We take the time allocated for Quality Management and Technical file document preparation processes and gift it to you!
Quality management in the medical device industry is vital for the safety of patients and the performance of products. QMexCOPAN , developed in cooperation with EXCOPAN and BTS , is an innovative quality management system that allows you to manage all quality management processes on a single platform.
QMexCOPAN is a software that facilitates compliance with legal requirements, designed modularly for the purpose of operating quality processes electronically, integrated with each other and with other business applications, complying with the requirements of 21 CFR Part 11 and can be used through internet browsers validated according to GAMP 5.
Cost Advantage
Time and human resources, paper, printing materials, physical archive.
Data integrity
Secure data storage and monitoring in compliance with ALCOA+ requirements.
Easy Reporting
Easy reporting with PDF, Excel and Dashboard features.
Time saving
Monitoring whether actions are carried out correctly and on time, ease of auditing, fast document preparation, approval and distribution.
Data Security
Customer-specific, isolated on the MS Azure SaaS platform;
Database
Storage Services
App Services
Full Compliance with Regulations
It is designed to be 100% compliant with international regulations such as ISO 13485, FDA QSR, MDR, IVDR. Thanks to instant update capabilities, you can instantly integrate changes in legislation into the system.