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MyBlueLabel Compliance Services A/S
DTU Science Park
Agern Allé 5A
DK–2970 Hørsholm

contact@mybluelabel.com

+45 88 710 810

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Specification Management

Enhancing Project Efficiency and Quality Assurance

Requirements Specification, System Specification, all products, and services must be specifications in order to implement a successful solution. In MyBlueLabel we can break down the individual requirement for electronic tracking and traceability. In MyBlueLabel active dashboard it is possible to trend on data and drill down in areas of interest.

Requirements Linkage

By entering or uploading requirements and specifications into MyBlueLabel, the data can be linked to other data in MyBlueLabel. It is possible to link Requirements to Specification and to Risk and Test. Thereby an electronic traceability matrix is built. And the Users do not have to maintain yet another document.

Minimize number of documents

By Using MyBlueLabel Specification module, it is possible to minimize the number of document which need to be maintained in order to document keep objective evidence that the solution is fit for intended use. Often multiple documents must be maintained when a requirement is updated. This process can be improved with MyBlueLabel content (data) management.

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

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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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