Complaint Process Package

QUMAS Complaint Process Package

The Complaint Process Package combines the QUMAS best-in-class Process Management Application ProcessCompliance with a pre-defined configuration designed according to current best and common industry practices to manage Complaints in highly regulated industries. This Package contains advanced, out-of-the-box business process management functionality including the following features:

  • Data Dictionary
  • Configurable Forms Builder
  • Business Rules Engine
  • Workflow
  • Reporting
  • Audit Trails
  • Messaging
  • Role-based Security / Permissions
  • 21 CFR Part 11 Electronic Signatures
  • Integrated with QUMAS DocCompliance

This Package comes complete with the following pre-defined configurations and professional services:

ProcessCompliance configuration, designed specifically for Complaint management, including

  • Dynamic forms with inline help that guide users to provide the information needed
  • Pages of pre-defined mandatory and optional fields to capture the information, analysis and decisions
  • Appropriate user selection from pre-defined roles per task
  • Workflow of tasks from Initiation through Supervisor Approval, Team Selection, Impact Assessment, Evaluation, Action Approval, Execution and Monitoring of Actions, Effectiveness Review, and QA Follow-up

Documentation

  • Design Document detailing the pre-defined configuration
  • Client-specific Pick list values document (to be filled in by client and returned to QUMAS for inclusion in configuration prior to installation)
  • Validation Pack: IQ, PQ, Functional Specification, Design Specification, and Trace Matrix (OQ not required because this Package contains a pre-defined configuration)
  • End-user training course (PDF Guide)
  • System Access Plan (to be filled in by client and returned to QUMAS for inclusion)

Professional Services including full Package installation, delivery of End-user training and Train-the-Trainer training

A Professional Services Review once the system has been in production use for at least 3 months

For more information download the QUMAS Complaint Process Package Datasheet.