Quality built on courage
When you are up against tight deadlines it takes courage to stick to your own line of thinking. This proved to be a key success factor during the validation of Uppsala Imanet's new production line for the manufacture of radioactive tracers.
Uppsala Imanet AB built a new production line at the start of 2008 for the manufacture of radioactive tracers. Tracers are used for localizing and measuring biochemical and physiological processes in the body with the help of a, so called, PET camera (Positron Emission Tomography).
Validera was brought in to take on responsibility for the quality assurance and validation of the new production. "I am very satisfied with Validera's contribution. We kept to the time plan despite the fact that it was extremely tight," says Harald Schneider.
Harald Schneider appreciates the combination of exactness and ability to deliver which Validera's consultants have. "At times, we have had many long discussions. It was not always that I wanted to go the way Validera was proposing. But in the end I appreciate the fact that they had the courage to stick to their own line of thinking."
"As Project Leader you want to move forward quickly. Validera has the strength to stop, reflect on the situation and motivate actions needed to ensure quality."
Harald Schneider, Project Leader, Imanet
Validera's contribution has been reviewed by personnel responsible for quality at both Imanet and at corporate level within GE Healthcare. Everyone is satisfied. "Validera has done a very good job. I don't feel the slightest bit nervous about the Medical Products Agency's inspection. We are well prepared," says Alexandra Constantinescu, Imanet's Quality Manager.
"Validera has done a very good job. I don't feel the slightest bit nervous about the Medical Products Agency's inspection."
She explains that Validera's consultants got up to speed extremely quickly and that they worked at a pertinent level of ambition. "They are very professional and competent!"
Uppsala Imanet AB carries out clinical diagnostics together with Uppsala University Hospital and performs clinical trials where PET-technology is used. Within this framework, Imanet develops and manufactures radioactive trace molecules which are used to localize tumors and measure various processes in the body. The latter with a focus on what happens in the brain with different dementia illnesses and how different medicines work and integrate. Over 40 people work at Uppsala Imanet AB, a part of GE Healthcare, which operates in more than 100 countries and has annual revenue of USD 15 billion.