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21 CFR Component 11:

This steerage is supposed to describe the food and Drug administration’s (FDA’s) contemporary questioning concerning the scope and alertness of element 11 of identify 21 of the Code of Federal rules; digital facts; electronic Signatures (21 CFR element eleven).2

This document presents guidance to individuals who, in fulfillment of a requirement in a statute or any other a part of FDA’s regulations to keep statistics or post data to FDA3, have selected to keep the information or submit certain information electronically and, as a result, have become difficulty to component eleven.


In March of 1997, FDA issued very last component 11 rules that offer standards for recognition by using FDA, beneath sure occasions, of digital information, digital signatures, and handwritten signatures executed to electronic information as equivalent to paper facts and handwritten signatures achieved on paper.

After component eleven have become effective in August 1997, full-size discussions ensued among industry, contractors, and the enterprise concerning the translation and implementation of the guidelines. FDA has (1) spoken approximately component eleven at many conferences.

Met several times with an industry coalition and other fascinated events so that it will hear extra approximately capacity element eleven issues; (2) posted a compliance policy manual, CPG 7153.17: Enforcement coverage: 21 CFR part 11; digital facts; Digital Signatures; and (three) posted several draft steering files


The Usual Approach To Component 11 Necessities

Part 11 might be interpreted narrowly; we’re now clarifying that fewer records could be considered concern to element 11.
For the ones information that remain challenge to component 11, we intend to exercising enforcement discretion with reference to part eleven requirements for validation, audit trails, document retention.

File copying within the manner defined on this steering and with regard to all element 11 requirements for systems that have been operational earlier than the effective date of element 11 (also referred to as legacy systems).
We are able to put in force all predicate rule requirements, consisting of predicate rule file and recordkeeping necessities.

Information Of Method – Scope Of Part 11

Slim Interpretation Of Scope

We understand that there’s a few confusion about the scope of element 11. Some have understood the scope of component eleven to be very wide. We agree with that some of the ones wide interpretations could lead to pointless controls .

Charges and will discourage innovation and technological advances without imparting delivered benefit to the public health. As a result, we want to clarify that the corporation intends to interpret the scope of component 11 narrowly.