About this document

FDA Guidance on Electronic Records & Signatures by Sandeep Kumar is a document available to read on EtoBox.

This document provides guidance on the scope and application of FDA regulations regarding electronic records and electronic signatures. It clarifies that FDA will take a narrow view of which records are subject to these regulations and will exercise enforcement discretion for certain requirements, like validation and auditing, while the regulations are under re-examination. The guidance is intended to describe FDA

Author

Sandeep Kumar

Language

EN