QUMAS Quality Assurance Documents Package

The Quality Assurance Documents Package offers the QUMAS DocCompliance application, together with predefined configuration to support the lifecycle management of Quality Assurance documentation in highly regulated industries.

This Package contains advanced, out-of-the-box EDMS functionality including the following features:

Audit Trails, Reporting, Workflows, Messaging, Auto-Rendering, Version Control, Lifecycle Management, Full-text Searching, Role-based Security/Permissions, 21 CFR Part 11 Electronic Signatures.

The Quality Assurance Documents Package also contains the following pre-defined configurations and professional services:

DocCompliance configuration, designed specifically for QA use, based on business fundamentals widely accepted in industry

• 5 pre-defined GxP document types, including the following:
  • Procedures
  • Methods
  • Specifications
  • Regulatory
  • General
• 5 pre-defined workflows to ensure best practice content progression and management
• Supporting Configuration for Quality Assurance Management

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) plus 90-days access to QUMAS' Computer-based Training (CBT) Series
• 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 Quality Assurance Documents Package Datasheet.