CAPA management
Template to assign actions to individuals
MyBlueLabel CAPA Management provides a template to assign actions to individuals in need of closing out an Incident or Deviation.
CAPA workflow
There can be one or many Corrective Actions and Preventive Actions linked to a Deviation
The single CAPA action is assigned to a Task Owner and a due date is estimated. Every CAPA is accepted individually but is approved together with the associated Deviation. The CAPA is linked To the Deviation or Incident and each action can be linked to an activity closing for the CAPA action, i.e. a Change Request. The CAPA Management workflow within MyBlueLabel are as follows:
Create CAPA, Review Internal, Review Independent, Approval for Realization, and CAPA Accepted.
Corrective Action
Each corrective action will be tracked in the system. Each action will be approved and linked to an activity closing to ensure an optimum quality assurance of the proposed solution
Preventive Action
Preventive actions must be established in order to make sure the incident or deviation will not happen again. This activity is often associated with a gap in the procedures or processes and how they are implemented in the organization.
Controlled action
Having the full overview and control of actions will make it less complicated to implement and constantly improve harmonized and structured standard operations procedures throughout the company.
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
-
Everything documented in one place. Ready for both internal and external audits.
Read more -
Organizes projects using templates, automates timeline tracking, and ensures transparency and traceability.
Read more -
Quickly share knowledge and lessons learned within the Organization.
Read more -
For creating, editing, signing, and storing all project documents in a single location.
Read more -
Providing Support for your hotline or helpdesks with a comprehensive overview.
Read more -
Ability to register and view all changes during projects and opreations.
Read more -
Controlled Versioning of Documentation, Code, and System Configuration.
Read more -
Provides the functionality of creating, investigating, tracking, and closing deviations for IT systems, processes, and/or procedures.
Read more -
Provides a template to assign actions to individuals in need of closing out an Incident or Deviation.
Read more -
Reviews and Approvals can be done instantly and online. Test execution is done electronically, and test evidence is captured within the system.
Read more -
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”.
Read more -
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.
Read more -
MyBlueLabel offers a basic CRM with customer tracking, segmentation, feedback collection, and personalized client interactions.
Read more -
MyBlueLabel enhances risk assessment, linking it to requirements, business processes, and enterprise strategies for effective mitigation.
Read more -
MyBlueLabel streamlines solution implementation by managing specs, linking requirements, minimizing documents, and enhancing traceability.
Read more -
Design Control facilitates locating requirements, aiding implementation, maintenance, and change management with ease.
Read more