HistoGeneX chooses Quality by Design for quality assurance15/12/2015 - Yves Dène, Lead Consultant CSV at Quality by Design
QbD supports HistoGeneX’ strong growth by optimizing computer systems
HistoGeneX summons the assistance of Quality by Design, the expert in quality assurance for enterprises in the pharmaceutical, bio technical and cosmetics industry. Because of the rapid and considerable growth of HistoGeneX – specialized in the development of predictive bio markers for cancer treatments – the organization started the search for a partner for the constant validation of its computer systems. HistoGeneX chose to work with QbD because of its track record the company built with other companies in the industry. The collaboration enables HistoGeneX to guarantee the security of patient records, and to prove the integrity of its data during an audit or governmental inspection.
Since 2001, HistoGeneX has been conducting cancer research, an industry with a lot of international legislation when it comes to data integrity. Processes need to designed in such a way that the safety of the patient is never at risk. Therefore it is essential that the computer systems used meet all the set requirements. That is the reason HistoGeneX started a search for a party to offer support for audits and governmental inspections. QbD helps to optimize the use of computer systems and to demonstrate the safety of doing so.
Mark Kockx, CEO of HistoGeneX: “We invest a lot in our computer systems, and thanks to QbD we know exactly where the focus should be when it comes to IT validations. It is truly team work. This is great to see during an audit, whenever there are any remarks, they are dealt with together. The two teams have really deserved each other’s trust.”
Yves Dène, CSV Lead at Quality by Design: “As a pharmaceutical company, it is necessary to continuously meet the requirements set by the government. And those requirements are always changing, just like the technology that is used. Take the privacy legislation for example: where do you install your servers, in Europe or elsewhere or on-premises? We follow these developments closely, and deploy our knowledge and expertise for HistoGeneX. From the start, we felt very welcome there, and already receive a lot of appreciation for our work. I look forward to our continued collaboration.”
HistoGeneX is currently developing a high speed predictive markers for cancer immune therapy.
Depicted in the image is an example of a cellular analysis of the immune cells in a tumor biopt. (CD3-FoxP3 double coloured)