Risk Management
Active dashboards are used for visual display of the Risk Management File
From the dashboard it is possible to immediately identify the risk class of the product or service. It is also possible to see in which phase of the supply chain the risk is registered, and trend on data on one or multiple products and services.
Hit the Risk Management ‘Sweet Spot’
Avoid spending too much time on risk and risk mitigation so the product never gets introduced to the market, and be careful not spending enough time, which will generate too any complaints and incidents. This is the Risk Management “Sweet Spot”.
Link Risk with Requirements
It is possible to link risk with requirements and other business processes. In this way it is visible to stakeholders where the risk in the idea phase, design & development, production, servicing, maintenance the risk is identified. This is a mandatory regulatory requirement, but also just good business practice.
Compare Risk with Non-conformity
This is the truly interesting part to be able to monitor for risk measures against nonconformities. Remember risk is not a non-conformity, risk is a potential non-conformity. And how will it be tracked if the risk management effort has been effective? How do we know if we hit the “Sweet Spot”? In MyBlueLabel it is possible to compare and investigate this data with dashboard functionality.
Enterprise Risk Management
Get buy-in from business. A risk management file is a regulatory requirements, but it is only truly valuable if it can be used by business people. Therefore it can be a good idea to enrich the data with risk to operations, strategy, environment social and governance risk. This is easily done in MyBlueLabel.
Track to completion
With MyBlueLabel Risk Management is possible to link Risk Control with the identified risk. In this way, when a Risk Control is closed, then the dashboard on the risk is updated. This means that within a very short time it is possible to know if the risk has been mitigated or still needs attention to be closed out.
Modules in the QMS
MyBlueLabel has a suite of modules to support the full ecosystem of processes to comply with regulations and international standards. The modules are integrated or can work as standalone modules
For more information: Book Demo
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Everything documented in one place. Ready for both internal and external audits.
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Organizes projects using templates, automates timeline tracking, and ensures transparency and traceability.
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Quickly share knowledge and lessons learned within the Organization.
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For creating, editing, signing, and storing all project documents in a single location.
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Providing Support for your hotline or helpdesks with a comprehensive overview.
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Ability to register and view all changes during projects and opreations.
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Controlled Versioning of Documentation, Code, and System Configuration.
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Provides the functionality of creating, investigating, tracking, and closing deviations for IT systems, processes, and/or procedures.
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Provides a template to assign actions to individuals in need of closing out an Incident or Deviation.
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Reviews and Approvals can be done instantly and online. Test execution is done electronically, and test evidence is captured within the system.
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The training can consist of written documentation, video or audio and will be completed with a “Read & Understood” procedure. If many users share the same role, training can be given in a “Classroom”.
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In situations where external users file a complaint about the system, product, or service, the complaint must be recorded and resolutions (CAPA) must be created and addressed.
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MyBlueLabel offers a basic CRM with customer tracking, segmentation, feedback collection, and personalized client interactions.
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MyBlueLabel enhances risk assessment, linking it to requirements, business processes, and enterprise strategies for effective mitigation.
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MyBlueLabel streamlines solution implementation by managing specs, linking requirements, minimizing documents, and enhancing traceability.
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Design Control facilitates locating requirements, aiding implementation, maintenance, and change management with ease.
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