Inventory
Project
Configuration
Incident
Change
CAPA
Knowledge
TestVisual data
Each module has its own dashboard, which makes it easy to keep track of ongoing and closed activities. This brings a visual awareness of activities requiring an action. In addition it supports the periodic review and data analysis for continuous improvement of any system.
Project portfolio
MyBlueLabel dashboards are used for visual display of the project portfolio activities. From the dashboard you have the possibility to see which projects are on track, needs attention or are off track. By selection it is feasible to get the project status of the entire company or per organizations in one view.
Multi Dashboard (Critical-to- Quality Dashboard)
MyBlueLabel full quality ecosystem of all information obtained of the ‘critical to quality’ processes in one solution. You can display all information in one view; Project status, Incident Status, Change Status and Deviation status. With the drill-down functionality it can be listed at company level or down to each individual project serving the CEO, the Organisation Lead, or the Project Management Team.
MyBlueLabel Compliance
MyBlueLabel’s solution is based only on internationally recognized Quality Management standards. Combined with industry expertise in Life Science, Software Validation and Risk Management means that we can help you manage regulatory requirements from launching a new product to managing post-market activities.
ISO 9001 : 2015
ISO 13485 : 2016
ISO 14971 : 2019
EU MDR
FDA
Part 11 / Annex 11
GxP
Modules in MyBlueLabel QMS Software
MyBlueLabel offers a SaaS (Software as a Service) integrated Quality Management solution containing 12 modules, which can be individually enabled for your company’s specific need. The interface is simple to navigate and provides real-time key-metrics in all quality processes.
Inventory
Inventory Management provides you with an overview of the technical landscape in the entire company.
Document
Document Management gives you and your team the timesaving possibility to create, edit and store all the project documents.
Project
Project Management helps you organize your project portfolio based on predefined project plan templates.
Configuration
Configuration Management provides controlled version of the Code and Configuration of the system.
Incident
Incident Management serves as support to your hotline or helpdesk. Categorizing the incident helps trending on issues.
Change
Change Management gives you and your team the possibility to see all changes made during projects and operations.
Deviation
Deviation Management provides the functionality to create, track, monitor, and close deviations for IT systems.
CAPA
CAPA Management provides you with the template to assign actions to individuals needing to close out the Deviation.
Knowledge
Knowledge Management brings shared information and “lessons learned” into the organization with ease.
Training
Training Management provides the possibility to assign training based on organization and roles. It tracks the training completion progress throughout the company.
Test
Test Management gives you and your team the possibility to author, review, approve and execute testing activities electronically and instantly.
Complaint
Complaint Management enables registration and tracking of customer complaints for timely communication to ensure customer satisfaction.