Xybion Corporation

Xybion provides a complete complaint management software module as part of its eQCM quality management suite. Customer complaints present unique challenges to manufacturers across multiple industry sectors. By nature, customer complaints represent dissatisfaction with either product quality or performance in a post-distribution environment. Valid complaints may lead to required changes in manufacturing product specifications or the costlier action of product recall.

The International Organization for Standardization (ISO) and the FDA’s Quality System Regulation (QSR) require well-established processes to effectively monitor and control customer complaints. To ensure effective governance and compliance, your complaint-handling system should not only collect feedback from unsatisfied customers, but deliver capabilities to effectively document the failure investigation process and link them to the appropriate corrective and preventive actions (CAPA).

Xybion’s eQCM Customer Complaint™ module is designed as part of an integrated GRC suite to efficiently document, manage and control customer complaints in compliance with current regulatory guidelines and best practices. At the heart of the eQCM Customer Complaint™ module is Xybion’s powerful workflow engine that allows organizations to document and automate critical business processes to ensure compliance and operational efficiency.

The eQCM Customer Complaint™ module provides the flexibility to manage customer satisfaction in a broader context. With the use of action plans, notifications, and customer satisfaction ranking criteria, the organization is able to monitor the customer satisfaction level, determine the potential impacts to the organization, and take the appropriate corrective or preventive action.

This powerful module delivers enhanced visibility to product or manufacturing challenges through key features such as customizable forms, communication management features and adaptable workflows that automatically trigger an investigation or corrective action based on user-defined criteria.

Xybion provides complete incident management software as part of its eQCM software.  The management of risk is at the heart of incident management.    Incident management transcends the mere ability to respond.  Effective incident management requires enterprise collaboration and communication to minimize risk and ensure sustained compliance.  Critical incidents resulting in injury, illnesses or loss of life can hamper productivity and impact the bottom line.  The impact of adverse incidents may have financial impacts, medical expenditures, and possible legal actions.  They can also negatively impact your corporate reputation, lower employee morale and result in potential disruptions in production.

The Occupational Safety and Health Administration require U.S. employers to maintain accurate records and make periodic reports on work-related deaths, and recordable injuries and illnesses.  The quality of these is of paramount importance for anyone who uses the resulting data. Problems with consistency, accuracy or completeness can compromise the data and reduce the quality of the decisions made on the basis of those data.

Xybion’s web-based Incident Management module can assist organizations in reducing profit losses due to unmanaged incidents and inadequate follow-up.  Through the configurable workflow engine, organizations can easily model their incident reporting, investigation, treatment, and corrective action processes within the organization.   The manager is also able to easily create your company’s first report forms in the system—without programming or knowledge of complex reporting technologies, allow appropriate oversight with approval and review sequences, and provide configurable notifications that provide the critical information to the right people without jeopardizing privacy requirements.  With the Processes-In-Control dashboard, the managers can see the status of current processes, identify bottlenecks and review critical indicators in order to optimize process performance.

The Xybion eQCM™suite delivers a comprehensive platform for GRC and quality management.  Our comprehensive solution includes embedded best practices and flexibility for deployment in any systems environment.  eQCM™is seamlessly integrated with standard enterprise technologies including Microsoft, Oracle, EMC/Documentum and others to ensure compatibility with most systems environments. 

The key benefits of our overall solution are:

• Enterprise Platform

• On-Premise, SaaS Deployment Options

• Advanced Integrated Technologies

• Flexible Process Control Engine

• Compliant With Current Regulatory Guidelines

• Compatible With OCEG GRC Framework

• Ensures Sustained Compliance and Governance

Xybion provides a complete non-conformance software module as part of its eQCM quality management software solution.  Global regulatory requirements madate include mandates to deal with products or raw materials that do not conform to product quality requirements.  Nonconforming products or materials could lead to costly rework and even product recall. These nonconformities increase the organization’s risk of adverse impacts to business continuity, customer relations, market reputation, or other areas.   Manufacturers across multiple industries must comply with guidelines such as cGMP, 21 CFR Part 820, ISO 9001, ISO 13485 and ISO 14001 which all include requirements for the management of nonconformances.

Continuous improvement is the foundation for good governance and management of long term risk.  Forward-thinking companies must have an effective strat of nonconformances and develop corrective/preventive actions to prevent the repetition of these occurrences in the future.

The eQCM nonconformance module allows companies to effectively automate and manage the full nonconformance process in a manner consistent with regulatory guidelines.   This module provides management of nonconformances in eQCM provides automated, web-based tools for managing materials, processes, components and products. Whether your organization manages defects, deviations, out-of-spec results or other types of issues, the integrated eQCM nonconformance module can replicate your workflow, recording, recordkeeping, and reporting needs.