Based near Oslo in Norway, Fresenius Kabi removed their paper-based processes, instead implementing an electronic quality management solution to meet the requirements laid down by authorities and practices such as ISO, cGMP and FDA. Also, with 25% of their work being awarded by contract manufacturers, their new system was required to improve on those paper processes to continue to meet increasing demands of their customers and contractors.
Ideagen’s Q-Pulse, an electronic compliance management solution, was implemented to help with internal non-conformance management and make it easier to maintain compliance with their governing standards and practices. The solution has since helped the company ease workload and save money by reducing the use of paper.
Q-Pulse has helped Fresenius Kabi’s FK Halden base to maintain and demonstrate compliance with a number of standards, including ISO 9001, ISO 13485, ISO 14001 and GMP-certification with FDA-approval.
Benefits
- Compliance with ISO, cGMP, and FDA requirements are easily met with electronic quality management system Q-Pulse
- Visibility of entire quality management system with minimum clicks
- Management can quickly identify any potential issues and where they could occur
- Identify any overdue actions and who is responsible for these actions
- Easily stand up to regulatory or customer audits, displaying relevant compliance ‘on demand’
- Quality Co-ordinator has saved 1 hour per day using Q-Pulse compared to the previous paper-based system
Q-Pulse is built on a robust and stable base, which still forces processes to be followed. This means that system bypasses and shortcuts are not possible, improving the overall quality and safety in the long run – which is a major positive for the system.
Erik Paulsen, Quality Coordinator, Fresenius Kabi