QUMAS DocCompliance

QUMAS DocCompliance™ is an off-the-shelf, web-based regulatory content management system that ensures enterprise-wide consistency and compliance. The QUMAS eDMS enables organizations to create, manage, and securely store documents, using built in password policies to protect against unauthorized access. It contains full support for Electronic Signatures as per FDA 21 CFR Part 11 requirements.

DocCompliance, will provide you with: 
  • An easy to use Interface for viewing, accessing and printing controlled content
  • Full document Lifecycle management from creation, to archival
  • Simultaneous collaboration by multiple authors and reviewers
  • Document approval in compliance with 21 CFR Part 11 and Annex 11, Electronic Signature and Audit Trail
  • Searching, reporting and dashboards

QUMAS DocCompliance, will insure that ONLY the currently approved version of the applicable form will be provided and will enable you to:

  • Manage the development and approval of forms electronically and automatically
  • Issue forms to be filled in and eventually archived in the system   
  • Issue forms to be used and archived off the system
  • Reconcile issued forms with returned forms
  • Identify forms issued but not returned
  • Deal with form version change
  • Overcome commonly reported auditing issues

Key Features

  • Role Based Electronic Signatures

  • Workflow & Configuration Management

  • Advanced Lifecycle Management

  • Automated Notification & Distribution

  • Read & Understood

  • Comprehensive, Independent Audit Trail

  • Point-in-Time reporting

  • Hardcopy management

Creating and Managing R&D Documents with QUMAS DocCompliance: from Submissions through to Archiving

QUMAS provides a complete, end-to-end Enterprise Scanning Solution to address scanning requirements across the Life Science Industry when making the move from paper to electronic. The transition towards E-Archives starts with using an industry standard electronic document management system (eDMS) that communicates with an archival function or can be equipped to communicate with separate archival technology. Download this white paper to learn more.