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.”