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 and 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.