# VIGIA

## Docs

- [Backup & Restore](https://mintlify.wiki/LuisCastilloCruz/VIGIA/admin/backup-restore.md): Database backups, data export/import, and recovery procedures for VIGIA
- [System Configuration](https://mintlify.wiki/LuisCastilloCruz/VIGIA/admin/configuration.md): Environment variables, system settings, and integration configuration for VIGIA
- [Multi-Tenant Architecture](https://mintlify.wiki/LuisCastilloCruz/VIGIA/admin/multi-tenant.md): Database isolation, tenant provisioning, and client management in VIGIA
- [User Management](https://mintlify.wiki/LuisCastilloCruz/VIGIA/admin/user-management.md): Manage users, roles, permissions, and employee records in VIGIA
- [Authentication Endpoints](https://mintlify.wiki/LuisCastilloCruz/VIGIA/api/authentication/login.md): API endpoints for user authentication, token management, and password operations
- [Authentication Overview](https://mintlify.wiki/LuisCastilloCruz/VIGIA/api/authentication/overview.md): Learn how to authenticate with the VIGIA API using JWT tokens and role-based access control
- [Permissions & Access Control](https://mintlify.wiki/LuisCastilloCruz/VIGIA/api/authentication/permissions.md): Understanding role-based access control (RBAC) and permission management in VIGIA
- [Export Formats](https://mintlify.wiki/LuisCastilloCruz/VIGIA/api/documents/export.md): Export ICSR cases and documents in multiple formats including DOCX, PDF, and Excel
- [Document Management Overview](https://mintlify.wiki/LuisCastilloCruz/VIGIA/api/documents/overview.md): API endpoints for managing pharmacovigilance documents, templates, and versions
- [Digital Signatures](https://mintlify.wiki/LuisCastilloCruz/VIGIA/api/documents/signatures.md): Add and manage digital signatures with OTP verification for document authentication
- [Document Upload & Management](https://mintlify.wiki/LuisCastilloCruz/VIGIA/api/documents/upload.md): Create, upload, and manage pharmacovigilance documents with version control
- [ICD-11 Search API](https://mintlify.wiki/LuisCastilloCruz/VIGIA/api/icd11/search.md): Search and retrieve ICD-11 diagnostic codes using WHO's official API with automatic token management and release fallback
- [Create ICSR Case](https://mintlify.wiki/LuisCastilloCruz/VIGIA/api/icsr/create-case.md): Create a new Individual Case Safety Report with patient, product, and event information
- [Manage Adverse Events](https://mintlify.wiki/LuisCastilloCruz/VIGIA/api/icsr/events.md): Add, update, and manage adverse events for ICSR cases with MedDRA coding support
- [ICSR Followup Communications](https://mintlify.wiki/LuisCastilloCruz/VIGIA/api/icsr/followup.md): Manage followup communications with reporters via email, SMS, and WhatsApp
- [List ICSR Cases](https://mintlify.wiki/LuisCastilloCruz/VIGIA/api/icsr/list-cases.md): Retrieve a paginated list of ICSR cases with filtering and search capabilities
- [ICSR API Overview](https://mintlify.wiki/LuisCastilloCruz/VIGIA/api/icsr/overview.md): Complete API reference for managing Individual Case Safety Reports in VIGIA
- [Update ICSR Case](https://mintlify.wiki/LuisCastilloCruz/VIGIA/api/icsr/update-case.md): Update an existing ICSR case with modified patient, product, or event information
- [IPS Calendar Management](https://mintlify.wiki/LuisCastilloCruz/VIGIA/api/ips/calendar.md): Manage scheduled IPS reports through the calendar system
- [Create and Manage IPS Reports](https://mintlify.wiki/LuisCastilloCruz/VIGIA/api/ips/create-report.md): Endpoints for creating, updating, and managing IPS reports
- [IPS Data Sources](https://mintlify.wiki/LuisCastilloCruz/VIGIA/api/ips/data-sources.md): Manage literature references and data sources for IPS reports
- [IPS Reports Overview](https://mintlify.wiki/LuisCastilloCruz/VIGIA/api/ips/overview.md): API endpoints for managing Periodic Safety Update Reports (IPS) in VIGIA
- [MedDRA Search API](https://mintlify.wiki/LuisCastilloCruz/VIGIA/api/meddra/search.md): Search and suggest MedDRA terms across the full hierarchy (SOC, HLGT, HLT, PT, LLT) with AI-powered extraction and synonym expansion
- [Extract Structured Data](https://mintlify.wiki/LuisCastilloCruz/VIGIA/api/nlp/extract-data.md): Extract structured pharmacovigilance data from unstructured text using NLP and pattern matching
- [Translate Text](https://mintlify.wiki/LuisCastilloCruz/VIGIA/api/nlp/translate.md): Translate text between languages using Google Translate API via deep-translator
- [Process Document with OCR](https://mintlify.wiki/LuisCastilloCruz/VIGIA/api/ocr/process-document.md): Extract text from PDF documents and images using Optical Character Recognition
- [Products API Overview](https://mintlify.wiki/LuisCastilloCruz/VIGIA/api/products/overview.md): Manage pharmaceutical products, including registration details, technical datasheets, and bulk import operations
- [Global Data Sources](https://mintlify.wiki/LuisCastilloCruz/VIGIA/api/surveillance/global-sources.md): Query regulatory agencies directly: FDA, EMA, DIGEMID, and VigiAccess
- [Surveillance API Overview](https://mintlify.wiki/LuisCastilloCruz/VIGIA/api/surveillance/overview.md): Monitor global pharmacovigilance databases and regulatory agencies with automated scraping, filtering, and reporting
- [Schedule Management](https://mintlify.wiki/LuisCastilloCruz/VIGIA/api/surveillance/schedule.md): Configure automated CRON-based surveillance scraping and manage execution schedules
- [Adverse Event Reporting](https://mintlify.wiki/LuisCastilloCruz/VIGIA/features/adverse-event-reporting.md): MedDRA coding, causality assessment with Karch-Lasagna and French algorithms, and comprehensive event documentation
- [Document Management](https://mintlify.wiki/LuisCastilloCruz/VIGIA/features/document-management.md): Digital signatures, document templates, version control, and regulatory document generation with PDF preview
- [ICSR Management](https://mintlify.wiki/LuisCastilloCruz/VIGIA/features/icsr-management.md): Comprehensive Individual Case Safety Report management with full lifecycle tracking, duplicate detection, and regulatory compliance
- [IPS Reports (PSUR)](https://mintlify.wiki/LuisCastilloCruz/VIGIA/features/ips-reports.md): Periodic Safety Update Reports generation with automated literature search, case aggregation, and benefit-risk assessment
- [Surveillance](https://mintlify.wiki/LuisCastilloCruz/VIGIA/features/surveillance.md): Global pharmacovigilance monitoring across FDA, EMA, DIGEMID, and VigiAccess with automated alerts and reporting
- [Case Evaluation](https://mintlify.wiki/LuisCastilloCruz/VIGIA/guides/case-evaluation.md): Severity assessment, urgency classification, and product assignment workflows for ICSRs
- [Case Intake](https://mintlify.wiki/LuisCastilloCruz/VIGIA/guides/case-intake.md): Multi-channel case ingestion workflows including web forms, email, WhatsApp, and OCR processing
- [Causality Assessment](https://mintlify.wiki/LuisCastilloCruz/VIGIA/guides/causality-assessment.md): Karch-Lasagna and Ficha Técnica (FT) algorithm workflows for determining product-event relationships
- [Followup Management](https://mintlify.wiki/LuisCastilloCruz/VIGIA/guides/followup-management.md): Automated followup scheduling, message tracking, and missing data request workflows
- [Generating Reports](https://mintlify.wiki/LuisCastilloCruz/VIGIA/guides/generating-reports.md): IPS/PSUR generation, DIGEMID exports, and regulatory document workflows
- [Installation Guide](https://mintlify.wiki/LuisCastilloCruz/VIGIA/installation.md): Complete installation and deployment guide for VIGIA pharmacovigilance platform
- [Introduction to VIGIA](https://mintlify.wiki/LuisCastilloCruz/VIGIA/introduction.md): Comprehensive pharmacovigilance platform for adverse event reporting, ICSR management, and IPS report generation
- [Audit Trail Module](https://mintlify.wiki/LuisCastilloCruz/VIGIA/modules/audit-trail.md): Comprehensive logging, compliance tracking, and change history for regulatory adherence
- [Bibliographic Search Module](https://mintlify.wiki/LuisCastilloCruz/VIGIA/modules/bibliographic-search.md): Integrated search across PubMed, SciELO, PMC, and LILACS for pharmacovigilance literature review
- [Ingestion Module](https://mintlify.wiki/LuisCastilloCruz/VIGIA/modules/ingestion.md): Multi-channel adverse event report ingestion system with email polling, web forms, WhatsApp integration, and OCR processing
- [OCR & NLP Module](https://mintlify.wiki/LuisCastilloCruz/VIGIA/modules/ocr-nlp.md): AI-powered text extraction, entity recognition, and translation for adverse event reports
- [Training Module](https://mintlify.wiki/LuisCastilloCruz/VIGIA/modules/training.md): Certification programs, attendance tracking, AI-generated materials, and automated certificate generation for pharmacovigilance teams
- [Quick Start Guide](https://mintlify.wiki/LuisCastilloCruz/VIGIA/quickstart.md): Get VIGIA up and running in minutes with Docker Compose
- [DIGEMID Integration](https://mintlify.wiki/LuisCastilloCruz/VIGIA/regulatory/digemid.md): Peruvian regulatory authority integration for product lookups and RAM exports
- [EMA Integration](https://mintlify.wiki/LuisCastilloCruz/VIGIA/regulatory/ema.md): European Medicines Agency safety alerts and regulatory communications
- [FDA Integration](https://mintlify.wiki/LuisCastilloCruz/VIGIA/regulatory/fda.md): US FDA Adverse Event Reporting System (FAERS) integration and medical device recalls
- [VigiAccess Integration](https://mintlify.wiki/LuisCastilloCruz/VIGIA/regulatory/vigiaccess.md): WHO global pharmacovigilance database access and signal detection