This webinar provides a short introduction into the “Guideline on computerised systems and electronic data in clinical trials”. It will show how the authorities want to ensure data integrity. The presentation will cover the three levels of the guideline from data flow diagrams to the different annexes. Not all details can be presented in the webinar, but it will highlight the new expectations of the EMA, some of which are helpful and some present challenges. There are no one-solution-fits-all answers, but some points and ideas to consider for your organization should emerge from the webinar.