Audit Trail

Any change made gets registered, indicating: who did it, when and the value previous and after the change. This allows to reliably audit the entire data in the current system

ShareCRF registers any change in the eCRF variables, keeping the information of who did it, when and the previous and after values of the variables involved in the change. This allows for a continuous and reliable audit of each change that is made in each and every one of the data entered in the system.

ShareCRF meets the technical requirements of control to meet the requirements FDA 21 CFR Part 11 and ICH GCP in the audit of electronic data collection