The Future of
Pharmacovigilance is Here
Transforming Drug Safety with AI-Powered Automation & Compliance-Driven Innovation
HAROM Safety Vault: A Comprehensive & Intelligent Pharmacovigilance Solution Ensuring Global Regulatory Compliance, Efficiency, and Accuracy.
HAROM Safety Suite VaultNext-Gen Pharmacovigilance Intelligence
A Fully Integrated, AI-Powered Safety Database for End-to-End PV Operations
HAROM Safety Vault is more than just a database—it's an intelligent, automated safety solution designed to meet global regulatory requirements while enhancing operational efficiency and compliance.
100% Regulatory Compliance
with ICH, FDA, EMA, MHRA, CDSCO, WHO & More
Smart Case Processing
with real time validations
Advanced Security
Customization, and Real-Time Compliance Tracking
Unparalleled Security & Compliance
Ensuring the Highest Standards in Data Security & Regulatory Adherence
Advanced encryption protocols protect all data at rest and in transit
Regular security audits and penetration testing ensure system integrity
Comprehensive audit trails for all system activities
Advanced Two-Factor Authentication
Fully secure login process to protect sensitive data and user access.
Intelligent Duplicate Search
Dual-mode search (Quick & Expert) for 100% accuracy in detecting duplicate cases.
Global Compliance
Adheres to ICH E2B, 21 CFR Part 11, GVP, ISO GXP, GAMP-5, and other international standards.
Automated Efficiency & Seamless Case Management
Smarter, Faster & AI-Driven Case Processing for Maximum Efficiency
Smart Autofetch & Worklists
Intelligent automation that streamlines your workflow by effectively managing ICSR distribution, reconciling data, and managing tasks based on predefined rules and logic driven prioritization.
Instant Database Manual Access
Access comprehensive database documentation and real-time guidance without leaving your workflow. Get immediate answers to queries and procedural questions.
Integrated LMS Navigation
Access training materials and learning resources directly from the database itself.
In-System IT Support
Request technical assistance, configuration changes, and user management directly from within the application. No need to switch contexts or use separate systems.
Streamlined Workflow Automation
See how HAROM's automation capabilities transform your case management process
AI Processing
Smart Routing
Data Integration
Automated Actions
Dynamic Dashboards & Robust Administration
Real-Time Insights, Performance Tracking & Customizable Administration
Track compliance, case counts, billing, and KPIs with visually engaging graphs & analytics.
Data-Driven Decision Making
Transform raw data into actionable insights with real-time analytics and customizable reports.
Streamlined Administration
Simplify complex administrative tasks with intuitive interfaces and automated workflows.
Enhanced User Experience
Boost productivity with personalized dashboards and task management tools.
Effortless Data Entry & Validation
AI-Driven Accuracy & Streamlined Case Documentation
Intelligent Data Entry System
AI-powered validation ensures accuracy and compliance
Quick Entry Form
Instantly generate case IDs with real-time validation.
Intelligent Real-Time Validation
Error-free data entry with built-in logic.
Auto-Structured Data Organization
Automatically organizes captured information in a chronological, regulatory-compliant format.
AI-Powered Automation & Language Capabilities
Harnessing AI for Smart Translations, Text-to-Speech & Automated Narratives
Auto Language Detection & AI Translation
Instantly translates event descriptions & reporter comments without third-party dependence.
Automated Calculations
AI-driven listedness, case priority, and regulatory due date computations.
Narrative Autofetch & Formatting
Structured data extraction for well-formatted, grammar-optimized narratives.
AI-Powered Text-to-Speech
Enhances narrative accuracy and finalization speed.
Compliance-Driven Case Processing & Reporting
Seamless Reporting, Audit Trails & Global Regulatory Compliance
Comprehensive Case Revision History
Tracks every workflow change or case update.
Structured Reporting Forms
Ensures accurate, standardized CIOMS & regulatory reports.
Detailed Audit Panel
Full transparency & traceability of user actions.
Automated Report Scheduling
Enables seamless electronic submissions to regulatory bodies.
E2B R3 Case Import & Multi-Country ICSR Processing
Ensures global reporting compliance.
Flexible XML Generation
Supports R2 & R3 XML file creation based on regional regulations.
Advanced Pharmacovigilance Intelligence
Empowering Smarter Safety Decisions with AI-Driven Insights
PBRER/PSUR Line Listing Generation
Automates aggregate report compilation based on Data Lock Points (DLPs).
AI-Driven Signal Detection
Ensures unbiased signal identification & risk mitigation.
Robust User Management System
Configurable role-based access control for enhanced security.
Unmatched Regulatory Compliance & Data Integrity
Your Trusted Solution for Global Compliance & Audit Readiness
100% Regulatory Compliance
Meets ICH E2B, GVP, 21 CFR Part 11, ISO GXP, and GAMP-5 guidelines.
Complete Audit Trail & Traceability
Every system action is logged for full transparency.
Centralized ICSR Repository
A single, unified platform for all PV processes with complete data integrity.
Transform Your Pharmacovigilance with AI Automation
See HAROM Safety Vault in action—book a demo or request a proposal to streamline your PV operations.