16 April 2020 - The EMA has published a notice about validating and qualifying all types of computerised systems used in clinical trials. 

EMA released the notice in response to “recent inspection findings” and their implications for the “integrity, reliability, robustness and acceptability of data.”

Computerised systems such as electronic case report forms and clinical trial management systems are now critical to the conduct of clinical trials and the collection of the data they generate, making the performance of the technology a key enabler of regulatory compliance.

Read Regulatory Affairs Professional Society article