Deviation Process Package

QUMAS Deviation Process Package

The Deviation Process Package offers the QUMAS ProcessCompliance application, together with pre-defined configuration to manage deviations 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
  • Integration with QUMAS DocCompliance

The Deviation Process Package also contains the following pre-defined configurations and professional service

ProcessCompliance configuration, designed specifically for change control management, including:

  • 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 - Appropriate user selection from pre-defined roles per task
  • Pages of pre-defined mandatory and optional fields to capture the information, analysis and decisions
  • Dynamic forms with inline help that guide users to provide the information needed

Documentation

  • Design Document detailing the pre-defined configuration
  • Client-specific Pick list values document
  • 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

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 Deviation Process Package Datasheet.