app.services.ocr_service import ocr_file

# Extract text from PDF, images, or Office documents
text = ocr_file("/path/to/document.pdf")

# NLP extraction for adverse events
from app.services.openai_extractor import openai_extract_fields

extracted_data = openai_extract_fields(
    email_text=text,
    sender_email="[email protected]"
)

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Multi-Tenant Architecture

Secure tenant isolation with PostgreSQL: 
# Automatic tenant routing based on subdomain
# cliente1.vigia.com -> cliente1_db
# cliente2.vigia.com -> cliente2_db

from app.core.database import get_tenant_db

db = get_tenant_db(tenant="cliente1")

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Surveillance & Signal Detection

Real-time pharmacovigilance monitoring:
  • VigiAccess integration for global reporting trends
  • Automated literature surveillance
  • Signal detection algorithms
  • Custom alert configuration
  • Email notifications for critical events

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Platform Architecture

Backend

FastAPI + PostgreSQL
  • RESTful API with OpenAPI docs
  • SQLAlchemy ORM with Alembic migrations
  • Celery for background tasks
  • JWT authentication with role-based access

Frontend

React + Vite
  • Modern component architecture
  • CoreUI design system
  • React Router for navigation
  • Axios for API communication

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Technology Stack

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Backend Technologies

  • FastAPI: Modern Python web framework with automatic API documentation
  • PostgreSQL 15: Robust relational database with full-text search
  • SQLAlchemy: Python SQL toolkit and ORM
  • Pydantic: Data validation using Python type annotations
  • Celery: Distributed task queue for background jobs
  • Redis: Caching and message broker

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AI/ML Integration

  • OpenAI GPT-4: Advanced NLP for event extraction and analysis
  • Google Gemini: Alternative LLM for text processing
  • Tesseract OCR: Open-source OCR engine for document digitization
  • PyMuPDF: PDF text extraction and manipulation

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External Integrations

  • VigiAccess API: WHO global ICSR database
  • PubMed: Medical literature search
  • SciELO: Latin American scientific journals
  • LILACS: Health literature database
  • Regulatory APIs: EMA, AEMPS, FDA data sources

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Use Cases

  • Manage post-marketing surveillance programs
  • Generate IPS reports for regulatory submissions
  • Track adverse events across product portfolio
  • Automate follow-up communications
  • Integrate with existing safety databases
  • Centralized adverse event reporting
  • Patient safety monitoring
  • Clinical trial safety management
  • Regulatory compliance reporting
  • Quality management integration
  • National pharmacovigilance database
  • Multi-organization data collection
  • Signal detection and analysis
  • Regulatory decision support
  • Public reporting dashboards

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Security & Compliance

VIGIA implements industry best practices for healthcare data security:
  • JWT-based authentication with role-based access control (RBAC)
  • Multi-tenant data isolation at the database level
  • Comprehensive audit trails for all actions
  • HTTPS encryption for data in transit
  • Database encryption at rest
  • GDPR-compliant data handling

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Getting Started

Ready to start using VIGIA? Follow these steps:
1

Set Up Your Environment

Install Docker and Docker Compose, or prepare your local Python and Node.js environment.View Installation Guide →
2

Quick Start

Run VIGIA with Docker Compose and create your first ICSR in minutes.View Quick Start →
3

Explore the API

Discover VIGIA’s comprehensive REST API with interactive documentation.View API Reference →

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Community & Support

VIGIA is actively developed and maintained. For questions, issues, or contributions:
  • Documentation: You’re reading it!
  • API Docs: Available at http://localhost:8000/docs when running
  • GitHub Issues: Report bugs and request features
  • Email Support: Contact your administrator

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What’s Next?

Explore the documentation to learn more:

Quickstart

Get VIGIA running in 5 minutes

ICSR Management

Learn about case management

IPS Reports

Generate periodic safety reports

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