LIMS

Verifarma LIMS (Laboratory Information Management System) is a laboratory management solution designed for pharmaceutical laboratories. It automates, controls, and documents laboratory activities across the full sample lifecycle — from intake through results reporting — with the goal of reducing manual errors, improving response times, and maintaining data integrity in line with international regulatory requirements.

The platform is built specifically for the pharmaceutical industry and is validated for regulated environments. It integrates directly with Verifarma's broader Quality Suite, connecting laboratory workflows with quality management, regulatory affairs, and pharmacovigilance modules.

Core Functional Modules

• Routine Analysis: Supports quality control management through the definition of protocols and assays, assignment of analysts, and automated generation of Certificates of Analysis (COA).
• Stability Studies: Manages stability study programs, including definition of strategies and storage conditions, tracking of results over time, and generation of evolution reports.
• Sample Management: Controls the complete sample lifecycle through coding, traceability, location tracking, and automatic report generation. Integrates directly with the routine analysis, calculations, and stability modules.
• Analytical Calculations: Automates the verification and approval of analytical calculations, generates reports, and validates results automatically to support data integrity.

Control, Security, and Data Integrity

• Electronic signature and Audit Trail functionality.
• Cloud-based deployment with a focus on data integrity.
• Complete traceability of all information within the system.
• Notification and alert system for process monitoring.

Regulatory Compliance

• Compliant with FDA 21 CFR Part 11 for electronic records and signatures.
• Validatable under GAMP 5 – Category 4.
• Aligned with EU Annex 11 guidelines.
• Certified under ISO 9001 (quality management) and ISO 27001 (information security).
• Compliant with GS1 standards since 2008.
• Designed to adapt to evolving regulatory requirements.

Operational Benefits

• Paperless operation, reducing reliance on manual, paper-based processes.
• Faster access to laboratory information and improved process efficiency.
• Remote access from any location via the cloud platform.
• Intuitive interface designed for ease of use.
• 24/7 technical support.

AI Capability

• Verifarma's AI component, called Vera, integrates with the LIMS platform to convert quality data into actionable information, supporting operational efficiency and control.

Integration within the Verifarma Quality Suite

• QMS (Quality Management System): Manages deviations, CAPAs, audits, complaints, change control, and quality programs.
• RIMS (Regulatory Information Management System): Centralises management of regulatory registrations, submissions, and deadlines.
• Pharmacovigilance: Digitises and centralises pharmacovigilance management with auditable, collaborative processes.

Verifarma has over 16 years of experience supporting life sciences companies with traceability and compliance across Latin America, Europe, and other markets. The platform is used by more than 2,000 companies and is accessible via offices and support teams in Spain, Argentina, and Mexico.