High requirements in the biotech industry led Repligen to choose CANEA ONE

The nature of the biotech industry put high requirements on what a quality management system needs to deliver. For the biotech company, Repligen, CANEA ONE was the system that met their specific needs.

The need for a new system became apparent gradually, influenced by both our experiences and input from our ISO certification body. They identified room for enhancement and suggested that a digitized solution would be more convenient than manual processes, explains Anna Åkesson, Quality Manager at Repligen Sweden.

Repligen Sweden AB is a wholly-owned subsidiary of the global life science and biotech company Repligen. The company’s operations are organized into four main segments: Proteins, Filtration, Chromatography, and Analytics.

Repligen Sweden’s production and laboratory facilities are situated in Lund, a southern region of the country. Their primary focus is on producing proteins for the pharmaceutical industry. These proteins are derived from bacteria cultivated using microbial fermentation, and they play a significant role in the creation of modern cancer medications.

Given that their products are crucial components for their customers, Repligen Sweden has chosen to establish their ISO 9001/14001 certified quality system based on European GMP, a regulatory framework for pharmaceuticals.

Anna Åkesson notes, “At Repligen, we don’t directly manufacture pharmaceuticals, but we adopt these standards to meet the needs of our customers who do.”

High requirements within the industry

In the past, we operated without a management system. Our approach involved manual handling of documentation and cases. As our business expanded, the necessity for a management system became evident, according to Anna Åkesson.

During the evaluation phase in 2016, CANEA ONE was among the systems considered by Repligen.

“The decision to go with CANEA ONE was driven by the system’s ease of use and its adaptability to our specific requirements,” says Anna Åkesson. She continues, “We utilize CANEA Document and CANEA Workflow for case management. Initially, we digitized three workflows within the Workflow module and later added another. This now includes managing changes, deviations, CAPA (Corrective And Preventive Action), and incidents.”

Repligen Sweden took the lead in adopting CANEA ONE within the Repligen Group. Although the parent company had a different system in place, they have transitioned to using CANEA ONE partially for case management.

“CANEA ONE’s user-friendliness enabled most individuals to quickly get started,” Anna Åkesson highlights.

Positive response among employees

The general reaction to the new system within the organization has been favorable, although, as expected, there’s a learning curve when adapting to an entirely new system. Most individuals quickly grasp how to use CANEA ONE due to its user-friendly design. Instead of relying on a small group of people to centrally manage a paper-based system, this responsibility has been distributed across the organization. This shift has significantly reduced the time spent on administrative tasks, which is undeniably beneficial, according to Anna Åkesson.

“As a quality manager, I find it highly advantageous that I can now easily gain an overview of company workflows. Extracting summaries and statistics from the system has become much simpler. Unlike manual systems and Excel lists, which can make getting a comprehensive view challenging, CANEA ONE streamlines information sorting. This has led to uncovering new connections by simply experimenting with data,” mentions Anna Åkesson. She further adds, “The system also proves invaluable during inspections by ISO certification bodies and customers. It’s an all-around positive tool. We can promptly access all requested information and present it as necessary.”

Repligen now envisions digitizing more workflows in the future, such as addressing customer and supplier complaints.

Anna Åkesson concludes, “That’s a top priority on our agenda.”

Get a quick overview so you can spend your time improving your processes.

You can easily define and set up processes according to your own needs using a convenient layout tool. In addition, since all types of workflow processes can be managed, you get all case management in one single system. 

Analyses, statistics and reports give you an unbeatable overview with real-time status and division of responsibility. Nothing has to fall through the cracks anymore and you always have an accurate and up-to-date base for decision-making.

CANEA Process is a tool that allows you to model and share business processes in an easy-to-use graphical web interface.

Seeing is understanding

Visualisation gives all employees an understanding of the organisation’s processes, activities, responsibilities and information flows.

Living processes

Identifying working methods while making it easy to update is the basis for continuous improvement of processes.

Create a complete picture

Linking together documents, information and tools with clickable process maps create an intuitive and comprehensive management system.

CANEA Workflow is an IT solution that automates, quality-assures and speeds up administrative workflow processes.

You can easily define and set up processes according to your own needs using a convenient layout tool. In addition, since all types of workflow processes can be managed, you get all case management in one single system. 

Analyses, statistics and reports give you an unbeatable overview with real-time status and division of responsibility. Nothing has to fall through the cracks anymore and you always have an accurate and up-to-date base for decision-making.

By creating executable processes in CANEA Workflow, you get both better control of the situation and smoother processing.

Streamlining the work

Ensure compliance and that handovers are done correctly and with the right information.

Correct decision support

You get an unbeatable overview of the processes in real time, with both clear reports and clear diagrams.

Improve processes continuously

Our process support can be constantly adapted to changing needs and requirements. In this way, we give you the best possible conditions for your daily work.

A document management system without complicated folder structures.

CANEA Document combines simple and intuitive search features with powerful features for managing documents from a life cycle perspective.

Maximum availability
Search and find information quickly based on what you need, not where it is stored.

High security
Ensure accuracy, changes and access to all information – with high traceability.

Fulfils requirements
Manage information according to standards, legislation and other requirements for document management.

CANEA Document supports everything from production, publication and modification to archiving and deletion – with full traceability and version management.

CANEA Document provides secure management of all types of documents – in one place. Tagging the information with metadata creates a virtual, multidimensional folder structure. This means that a document appears in multiple locations at the same time, with authorisation-controlled access. The right information in the right place for the right users at the right time!

You can usefully add your company’s process-oriented management system to CANEA Document. All production and distribution of documents is quality-assured and streamlined. In addition, your employees always have access to the most up-to-date version of the documents – directly via intranet, tablets and mobile phones.

Improve the performance of your project activities

CANEA Project is a comprehensive project tool with integrated support for all types of projects and parties– such as management, resource owners, clients, project managers and project participants. CANEA Project gives you an excellent overview of your entire project portfolio, including profitability and status, making it easier to prioritize and make decisions.

CANEA Project shares all important project information with both internal and external members.

Let your project manager focus on management rather than administration and distribution of the information.

Gather all project information in one place and make it available to both internal and external members.

Helps you with prioritization of projects, resource management and analysis of portfolios and programs.

Make reality of the strategy

CANEA Strategy makes it possible for organisations of all sizes to create a unique common thread from the strategic work to the daily operations. We do not just provide performance management tools but rather a completely new generation of IT support for strategy activation. The system guarantees and provides support throughout the chain from strategy to execution. You get no results without action. CANEA Strategy makes it possible in practise! 

CANEA Strategy ensures and provides support throughout the entire journey from strategy to execution.

Create a shared understanding of the strategy, the goal to achieve and how.

Gives management an unbeatable overview of what’s happening, how it’s progressing, and why.

Creates a clear common thread from the strategy to project, initiatives and actions.