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.
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.
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.
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
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.
