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


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

Electronic Content Control and Document Management are the cornerstones of Quality and Compliance. But static documents cannot fulfil the needs of a transforming industry. To truly leverage quality data and to adapt quality documentation to changing regulatory demands in an agile manner, organizations need to move from traditional document management to intelligent Quality Content Control.

QUMAS EDMS is a cloud-based Quality Content Control solution for Enterprise Document Management that delivers proven regulatory compliance practices for data and document control and related training across the business. The solution has been designed to be compliant with FDA 21 CFR Part 11 including Electronic Signatures and immutable Audit Trails. Policies, Standard Operating Procedures (SOPs), work instructions, manuals, files and reports are created and controlled in a dynamic way in compliance with global regulatory mandates. The modern and intuitive user interface makes user adoption easy and fast. Drag and drop of content like Word documents onto the user interface simplifies document creation. Deployment in the cloud minimizes Total Cost of Ownership (TCO) and scales with your company as your business and partner ecosystems grow. The solution’s advanced data-centric approach facilitates document creation, search and management.

Customers reported:

  • 98% cost reduction versus a traditional repository built on disconnected electronic systems
  • 75% faster implementation versus traditional repositories from design to production
  • 100% compliance compared with traditional repositories

QUMAS EDMS includes capabilities for:

  • Enterprise Content Management:
    Control the full ‘lifecycle’ of a document (or set of documents), from creation through the management of content editing, workflows for review and approval and hardcopy management to scheduled retention and retirement. The system is highly configurable to extend or modify document types and workflows to meet business requirements
  • Learning Management (LMS):
    Powered by NetDimensions, the system provides an automated process for compliance training and management or launching, tracking and managing interactive corporate compliance training
  • Document Control according to Industry Standards:
    Authoring and management of Policies, Standard Operating Procedures (SOPs), work instructions and manuals as well as for eCTD, non-eCTD and Regulatory Submissions for Regulatory Affairs, CMC (Drug Product and Drug Substance), Clinical, Nonclinical and Quality
  • Batch Data Management:
    Handle large quantities of documents efficiently with dedicated capabilities:
    • Enterprise Scanner
      Automated Scanning for converting paper archives to electronic documents stored in the Enterprise Document Repository as well as creating cover pages or printing batches of forms to be reconciled (and archived).
    • Document Transfer
      Automated batch load of multiple documents from different originating applications through the definition of metadata, ‘drag and drop’ a set of files from the file system.
    • Content Cache
      Storage of a local cache of frequently used documents for widely dispersed global deployments allowing for significant performance improvement.

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