Assuring Product Quality, Customer Satisfaction and Regulatory Compliance
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 offers two quality management options so you can apply the integrated solution that best meets your needs and budget:
Expandable ERP Integration for AssurX CATSWeb
Expandable’s integration with AssurX CATSWeb 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 CATSWeb 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 CATSWeb 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 CATSWeb, 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
Integration at key touch points between Expandable and CATSWeb maintains data integrity and provides reportable visibility of quality issues and details
See Expandable ERP
Integration
for AssurX
CATSWeb in the video demos.
Expandable Quality Management Module
Expandable's Quality Management module puts quality management functionality directly on the Expandable menu bar. With quality-related functions built directly into the Expandable ERP system, growing manufacturers can produce superior products by applying solid quality management principles all along the production cycle, from engineering change management through procurement and production to service and maintenance.
Expandable’s quality management module allows quality control documents, quality test results, certificates of compliance, QC release documents and MRB disposition to be attached to quality-related transactions. Documents can be retrieved for viewing or printing, but cannot be changed once attached to transactions in the database.
