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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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Design Control

Effortlessly track and update impacted documentation

Automate traceability and ensure requirement coverage using MyBlueLabel’s module Design control

Easy traceability

Building an electronic traceability matrix is a major advantage and saves a lot of time instead of maintaining it manually on paper (or even electronic Paper). By using the modules in MyBlueLabel the Design Control will be automatically build while linking requirements to specification, and risk and test.

Easy traceability

With design control, it is easy to find a source of requirement. It will be useful during implementation but also later during maintenance and solution update. When a change is introduced the trace of impacted documentation/information will be easily identified and updated.

Always be in control.

When using mybluelabel design control, the coverage of requirements ensured. The system will notify when a requirement is not being implemented or linked to other information. In an audit situation, the solution will promote signs of control and integrity.

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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