Xellia Pharmaceuticals is a world-leading manufacturer of Active Pharmaceutical Ingredients (APIs). As a medical company, Xellia is subject to many governmental requirements, for example the US requirements from the FDA (Food and Drug Administration).
Compliance with these requirements demands the use of IT systems that support the documenting of the company’s procedures and work processes. At the same time, it is important that processes for developing and maintaining staff skills in association with the quality assurance system can be managed.
”Symfoni QMS provides us with an overview and ensures that the latest version of a document is used”, says Business Application Project Manager, Britta Bach, from Xellia Pharmaceuticals in Denmark
Xellia has been subjected to multiple FDA inspections following the implementation of Symfoni QMS. They have never received any comments from the FDA as the system and its implementation satisfy FDA requirements.
Symfoni improves cooperation across the company
For the company’s management and staff that work across departments, the greatest benefit has been that symfoni QMS simplifies the location of the appropriate documents.
”We have achieved far better control over updates, versions and document approvals”, explains Business Application Project Manager, Britta Bach.
Excellent cooperation with Symfoni
Throughout the process Xellia experienced an extremely satisfying level of cooperation with Symfoni. According to Xellia, ”Symfoni has shown great understanding of our needs and problems, while at the same time they implemented the entire system according to our wishes. We appreciate and place high value on the fact that we can work with the same people time after time. This has simplified communication and allowed for more effective cooperation.”