This document applies to Castor eConsent version 2024.x.x, which has been internally developed and tested.
Castor eConsent has been designed and developed to comply with 21 CFR Part 11, electronic records, electronic signatures, and predicate rules when implemented and controlled effectively by the System User.
Castor achieves compliance through a combination of risk assessment and SOP adherence, as well as by establishing a structured, validated system.