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Digital QMS for Medical Devices
Implement a Digital Quality Management System in your organization to improve efficiency, compliance and overall product quality.
As a Medical Devices company, you help improve health and quality of life by innovating and accelerating high-quality research.
Implementing a Quality Management System, like ISO 13485, helps you to organize and link numerous processes.
In BizzMine you can easily digitize and automate these quality processes: Document Control (SOP), Management of Technical Files, Internal and External Audit Management, Risk Management, Corrective and Preventive Action (CAPA), Non-conformance Management, Post-Market Surveillance, Complaint Management, Incident Management (Vigilance), Calibration Management, Management of Change (MoC), Training Management, Design Control.
With BizzMine, we feel that we have a secure and homogeneous environment to maintain, order, and standardize our ISO documents. The software really helped us get through our process of becoming ISO certified in a short time and with less work.
With BizzMine you have validated QMS software according to GAMP5 standards.
These certifications can help you improve overall performance, eliminate uncertainty, and widen market opportunities.
The validation of your Quality Management System can be easy if you rely on our eQMS prebuilt validated processes.
And as your business grows, so must your quality management. A digital QMS can scale to meet increasing documentation, processes and requirements.
The BizzMine workflow module has made our CAPA and MoC processes ‘paperless’ and compliant with the requirements of 21 CFR Part 11.
You are in good company
Audit Management
BizzMine helps you to better organize and follow up your internal and external audits.
Training Management
BizzMine helps you to better manage and control all data on training and competencies.
Complaints Management
Track, investigate, and correct your customer and supplier complaints.
Calibration Management
BizzMine is the perfect application to plan, organize and analyze all calibration processes.
Document Control
Centralized management of SOPs, manuals, work instructions and other documents.