1.0 INTRODUCTION

Ensuring compliance with FDA regulations is a critical responsibility for organizations that handle electronic records and E-signatures. This document serves as a comprehensive guide for individuals and entities required by statute or FDA regulations to maintain records or submit information to the FDA. Specifically, it addresses the criteria outlined in 21 CFR Part 11, which stipulates that electronic records and electronic signatures must be trustworthy, reliable, and equivalent to paper records. By following the guidance provided herein, stakeholders can ensure that their electronic systems meet these stringent standards, thereby facilitating compliance and enhancing the integrity of their data management processes.

2.0 PURPOSE

21 CFR Part 11 is the part of criteria under which the electronic records and electronic signature are considered trustworthy, reliable, and equivalent to the paper record.

3.0 SCOPE

The Scope of this 21 CFR Part 11 Requirement Assessment document is only applicable for control System for “(Software/SCADA/System Name)” Which is located in ‘‘Location Name” at “XYZ Company Name"

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