Assuring Product Quality, Customer Satisfaction and Regulatory Compliance

Quality Management

The quality imperative is a company-wide initiative, so Expandable takes an integrated approach to quality management that delivers enterprise-wide visibility of quality assurance data. With quality-related data accessible directly through Expandable ERP, you're able to transform your entire organization into a coordinated cross-functional quality team.

Integrated and Reportable

Expandable’s integrated approach makes quality-related data available over the complete range of Expandable reporting and monitoring features, including business intelligence, alerts, inquiries and decision support. Expandable's visibility of quality information helps you continuously improve product quality to sustain high customer satisfaction levels and maintain compliance with industry-related quality standards (ISO, FDA, QS-9000, and others).

Expandable ERP Integration for AssurX

Expandable’s integration with AssurX provides a complete platform for building quality management processes that can be configured to fit the specific business needs of companies operating under government and industry-regulated quality standards.

Expandable ERP Integration for AssurX includes an out-of-the-box startup configuration providing four core quality management functions:

  • Supplier quality
  • Manufacturing Non-conformance & Deviation
  • Customer complaints
  • Corrective and Preventive Action (CAPA)

Because AssurX is a core platform, medical device manufacturers can validate quality functions and processes to meet FDA compliance and other industry requirements.

With integration between Expandable and AssurX, data remains consistent between the two platforms, facilitating the full range of functions that can be added to the startup configuration as a company's quality management requirements grow, including:

  • Document Management
  • Change Control
  • Training Management
  • Device History and Batch Records
  • Audit and procedures management
  • Regulatory Reporting (including eMDR)
  • Compliance Management
AssurX ERP Integration

Integration at key touch points between Expandable and AssurX maintains data integrity and provides reportable visibility of quality issues and details

See Expandable ERP
Integration for AssurX
in the video demos.