QUMAS

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

QUMAS Overview

A cloud-based Quality Content Control solution for Enterprise Document Management

QUMAS is a fully integrated cloud-based solution for managing your quality data, documents and processes to achieve Compliance, Quality and Operational Excellence throughout the product lifecycle. More than 20 years of global experience in the space of quality, regulatory compliance, and document and process management are building the foundation for the QUMAS Quality Management offering.

The core of this offering is QUMAS EDMS for Quality Document and Content Management and QUMAS EQMS for Quality Process Management. This integrated solution allows organizations to automate quality processes , ensure data integrity, reduce compliance risks and to achieve Quality Excellence.

Developed for the highly regulated Life Sciences industry, the solution provides full security controls and compliance with the US Food & Drug Administration (FDA) 21 CFR Part 11 including Electronic Signatures and Audit Trail. Its inspection-readiness also helps organizations to run smooth inspections and to reduce overall audit times. The modern and intuitive user interface makes user adoption easy and fast, and cloud deployment minimizes Total Cost of Ownership (TCO). The system’s scalability makes it possible to adapt the solution from small to large enterprise deployments.

QUMAS users can expand the capabilities of their QUMAS Quality deployment with Quality Intelligence based on the Dassault Systèmes 3DEXPERIENCE platform. Quality Intelligence provides dedicated search and analytics capabilities for Quality content. This facilitates true end-to-end control and visibility while at the same time providing data integrity and a “Single Source of Truth” for all Quality data and content. This comprehensive and pro-active approach to Quality is well in-line with the FDA’s request that organizations should move from mere compliance to a “Culture of Quality.”

Customers reported:

  • 80% reduction of approval times
  • 40% time improvement for First-to-File, First-to-Market and Chemistry, Manufacturing and Control (CMC) approval
  • 30% cycle time reduction for documentation

QUMAS is designed and engineered to support compliance and to deliver real business value:

  • Compliance:
    Achieve data integrity with electronic signatures and immutable audit trails
  • Single-source-of-Truth:
    Leverage a single data repository to easily track, monitor, trend and report on quality performance information
  • Reduced inspection time and downtime:
    Provide immediate access to data and documents with hyperlinks
  • Minimal compliance efforts:
    Automate tasks and standardize controlled processes
  • Deviation tracking:
    Track actual performance against SOPs, identify deviations and manage related information in a single system
  • Change control:
    Manage CAPA investigations and conduct root-cause analysis to get accurate information and quickly make correct decisions
  • Low Cost-of-Ownership:
    Easily configure and deploy the QUMAS cloud-based solution, integrating without a heavy IT footprint
  • Productivity and efficiency:
    Automate and streamline processes, e.g., for Regulatory Submissions
  • Overview and control:
    Tailor analytics and dashboards to gain meaningful insights into quality data for impactful decision making
  • Shorter Time-to-Market:
    Accelerate approval cycles and reduce rework/recall rates
  • Culture of Quality:
    Adopt a comprehensive, data-centric approach to Quality

For more information about an even broader approach to Quality, please visit our Total Quality page to learn about how to leverage additional BIOVIA capabilities for Quality.

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