QUMAS ProcessCompliance

QUMAS ProcessCompliance™ is the premier Enterprise Quality Management Solution (EQMS), delivering pre-configured best practice management of a wide range of compliance, quality and operational activities. This flexible, scalable QMS uniquely delivers built in SOP and content management with all quality management processes for CAPAs, planned and unplanned deviations, audits, validation, customer complaints, control of marketing timing incidents, AML and other events management processes and multi-site change control. No other QMS manages the entire range of quality content and processes in one unified solution, or can scale with your company as the business and partner ecosystem grows.

    "The fact that the products can be tied together to provide a linkage between documents and processes was a big factor in selecting ProcessCompliance," said Dawn Porter, Compliance Process Lead at Hollister Inc. "Also both products have the same look and feel so end user training was minimized."

A flexible, scalable and secure solution, QUMAS ProcessCompliance provides reliable workflow management and control, allowing each organization to map the system to its own specific processes and enhance both regulatory compliance and overall operational efficiency. Leveraging the latest relational database and Web technologies, QUMAS ProcessCompliance is seamlessly integrated with QUMAS DocCompliance to facilitate risk-based decisions and access to controlled documentation during all phases of process management.

Key Features:

  • Scalable, web-based solution
  • Comprehensive issue tracking - a fully closed-loop system drives issue resolution
  • Extensive reporting capabilities through integration with Crystal Reports
  • Seamless integration with all controlled documentation in QUMAS DocCompliance
  • Secure audit trail means the organization is always 'audit-ready'
  • Built-in electronic signatures, and compliance with predicate rule requirements for effective electronic records management
  • Flexibility and configurability - the solution adapts to existing structures, ensuring best practices are standardized enterprise-wide

If you need to get up and running within 30 days with a GAMP-certified approach, check out the QUMAS Packaged Solutions, which offer an off-the-shelf approach to Quality Management for:

Core Components:

  • A fully integrated data dictionary
  • Business rules engine
  • Configurable forms builder
  • Highly scalable workflow engine and reports