[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR11.30]



[Page 112]

 

                        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.  11.30  Controls for open systems.



    Persons who use open systems to create, modify, maintain, or 

transmit electronic records shall employ procedures and controls 

designed to ensure the authenticity, integrity, and, as appropriate, the 

confidentiality of electronic records from the point of their creation 

to the point of their receipt. Such procedures and controls shall 

include those identified in Sec.  11.10, as appropriate, and additional 

measures such as document encryption and use of appropriate digital 

signature standards to ensure, as necessary under the circumstances, 

record authenticity, integrity, and confidentiality.