21 CFR Part 11 Compliance Checklist

Review This 21 CFR Part 11 Compliance Checklist to See If Your Company Meets Regulations

The regulations outlined in 21 CFR Part 11 set the ground rules for automated record keeping systems for organizations subject to FDA oversight. 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 Industry Overview: Ready for an FDA Inspection?