Quality Management Software
Xybion’s eQCM™ is a comprehensive quality management software solution that enables Enterprise Quality and Compliance Management. The platform delivers powerful web-based capabilities that facilitate organizational compliance with regulatory guidelines such as ISO 9001, ISO14001 GxP, FDA 21 CFR Part 11, financial reporting and governance regulations (SOX, CA Bill 198), and other industry standards and risk-based regulations. The solution is designed for maximum flexibility and is easily adapted to your organization’s unique quality business processes.
The core functionality includes a unique, flexible process control engine that helps global organizations effectively automate, manage and control compliance and quality process flows, such as, risk management, corrective and preventive actions (CAPA), nonconformances, customer complaints, audit management, training and competency management, incident management, and more. eQCM™ consists of a suite of modularized components which can be added to a core implementation as the enterprise needs grow and change.
Key features include:
- Core Quality Management Platform – eQCM™ enables organizations to configure mission-critical quality management processes that may involve documents, tasks, and workflows. This flexible process approach enables users to configure the platform to support changes in process over time without the need for software customization.
- Seamless Content Management Integration – Content and document control are essential to good governance and compliance. eQCM™ ensures that vital quality and compliance documentation is stored in a controlled, secure environment. The platform is a robust document management system that can be used as a stand-alone system or integrated with leading enterprise content management technologies such as EMC/Documentum, Open Text, and Microsoft SharePoint.
- Integrated Compliance Processes – integrated compliance processes allow the organization to track all or a subset of activities occurring in the organization. As a modular platform, you can choose the functions you need and choose to scale-up as your business needs evolve.
- By combining powerful business intelligence capabilities, enterprise content management, and quality management functions, eQCM™ helps organizations achieve sustained compliance with ever-changing regulations. In addition, it also increases efficiencies and supports collaboration by allowing organizations to manage and control key content while managing risks across multiple domain areas. As a highly configurable solution, eQCM™ delivers value out of the box without expensive customization, minimizing total cost of ownership over time.
Modules of the eQCM Quality Management System
- CAPA Management
- Internal Controls
- Enterprise Risk Management
- Quality Management Process Management
- Audit Management
- Competency Management
- Document Management
- SOP and Process Controls
- Quality Management Reporting