RIMS

Verifarma RIMS (Regulatory Information Management System) is a validated platform designed for regulatory affairs teams in the pharmaceutical and life sciences industries. It centralises and controls all regulatory information related to products, supporting the management of health registrations, dossiers, renewals, and regulatory documentation with full traceability and global compliance.

The system is built to automate and standardise regulatory submissions and record management, improving operational efficiency and cross-functional collaboration across regulatory affairs, quality, production, and supply chain departments.

Core Regulatory Management Capabilities

• Manages the complete lifecycle of health registrations, including new registrations, renewals, extensions, and amendments.
• Maintains clear control and visibility over each regulatory file and its current status.
• Centralises all regulatory documents in a secure, validated platform with controlled access.
• Records every action and change within the system, ensuring data integrity and a complete audit history for each regulatory file.
• Supports collaborative participation from all areas involved in the regulatory process.

Control, Security, and Compliance Features

• Electronic signature and Audit Trail functionality.
• Cloud-based solution with a focus on data integrity.
• System of notifications and alerts for critical dates and deadlines.
• Compliant with FDA 21 CFR Part 11 requirements for electronic records and signatures.
• Validatable under GAMP 5 Category 4 guidelines.
• Designed to adapt to evolving regulatory requirements.
• Certified under ISO 9001 (quality management) and ISO 27001 (information security).
• Aligned with EU Annex 11 guidelines and GS1 standards.

Operational Efficiency

• Supports paperless operation, reducing reliance on physical documentation.
• Provides agile access to regulatory information, improving process speed.
• Remote access from any location via the cloud platform.
• Intuitive interface designed for ease of use within regulated environments.

AI Integration

• Includes integration with Vera, Verifarma's AI solution, which transforms quality and regulatory data into actionable information to improve efficiency and operational control.

Platform and Support

• 24/7 technical support available to users.
• Connects multiple organisational areas through a single transversal platform.
• Part of the Verifarma Pharmaceutical Quality Suite, which also includes QMS (Quality Management System), LIMS (Laboratory Information Management System), and a Pharmacovigilance Management System.

Verifarma has over 16 years of experience supporting life sciences companies with traceability and regulatory compliance across Latin America, Europe, and other markets. More than 2,000 companies use Verifarma solutions. The platform is available with regional support offices in Spain, Argentina, and Mexico.