The need for effective and sustainable validation has long been in demand within Life Science. As the authorities make great demands, it is extra important that the routines are correct and that these are followed and are well documented. Validation ensures that a production process is consistent in achieving the predetermined specifications and properties set. An important parameter for both producer and end customer.
Knightec's employee Jenny Tjernberg is a sought-after expert in Computerized System Validation (CSV). She highlights the benefits of validation in Life Science.
– For my own part, it is inspiring and varied, as we are currently in a process of change. Life Science has the potential to take inspiration from other industries that are at the forefront of digitalization. Now we are in a paradigm shift and a lot is happening and there is a lot of talk about efficiency and safety, says Jenny.
Safety is one of Jenny's most important issues. As a CSV expert, her main task is to ensure that test results are linked to a computer and software, and that nothing - under any circumstances - is modified. Something that takes time and resources.
– I would like to say that everything is risk-based and scalable, which suits me well. It is a pragmatic work process that can be difficult to understand, but which means that you have an investigative role that is constantly changing, says Jenny.