Comprehensible, clear and easy-to-use risk management, even for a wide range of products
EUROIMMUN is one of the leading manufacturers of test systems, devices and software for human and veterinary laboratory diagnostics. More than 3,000 employees worldwide work together on the development, production and distribution of reagents and vending machines. EUROIMMUN products are used in over 150 countries to diagnose autoimmune and infectious diseases and allergies and to carry out genetic analyses. The company has extensive expertise in the fields of immunology, cell biology, histology, biochemistry and molecular biology.
Challenge: Finding a perfectly coordinated system
As a manufacturer of IVDs, Euroimmun has a very broad range of products and must maintain an individual risk management file for each one. This has led to many uncertainties among employees regarding the risk files, and methodological and formal inconsistencies have repeatedly arisen. “With over 200 employees involved in risk management in the company, a common understanding and a uniform approach is absolutely essential,” explains Dr. Jungmann in the interview.
In order to manage this work and meet the regulatory requirements (e.g. FDA – CFR 21 Part 11 compliance), Euroimmun started looking for software solutions in 2017 and discovered BAYOOSOFT Riskmanager.
Opting for the market leader
After attending a webinar and a free trial evaluation, EUROIMMUN decided in 2017 to use BAYOOSOFT Riskmanager to create its risk management files. The Essential Requirements, Requirements Engineering and Usability Engineering modules are also used to further support the technical documentation of in-vitro diagnostics. This means that all requirements and standards relevant to EUROIMMUN are covered in one system in a clear and time-saving manner. EUROIMMUN opted for the supplementary Prevalidation Package for complete software validation in accordance with ISO 13486.
Cost savings achieved
After a quick and smooth implementation of the software solution and the training of the employees, it was possible to start working on the documentation straight away. “The predefined input masks, which meet the requirements of the standards, make risk management activities much easier,” explains Ms. Gehring, Quality Management at Euroimmun. “The Risk Manager is also well received during audits and makes it easier to understand, especially thanks to the clearly laid out documents and graphic display with filter options.”
EUROIMMUN has made many improvements, particularly in usability engineering, which is closely linked to risk management in some areas. The template now provided by the Risk Manager makes it possible to maintain the usability file in compliance with the standard.
“Previously, we worked with Excel spreadsheets and things could easily get lost. Our alternative ALM software solutions were very generic and not much better than the Excel spreadsheets. With Riskmanager, we don’t have to worry about this, as maintained documentation is generated completely at the touch of a button. All in all, the solution allows us to focus on the content of the risk analyses and guides us through the process.” concludes Dr. Jungmann.
