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.