Imagine a quality management system that you can easily maintain and update yourself, and at the same time, the system evolves in sync with your business. CANEA ONE's modular approach offers just that – a platform designed with powerful modules providing the building blocks to add on as your product and company grows. Particularly in the life science sector, keeping documents and processes up-to-date is often challenging to meet regulatory requirements. CANEA ONE's platform provides documentation, process, and workflow management expected by quality professionals – but it can also be integrated into the rest of the company as a business management system. Here's how it works.
Building the core eQMS
The CANEA ONE platform offers different modules which can be combined and supplemented when needed: CANEA Document, CANEA Process, CANEA Workflow, CANEA Strategy, and CANEA Project.
For a life science company, the importance of GDP (Good Documentation Practices) and Documentation Management cannot be understated. CANEA Document addresses all documentation stages: creation; review/approval; version management; publishing and lastly, retirement. This functionality together with built-in compliance features such as electronic signatures is essential for life science companies to adhere to FDA and related regulatory requirements. CANEA Document keeps your documents compliant and accessible at all times, and keeps you audit ready.
Once you start there, you realize that it would be good to map out your processes to understand HOW you need to manage the documents. What are the processes? Where do the different documents fit into the process? This is where CANEA Process comes in. It builds upon process modeling – the ability to map an visualize processes. This helps your company identify processes and activities to ensure quality. And identify who is responsible for what.
With documents and processes in place, a natural step is managing the whole workflow. With CANEA Workflow, you can digitalize and streamline processes to ensure that handover of information, processes and documents are done correctly and to the right people. In addition, you can digitalize an overview of processes in real-time and adapt them as needed. For example, when dealing with Corrective And Preventative Actions (CAPA) within life science companies, you want to ensure that cases do not get lost in the company; the Workflow module can help. The Workflow module is also useful to manage risks and audits.
Combining and leveraging these three modules gives you strong eQMS foundation for quality assurance within a life science company.
Download the E-book "Life Science eQMS" for more inspiration
From regulations to holistic business management
You can also use the CANEA ONE platform to go beyond meeting regulatory requirements to manage and grow your organization and business. The CANEA Strategy module helps structure and activate your strategy. The balanced scorecard model of defining your strategy's key objectives, targets and key performance indicators (KPIs) can be tied to your different processes. Questions such as "how are we performing, are we delivering on the KPIs, or are we having issues in one of the processes" can be answered with the help of the Strategy module. Using the Workflow and Project modules, allows you to take short and long term actions when not delivering according to KPIs.
CANEA Project enables life science companies manage effectively and execute single projects as well as monitor, control and prioritize multiple project portfolios. With all the project information in one place, colleagues have a one-stop-shop to access information and align ways of working. By adding strategy and project tools, you have a comprehensive business management platform that your entire organization can benefit from.
Other parts of the company will understand that they must also manage their documents or expand them for decision support or supplier management. So, you grow from using CANEA ONE as an eQMS for one part of the organization to a business management system that can support the whole company.
Uncomplicated and cost-effective integration
The CANEA ONE modules are easy to maintain. You don’t have to worry about coding and you can do the changes and configurations yourself. In addition, you can add new functionalities, users, or licenses as your needs evolve – this means you have complete control of your business management system! It is as simple as activating a license key. As a result, CANEA ONE is a future-proof and flexible solution.
The modules are also cost-efficient as you save on configuration, management and consultants since you can change or update the system yourself once it is installed. And you will have a modern, up-to-date system. Considering that the solution's average life span is up to seven years, that is quite a saving!
Tapping into the customer experience
One of CANEA ONE's customers is a global life science biotech company, Repligen. The company's activities are divided into four main areas, i.e., Proteins, Filtration, Chromatography, and Analytics.
"From my own perspective as a quality manager, it is a great advantage that I now easily can get an overview over company workflows. Today it is much easier to extract summaries and statistics from the system. It can be tricky to get a holistic overview with manual systems and lists in Excel. With CANEA ONE, however, it is much easier to sort information, and as a result, find new connections that you had not thought about before, basically just by "playing around" with numbers.
The system also helps us during inspections by ISO certification bodies as well as customers. It is just positive from all perspectives. We can quickly and easily access all requested information and present it as needed."
Anna Åkesson, Quality Manager at Repligen
Do you also want to have a modern eQMS and a more holisitic overview of your business? Learn more about how CANEA ONE's solutions can optimize your business management