Adverse event management
Providing a complete lifecycle
Provides the functionality of creating, investigating, tracking, and closing deviations for IT systems, processes, and/or procedures. Corrective Action / Preventive Action (CAPA) must be planned and approved before they are implemented to close out a Deviation.
Ensures full traceability
The Adverse event is linked to the portfolio, and at the same time linked back to the trigger of deviation and forward to the CAPA associated with the deviation.
This single solution ensures full traceability. The Deviation Management workflow within MyBlueLabel are as follows:
Raise Deviation – Observation, Investigation, Review Deviation (CAPA) Internal, Review Deviation (CAPA) Independent,
Approval for Realization, and Deviation Approved.
Document deviation
With the module your company can follow up and correct non-compliant incidents and activities. This could be procedures not being followed, changes made without change request or a system and/or associated component malfunctions.
Immediate action
The Root Cause analysis of the Deviation in place can enable immediate action on how to stop the deviation and continue production. Using Corrective Actions afterwards will ensure that the deviation is properly closed. Preventive Actions will ensure that the deviation will not be reoccurring.
Process optimization
Your company will achieve immediate insight, as the modules are interlinked. The quick identification of the flow, from what led to the deviation to the corrective action gives you a complete overview and enables a smooth remediation process.
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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