Guidance for Industry FDA 21 CFR Part 11, Electronic Records; Electronic Signatures — Scope and Application

This guidance is intended to describe the Food and Drug Administration's (FDA’s) current thinking regarding the scope and application of part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures (21 CFR Part 11).

In March of 1997, FDA issued final part 11 regulations that provide criteria for acceptance by FDA, under certain circumstances, of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures executed on paper. These regulations, which apply to all FDA program areas, were intended to permit the widest possible use of electronic technology, compatible with FDA's responsibility to protect the public health.

This document provides guidance to persons who, in fulfillment of a requirement in a statute or another part of FDA's regulations to maintain records or submit information to FDA, have chosen to maintain the records or submit designated information electronically and, as a result, have become subject to part 11. Part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in Agency regulations. Part 11 also applies to electronic records submitted to the Agency under the Federal Food, Drug, and Cosmetic Act (the Act) and the Public Health Service Act (the PHS Act), even if such records are not specifically identified in Agency regulations (§ 11.1). The underlying requirements set forth in the Act, PHS Act, and FDA regulations (other than part 11) are referred to in this guidance document as predicate rules.

I. INTRODUCTION

II. BACKGROUND

III. DISCUSSION

A. Overall Approach to Part 11 Requirements

B. Details of Approach – Scope of Part 11

C. Approach to Specific Part 11 Requirements