The core of an electronic QMS
The modules of the CANEA ONE platform can be freely combined and supplemented as needed. They are: CANEA Document, CANEA Process, CANEA Workflow, CANEA Strategy, and CANEA Project.
For a company in the life science industry, the importance of GDP (Good Documentation Practices) should not be underestimated. The Document module manages all stages of a document from creation, review and approval to publication, version management, and final archiving. These functions, combined with built-in compliance functionality such as electronic signatures, are essential for a life science company to meet the regulatory requirements of authorities and customers. CANEA Document ensures that your documents are compliant and accessible, and that the organization is always ready for inspection.
Once a company understands how an eQMS works, it quickly realizes the benefits of mapping its processes to understand HOW the documents should be managed. What are the processes and where do the different documents fit in? This is where CANEA Process comes into play. The module uses process modelling, that is mapping and visualization of processes. It helps the company to identify processes and activities that ensure quality. And to identify who is responsible for what.
One system for complete management
With documents and processes in place, it becomes natural to manage entire work flows such as CAPAs, customer complaints and deviation & change management in the same system. With CANEA Workflow, you can digitize and streamline case flows to ensure that documentation, investigations and transfers of information, processes & documents are done correctly and to the right people. In addition, you get an overview of all cases in real time. For example, when handling CAPAs (Corrective and Preventative Actions) in life science companies, you want to make sure that cases are not lost or forgotten, something that the workflow module ensures. The workflow module is also useful for managing risks and audits.
Life sciences companies that use and combine these three modules will have a strong eQMS foundation for their quality assurance.
From a regulatory approach to a more holistic one
However, you can go further than just meeting regulatory requirements. With CANEA ONE, you can develop both your organization and your business. The CANEA Strategy module helps to structure and activate the company's strategy. The balanced scorecard model, which defines the key objectives and metrics of the strategy, can be linked to the various processes. Questions such as how well the company is performing and whether it is delivering on the metrics, or whether there are problems with any of the processes, can be answered using the strategy module. And the case and process modules allow you to take the short- and long-term actions required to deliver according to set goals and metrics.
The CANEA Project module enables life science companies to efficiently run and manage individual projects, as well as monitor, control and prioritize between different project portfolios. With all project information in one place, employees have a common workspace for both accessing information and customizing workflows. The strategy and project tools provide the organization with a powerful platform for business management, from which everyone benefits.
Other parts of the company will realize that they also need to manage their documents or develop them for decision support or supplier management. In other words, the business moves from using CANEA ONE as an eQMS for one part of the organization to using it as a system that supports the whole company.
Uncomplicated and cost-effective integration
CANEA ONE modules are easy to maintain. You don't have to worry about coding but can configure and modify as needed. Plus, you can add new features, users, and licenses as your needs change, giving you full control over your system. This makes CANEA ONE a future-proof and flexible solution as easy to use as a license key.
And because it saves on configuration, management, and consultancy, when you change or update the system yourself after installation and commissioning, the modules are cost-effective. Given the long lifespan of the solution, this translates into significant savings while keeping the system up to date.
One customer story among many
XVIVO is a company dedicated to extending the time that all major organs - lung, heart, liver, and kidney - can exist ex vivo, that is, outside the body. This makes more organs available for transplantation and allows them to be transported longer distances.
"CANEA ONE is easily accessible, and the information is easy to find, but it depends on how you set up the system. CANEA has laid a very good foundation with a functioning structure, which we have built on. Then you must be prepared for regulations to change. This happened, for example, with the introduction of the MDR. As a small company, we didn't want to be so micromanaged, but that's a need that has changed as we've grown. A system has to be able to grow with the company and CANEA ONE has done that."
Mari Isberg, QA Manager at XVIVO Perfusion AB
Do you also want a modern eQMS and a more complete overview of your business? Learn more about how CANEA ONE solutions can optimize your business management.
