For life sciences organizations, CFR Part 11 is a regulatory requirement for validating authenticity, integrity, and confidentiality of electronic records and electronic signatures. A compliance checklist for 21 CFR Part 11 thus plays a significant role in enabling an organization to become and stay compliant with FDA regulations, mitigate risk, and meet required standards around electronic documentation. Continue reading “CFR Part 11 Compliance Checklist: Ensuring Adherence to FDA Regulations”