Pharmacovigilance

Verifarma Farmacovigilancia (FVG) is a pharmacovigilance management system designed for the pharmaceutical industry. It enables pharmaceutical laboratories to register, monitor, and analyse adverse events in a centralised platform, ensuring data traceability, regulatory compliance, and patient safety. The system connects all stakeholders involved in the process — from initial report reception through to final validation — within a secure, auditable environment validated according to GAMP 5, ISO 9001, and ISO 27001 standards.

The platform is part of Verifarma's broader Pharmaceutical Quality Suite, which also includes modules for quality management (QMS), laboratory management (LIMS), and regulatory affairs (RIMS). Verifarma has over 16 years of experience supporting life sciences companies with traceability and compliance across Latin America, Europe, and other markets, with more than 2,000 companies using its solutions.

Core Capabilities

• Centralised registration and monitoring of adverse events with full traceability of all information
• Detailed tracking of actions taken on each case, with automatic audit trail generation
• Collaborative workflows connecting pharmacovigilance, quality, and regulatory affairs teams
• Integrated document management for regulatory process documentation, reports, and updates
• System of notifications and alerts to support timely follow-up on cases

Compliance and Validation

• Validatable under GAMP 5 Category 4 guidelines
• Compliant with FDA 21 CFR Part 11 for electronic records and digital signatures
• Aligned with EU Annex 11 requirements
• Certified under ISO 9001 (quality management) and ISO 27001 (information security)
• Supports GS1 standards, with compliance since 2008
• Electronic signature and audit trail functionality to support data integrity requirements

Operational Features

• Cloud-based deployment with a focus on data integrity
• Paperless operation to reduce manual processes and associated costs
• Remote access from any location via an intuitive interface
• Cross-functional platform connecting multiple areas of the organisation
• 24/7 technical support

AI Capability

• Includes integration with Vera, Verifarma's AI component, which converts quality data into actionable information to improve operational efficiency and control

Verifarma FVG is deployed as a cloud solution and is designed to adapt to evolving regulatory requirements. The platform is suitable for pharmaceutical companies operating under international regulatory frameworks and is positioned as part of a broader integrated suite covering critical areas of the pharmaceutical quality system. Support is available in Spain, Argentina, and Mexico.