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 was something that emerged successively over a period of time, partly through our own experiences and partly through feedback from our ISO certification body. They saw a potential for improvement and that it would make it easier for us with a digitized solution instead of manual labor, says Anna Åkesson, Quality Manager at Repligen Sweden.
Repligen Sweden AB is a fully owned subsidiary of the global life science and biotech company Repligen. The company’s activities are divided into four main areas, i.e., Proteins, Filtration, Cromatography, and Analytics.
Repligen Sweden's production and laboratory facilities are located in Lund, in the southern part of the country, and is primarily dedicated to the production of proteins for the pharmaceutical industry. The proteins are produced from bacteria cultivated using microbial fermentation, and are, among other things, later used in the manufacturing of modern cancer drugs.
"Since our products are critical raw materials for our customers, we have chosen to base our ISO9001/14001 certified quality system on European GMP, a regulatory framework for pharmaceuticals. At Repligen, we do not manufacture pharmaceuticals directly but adheres to these standards in order to meet the requirements of our customers that do," says Anna Åkesson.
High requirements within the industry
Previously we had no management system. Instead, we were working manually with our documentation and cases. As the business expanded, the need for a management system became apparent, says Anna Åkesson.
CANEA ONE was one of the systems that Repligen evaluated in 2016.
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, says Anna Åkesson and continues:
We use CANEA Document and CANEA Workflow for case management. 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. Repligen Sweden was the first within the Repligen Group to implement CANEA ONE. The parent company who at the time already had a different system, has now partially switched over to using CANEA ONE for case management instead.
"Most people got started quickly with CANEA ONE thanks to its user-friendliness."
Positive response among employees
The overall response to the new system within the organization has been positive, although it is as always, a process to learn a completely new system. Most people get started quickly with CANEA ONE thanks to its user-friendliness. Instead of depending on a few people administrating a paper system centrally, we have now spread that responsibility out across the organization. As a result, the organization spends much less time on administrative activities than before, which of course is very positive, says Anna Åkesson.
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, says Anna Åkesson and adds: 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.
Repligen now sees that there are more workflows that could be digitized eventually, such as customer and supplier complaints.
"It's at the top of the list", concludes Anna Åkesson.