QMS

Verifarma's QMS (Quality Management System) is a validated, cloud-based platform designed for pharmaceutical laboratories and life sciences organizations. It centralizes quality management processes — including deviations, CAPAs, audits, complaints, change control, and documentation — into a single platform, providing full traceability and supporting regulatory compliance across Latin America, Europe, and other markets.

The QMS module is part of Verifarma Integrated Solutions (VIS), a broader pharmaceutical quality suite that also includes LIMS, RIMS, and Pharmacovigilance modules. The platform is built specifically for the pharmaceutical industry and is designed to operate in regulated, high-compliance environments.

Core Quality Management Capabilities

• Deviation and CAPA Control: Supports structured registration, investigation, and management of quality deviations, with tools to implement corrective and preventive actions (CAPA) aimed at continuous process improvement.
• Audit Management: Allows planning, execution, and documentation of both internal and external audits from a single platform, including tracking of findings and preparation for regulatory inspections.
• Complaints and Non-Conformances: Centralizes the recording and follow-up of complaints and non-conformances, ensuring analysis, resolution, and complete traceability for each case.
• Change Control: Manages and documents changes to processes, procedures, or systems, including impact assessment, approval workflows, and traceability.
• Action Plan Monitoring: Tracks the progress of corrective and preventive actions, monitoring deadlines, responsible parties, and outcomes.
• International Regulatory Compliance: Supports compliance with GAMP 5, FDA 21 CFR Part 11, ISO 9001, and ISO 27001, facilitating regulatory audits and validations.

Platform Features and Controls

• Electronic signature and Audit Trail functionality.
• Cloud-based solution with a focus on data integrity.
• Complete information traceability throughout all processes.
• System of notifications and alerts to support timely action.
• Paperless operation for reduced administrative overhead.
• Remote access from any location via an intuitive interface.
• 24/7 technical support.
• Cross-functional platform connecting multiple areas of the organization.

Regulatory and Validation Standards

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

AI Integration

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

Pharmaceutical Quality Suite — Related Modules

• LIMS (Laboratory Information Management System): Digitizes assays, samples, results, and reports with data integrity and full traceability.
• RIMS (Regulatory Information Management System): Centralizes management of regulatory registrations, submissions, and deadlines.
• Pharmacovigilance: Provides a validated, auditable solution for managing pharmacovigilance processes in line with international regulations, with a focus on patient safety and data integrity.

Verifarma reports over 16 years of experience supporting life sciences companies with traceability and compliance requirements. The QMS platform is used by more than 2,000 companies and is available with regional support across Spain, Argentina, and Mexico.