CSV: validation of computerized systems in the Life Sciences industry
The growing use of digital technologies in pharmaceutical industries, in particular, makesCSV(Computer System Validation), which controls the automated production of drugs, necessary. This validation provides the documented proof that a software application or a computer system will operate continuously and will therefore meet predefinedGxP(Good Practice)guidelines.
The ALTENCSV skills centrelocated inBelgiumis authorized to validate the computer systems of its Life Sciences customers. It consists of engineers that have dualbiochemistry + ITskills that are used, in particular, in the following sectors:
- dematerialized validation protocols
- software for controlling production or measurements
The ALTEN skills centre implements anumber of training systemsin order to remain state-of-the-art in this highly normative and regulated environment.
Within the framework of thelaboratory migration projectfora major pharmaceutical group, ALTEN, for example, successfully mobilized a team of10 engineers in Germany and Belgiumin order to integrate and validate48 itemsof critical equipment in the group’s IT network.