Regulatory, Compliance and Quality Management Solutions for Pharmaceutical and Biotechnology Organizations


A cloud-based solution for Enterprise Quality Management and Quality Process Management

QUMAS EQMS is a cloud-based solution for Enterprise Quality Management and Quality Process Management that delivers comprehensive regulatory, quality and compliance management capabilities on one platform. The solution enables organizations to standardize and automate business processes that manage the collection, tracking and analysis of information and the resolution of related issues.

QUMAS EQMS has been designed to be compliant with FDA 21 CFR Part 11 including Electronic Signatures and immutable Audit Trails. The modern and intuitive user interface makes user adoption easy and fast. Deployment in the cloud minimizes Total Cost of Ownership (TCO) and scales with your company as your business and partner ecosystems grow. QUMAS EQMS is a flexible, scalable solution that delivers built in SOP (Standard Operating Procedure) and content management with all quality management processes for CAPAs, deviations, audits, validation, customer complaints and other investigational processes including multi-site change control. The system manages the entire range of quality content and processes with one unified solution ensuring SOPs are updated when impacted by a Deviation or CAPA, all within one regulatory record. The integration and extensive analytical capabilities for Quality provided by the Dassault Systèmes 3DEXPERIENCE platform allow users to obtain detailed trending and analysis, enabling them to identify trends, improve manufacturing processes and protect brand integrity.

Customers reported:

  • 80% reduction of approval times
  • >1575 hours of time savings of per year
  • 6.7 Mio € cost savings per year

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