This document applies to Castor eConsent version 2024.x.x as internally developed and tested. 

Castor eConsent has been designed and developed to be in compliance with 21 CFR Part 11, electronics records, electronic signatures, and predicate rules when implemented and controlled effectively by the System User. 

Castor achieves compliance through a combination of risk assessment, SOP adherence, and by establishing a structured validated system

eConsent_2024.x_21_CFR_Part_11_Assessment_of_Compliance.pdf