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eQMS 
  • eQMS is an electronic quality management system that automates and streamlines quality processes required for Medical Device development in medical device and system development companies. It enables centralized and efficient management and tracking of quality-related activities such as Document Control, Change Control, Training Management, and Supplier Management. 
  • It supports monitoring compliance with industry regulations (ISO 13485, FDA 21 CFR Part 820, CE MDR, etc.) and standards (IEC 62304, etc.), and provides technical services for early detection and resolution of potential issues. 정(ISO 13485, FDA 21 CFR Part 820, CE MDR, etc.)
eQMS Key Features  
  • Equipped with QMS support capabilities such as Document Control, Change Control, Training Management, Supplier Management, Design Control, Risk Management, Audit Management, Nonconformity Management, CAPA Management, and more.
✅ To establish a robust QMS, eQMS enforces CAPA, Change Control, Complaint Management, and Audit Management, and provides manuals, procedures, guidelines, and template sets aligned with IEC 62304, ISO 14971, ISO 9001, ISO 13485, and FDA 21 CFR Part 11.
✅ To enhance efficiency, eQMS centralizes documents, procedures, and guidelines required across development, production, testing, and validation.    
✅ Provides processes, document control, traceability, and audit functions to meet regulatory requirements and ensure compliance with international standards.
✅ Centralizes diverse quality-related documents and data generated within the organization, ensuring consistency and accuracy while enabling real-time tracking and analysis of quality metrics.
✅ Supports continuous quality improvement and institutionalization by collecting and analyzing quality data to identify root causes and drive corrective actions, regardless of user expertise.

eQMS

In Medical Device Development eQMS Implementation and Integrated Management of Development Work Products  
  • Teamer eQMS supports the digitization of paper documents required by ISO 13485, enabling the execution of a compliant quality management system. 
  • Integrated Management of Quality Documentation and Development: Quality management procedures based on ISO 13485 can be linked with software development process management as required by IEC 62304. 
  • Through dashboards based on various widgets, you can clearly monitor the status of tasks such as document approval, change management, CAPA, and audits.
  • With Teamer, CAPA Management for internal audits and corrective actions required by ISO 13485 and GMP can also be executed in eQMS.
Benefits of Using eQMS 
Provides features such as document workflows, QMS process support, electronic signatures, automated notifications, and real-time visibility of work progress.
✅ Authoring, editing, reviewing, approval, and archiving  

✅ Electronic signatures 

✅ Version management and access rights based on user roles 
✅ Tracking and managing quality events such as nonconformities, customer complaints, audit results, and CAPA
✅ QMS processes: training, change management, design control, risk management, equipment calibration, supplier management   
✅ Generate reports and analyze quality data to identify trends and areas for improvement
✅ Plan, schedule, execute, and document quality audits
✅ Ensure compliance with quality standards
eQMS Highlights 
  • Meets increasing demands for quality assurance, customer-centric production, and adaptation to changing standards and regulations. 
  • Applies technologies designed to minimize errors from traditional paper-based quality management systems and improve inefficient management methods. 
  • Connects all quality-related processes and data within an organization into a single system. 
  • Provides a centralized repository for all documents and data, simplifying business processes and workflows to enhance the efficiency of quality and compliance management.
eQMS
  • eQMS is an electronic quality management system that automates and streamlines quality processes required for Medical Device development in medical device and system development companies. It enables centralized and efficient management and tracking of quality-related activities such as Document Control, Change Control, Training Management, and Supplier Management. 
  • It supports monitoring compliance with industry regulations (ISO 13485, FDA 21 CFR Part 820, CE MDR, etc.) and standards (IEC 62304, etc.), and provides technical services for early detection and resolution of potential issues. 
eQMS 
Key Features 
  • Equipped with QMS support capabilities such as Document Control, Change Control, Training Management, Supplier Management, Design Control, Risk Management, Audit Management, Nonconformity Management, CAPA Management, and more. 

  To establish a robust QMS, eQMS enforces CAPA, Change Control, Complaint Management, and Audit Management, and provides manuals, procedures, guidelines, and template sets aligned with IEC 62304, ISO 14971, ISO 9001, ISO 13485, and FDA 21 CFR Part 11.  

 To enhance efficiency, eQMS centralizes documents, procedures, and guidelines required across development, production, testing, and validation.  

 Provides processes, document control, traceability, and audit functions to meet regulatory requirements and ensure compliance with international standards.  

 Centralizes diverse quality-related documents and data generated within the organization, ensuring consistency and accuracy while enabling real-time tracking and analysis of quality metrics.  

  Supports continuous quality improvement and institutionalization by collecting and analyzing quality data to identify root causes and drive corrective actions, regardless of user expertise.  

Integrated eQMS for MedTech
In Medical Device Development eQMS Implementation and Integrated Management of Development Work Products 
  • Teamer eQMS supports the digitization of paper documents required by ISO 13485, enabling the execution of a compliant quality management system.
  • Integrated Management of Quality Documentation and Development: Quality management procedures based on ISO 13485 can be linked with software development process management as required by IEC 62304.
  • Through dashboards based on various widgets, you can clearly monitor the status of tasks such as document approval, change management, CAPA, and audits.
  • With Teamer, CAPA Management for internal audits and corrective actions required by ISO 13485 and GMP can also be executed in eQMS. 
Benefits of Using eQMS 
  • Provides features such as document workflows, QMS process support, electronic signatures, automated notifications, and real-time visibility of work progress. 

 Authoring, editing, reviewing, approval, and archiving  

  Electronic signatures  

  Version management and access rights based on user roles  

  Tracking and managing quality events such as nonconformities, customer complaints, audit results, and CAPA  

 QMS processes: training, change management, design control, risk management, equipment calibration, supplier management  

  Generate reports and analyze quality data to identify trends and areas for improvement  

  Plan, schedule, execute, and document quality audits  

  Ensure compliance with quality standards  

eQMS
Highlights 
  • Meets increasing demands for quality assurance, customer-centric production, and adaptation to changing standards and regulations. 
  • Applies technologies designed to minimize errors from traditional paper-based quality management systems and improve inefficient management methods. 
  • Connects all quality-related processes and data within an organization into a single system. 
  • Provides a centralized repository for all documents and data, simplifying business processes and workflows to enhance the efficiency of quality and compliance management. 
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Teamer eQMS


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Roh Kyung Hyun
04559, 5F Pyeonggwang Building, 243 Toegye-ro, Jung-gu, Seoul (Chungmuro 5-ga 19-19)
+82-10-8337-9837
631-81-00287
www.vwaycorp.com
vway@vwaycorp.com

© VWAY All rights reserved

Representative

Roh Kyung HyunBusiness Registration Number
631-81-00287
Company Address
5th Floor, Pyeong-kwang B/D, 243, Toegye-ro, Jung-gu, Seoul, Republic of Korea
Website
www.vwaycorp.com
Telephone
+82-2-2285-6541
Representative Email
vway@vwaycorp.com

© VWAY All rights reserved