QUMAS CAPA Process Package

The CAPA Process Package offers the QUMAS ProcessCompliance application, together with predefined configuration to manage corrective and preventive actions 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 CAPA Process Package also contains the following pre-defined configurations and professional services:

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 CAPA Process Package Datasheet.