Managing the top 5 demands of your Quality Assurance program – Improving business operations: Spotlight on Repligen

Repligen, a prominent bioprocessing-focused life sciences company based in the United States, operates globally and includes Repligen Sweden AB, its fully-owned subsidiary. The company specializes in developing and commercializing high-value products and flexible solutions that play a crucial role in the production of biologic drugs. Repligen’s offerings are categorized into four key areas: Proteins, Filtration, Chromatography, and Analytics.

The company’s rapid business expansion necessitated a reevaluation of their document management processes. “Previously, we lacked a formal management system. We relied on manual handling of our documentation and cases. As our business grew, the need for an organized management system became evident,” explains Anna Akesson, Quality Manager at Repligen Sweden. This need for a new system arose gradually, driven by their own experiences and feedback received during ISO certification processes.

Recognizing the immense potential for improvement and seeking to streamline their operations, Repligen opted for a digital solution to replace manual labor. This transition aimed to enhance efficiency and simplify processes within the company.

The choice fell on CANEA ONE because of the user-friendliness of the system and that it was easy to adapt to our specific needs ”

Anna Akesson, Quality Manager at Repligen

Among the solutions under consideration, Repligen chose CANEA ONE and adopted two specific modules: Document and Workflow. The Document module enables seamless management of documents throughout their life cycle. This comprehensive approach encompasses all stages, including production, publication, revisions, and ultimately, archiving and deletion.

With the Workflow module, Repligen has the capability to automate and optimize processes. This automation ensures accurate handovers occur, reaching the appropriate individuals efficiently and effectively. This strategic move simplifies operations, making tasks more manageable for the company.

In the Workflow module, we started by digitizing three workflows and then added one more. Today it includes change management, deviations, CAPA (Corrective And Preventive Action) and incident management. 

Anna Akesson, Quality Manager at Repligen

Automated processes, better document control and overall audit capability

“As a Quality Manager, having the ability to effortlessly gain insights into our company’s workflows is incredibly advantageous. CANEA ONE has simplified the process significantly. Extracting summaries and statistics from the system is now a seamless task. In contrast, dealing with manual systems and Excel lists can be complex when trying to obtain a comprehensive overview. With CANEA ONE, sorting information becomes effortless, allowing for the discovery of unexpected connections. Essentially, just by ‘playing around’ with the data, new insights emerge. CANEA ONE provides immediate access to reports and metrics, putting valuable information right at your fingertips.

Moreover, this solution proves invaluable during inspections conducted by ISO certification bodies and customers. The ease with which we can access and present the necessary information is remarkable. Overall, the experience with CANEA ONE has been nothing but positive from every perspective,” affirms Anna Akesson.

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.