[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR11.50]

[Page 123]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 11--ELECTRONIC RECORDS; ELECTRONIC SIGNATURES--Table of Contents
 
                      Subpart B--Electronic Records
 
Sec. 11.50  Signature manifestations.

    (a) Signed electronic records shall contain information associated 
with the signing that clearly indicates all of the following:
    (1) The printed name of the signer;
    (2) The date and time when the signature was executed; and
    (3) The meaning (such as review, approval, responsibility, or 
authorship) associated with the signature.
    (b) The items identified in paragraphs (a)(1), (a)(2), and (a)(3) of 
this section shall be subject to the same controls as for electronic 
records and shall be included as part of any human readable form of the 
electronic record (such as electronic display or printout).