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BIOVIA QUMAS

Cloud-based quality management and electronic document control for regulated industries, automating compliance processes and reducing approval times.

Solution by Dassault Systèmes
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Overview

BIOVIA QUMAS is a fully integrated, data-centric, cloud-based Quality Management solution developed by Dassault Systèmes, designed for organizations delivering products and services to customers and patients in regulated industries. It enables companies to automate quality processes, promote data integrity, reduce compliance risks, and achieve excellence in both quality and regulatory compliance.

At the heart of BIOVIA QUMAS are two core systems: the QUMAS EDMS (Electronic Document Management System) for data-centric documentation and content management, and the QUMAS EQMS (Enterprise Quality Management System) for quality process management. Both systems are accessible through the unified, user-friendly MyQUMAS interface, which supports real-time collaboration, task management, and eLearning capabilities. BIOVIA QUMAS is scalable and suitable for small to large enterprise implementations, with cloud deployment making it flexible for a wide range of organizational needs.

Core Capabilities

  • Fully integrated, cloud-based Electronic Document Management System (EDMS) for documentation and content management
  • Enterprise Quality Management System (EQMS) for end-to-end quality process management
  • Unified MyQUMAS interface providing a single point of access for all regulatory and quality content
  • Real-time collaboration and management of quality and regulatory content
  • Task creation and execution covering the full quality lifecycle — from incident logging through investigation, approval, and remediation
  • eLearning functionality enabling users to browse, view, mark documents as read and understood, and print and search content
  • Management of SOP updates driven by Deviations or CAPAs within one unified validated solution
  • Quality Intelligence capabilities for searching and analyzing quality data to support proactive quality decision-making

Regulatory Compliance Support

  • Designed specifically for regulated industries
  • Supports compliance with US FDA, EMA, and PMDA regulatory requirements
  • Reduces validation efforts required for system implementation
  • Decreases time and resources needed for inspections and audits

Reported Customer Outcomes

  • 80% reduction in approval times
  • 40% time improvement for First-to-File and First-to-Market processes
  • 98% cost reduction compared to traditional repositories with disconnected systems

BIOVIA QUMAS is deployed in the cloud, making it accessible and scalable for organizations of all sizes. It integrates seamlessly within the broader BIOVIA portfolio of solutions spanning research, development, quality, and manufacturing, and supports organizations seeking a single, validated platform to manage the full scope of their quality and compliance requirements.

Meta

Domain
Quality, Compliance & Regulatory
Subdomain
Quality Management System (QMS)
Software type(s)
Workflow Automation
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
BiotechCROMedical DevicesPharma
Development stage(s)
ClinicalManufacturingPost-Market & RWEPreclinical / Pre-Market
Target user(s)
Lab Manager / Core Facility ManagerQA / Regulatory AffairsIT / Systems Admin / Data Engineer
Compliance standard(s)
21 CFR Part 11GxP