Complaint Process Package

QUMAS offers a number of Packaged Solutions providing
pre-defined and pre-tested configurations of Document
content management or Process management for specific,
common industry problems. This Package addresses the
business process management requirements of a Complaint
process. The pre-defined configuration supports the
electronic capture, management, and reporting of Complaint
occurrences, root cause analysis, and follow up CAPAs, as
necessary.

Package features

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 also contains the following pre-defined configurations and professional services.

1) 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

2) 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)

3) Professional services including full package installation, delivery of end-user training and train-the-trainer training

4) A professional services review once the system has been in production use for at least three months

Complaint overview

A Complaint process is initiated following receipt of a complaint. It captures the key details of the complainant and the problem either with product or documentation to be routed for analysis. A decision can be made and recorded on the need to return samples. During analysis, further information / investigation can be sought before a response is defined including whether a CAPA is required.

Package benefits

The Complaint Process Package design enables authorized users to create and contribute to electronic complaint forms to document the investigation, report and propose resolution actions, and manage the review and approval with 21 CFR Part 11 compliant electronic signatures.

The execution of actions is automatically monitored for effectiveness and routed to QA for approval before closure. All actions are captured in the audit trail. Benefits also include:

• Availability – central common repository for all instances
• Security – forms don’t get ‘lost in the mail’
• Legibility – electronic rather than hand written forms
• Accessibility – ability to search for trends, previous occurrences, etc
• Consistency – single repeatable process, generation of consistent output
• Accountability – 21 CFR part 11 compliant signatures and audit trail, reports and analysis possible

Additional options

In addition to the out-of-the-box elements of this Package, clients have the option to purchase further options such as:

• Additional training days (end user and / or system administrator)
• Additional specific configuration (together with the required documentation, tests, and training)
• Integrations to other systems
• Custom reports
• Computer-based training

System requirements

• Two servers (database server and application server) for two environments (test environment and production environment)
• Servers can either be physical or virtual hardware
• Detailed guidance on system specifications is available
• Servers can be shared for multiple QUMAS packages