QUMAS Audit Process Package

The Audit Process Package combines the QUMAS ProcessCompliance application, together with pre-defined configuration to manage Audits 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 also contains the following pre-defined configurations and professional services:

• ProcessCompliance configuration, designed specifically for Audit 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 online help that guide users to provide the information needed
• Documentation
  • Design Document detailing the pre-defined configuration
  • Client-specific Picklist 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

Audit Overview

Two processes have been defined to support Auditing:

1. ‘Audited’ is to manage the investigation and resolution of issues arising from ‘being audited’.
2. ‘Auditing’ is for recording any findings, developing a report and reconciling the responses when performing an audit on somebody else.

Either process can be used for both internal and external use. Both processes allow the people carrying out the activity to capture data and then run a report to be sent to the other party (saving a copy in the process instance).

For more information download the QUMAS Audit Process Package Datasheet.