Castor EDC 2025.x.x 21 CFR Part 11 Statement of Compliance
Castor EDC has been designed and developed to comply with 21 CFR Part 11.
Castor achieves compliance through a combination of risk assessment, SOP adherence, and establishing a structured, validated system.
It is, however, the System User’s responsibility to ensure that the software, as provided, is deployed and used in a manner that is compliant with 21 CFR Part 11.
Castor_EDC_21_CFR_Part_11_Assessment_of_Compliance.pdf