Nonconformances

Xybion provides a complete nonconformance software module as part of its eQCM® XD Quality Management software solution. Global regulatory requirements 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 strategy for nonconformances and develop Corrective and Preventive Actions to prevent the repetition of these occurrences in the future.

The eQCM XD Nonconformance Management software 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 XD through 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 XD nonconformance module can replicate your workflow, recording, record keeping, and reporting needs.

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

eQCM XD IT Governance Software Solution – Effective Risk and Control (GRC)

The eQCM XD IT Governance module allows organizations to manage IT governance within the organization by managing two critical components; the monitoring and assessment of IT objectives, including the risks and controls established to ensure effective governance, and the capability to manage and monitor IT changes. With eQCM XD IT Governance, the various framework’s such as COBIT can be modeled in the system and assessments run to determine the effectiveness of reaching the control objectives. Issues and corrective actions can be effortlessly initiated and managed. eQCM XD IT Governance also allows IT managers to consistently follow best practices to initiate an IT change request, follow a risk-based approach to assess the change impacts, create action plans, obtain the appropriate approvals and sign-offs, and provide communication and collaboration throughout all stages of the change cycle. 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 XD 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 XD is seamlessly integrated with standard enterprise technologies including Microsoft, Oracle, EMC/Documentum and others to ensure compatibility with most systems environments.

Key Features:

  • Enterprise Platform as a Service
  • 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

Other Modules:

CAPA MANAGEMENT

AUDIT MANAGEMENT

QUALITY MANAGEMENT REPORTING

INTERNAL CONTROLS

COMPLAINT MANAGEMENT

IT GOVERNANCE

INCIDENT MANAGEMENT

DOCUMENT MANAGEMENT

LEARNING MANAGEMENT

CHANGE MANAGEMENT

PROGRAMS AND OBJECTIVES