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Non Conformances

Xybion provides a complete non-conformance 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/preventive actions to prevent the repetition of these occurrences in the future.

The eQCM-XD 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-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 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, Documentum and others to ensure compatibility with most systems environments.

The key benefits of our overall solution are:

  • 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
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