[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
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.
Back to Top
© 2007 Betterchem Corp.
|
