FDA 21 CFR Part 11 Compliance and Checklist

Compliance with U.S. Food and Drug Administration (FDA) 21 CFR Part 11 is essential for regulated companies using electronic records and signatures.

With 21 CFR Part 11, the FDA ushered in the use of modernized technology for records and submissions. By affirming that electronic records and signatures are equally as legitimate as paper records and handwritten signatures, Part 11 has given companies the opportunity to automate and streamline manufacturing and quality processes. 

A 21 CFR Part 11 compliance checklist can guide you through the maze of regulatory requirements and help your organization meet the appropriate compliance standards.

21 CFR Part 11 Compliance Checklist