Some of the files below are in
format and require Acrobat Reader.
Guidance for Industry Part 11, Electronic Records; Electronic Signatures — Scope and Application
CFR Part 11. Electronic Records; Electronic Signatures; Final Rule
Electronic Submissions; Establishment of Public Docket; Notice.
Recently Posted FDA Warning
Current FDA (CDER) guidance documents.
A-Z Index of FDA website
and Guidance: Implementation of the Government Paperwork Elimination Act
specifically states that electronic records and their related electronic
signatures are not to be denied legal effect, validity, or enforceability
merely because they are in electronic form, and encourages Federal
government use of a range of electronic signature alternatives.
Guidance for industry regarding general principles for
Information on FDA Current Good Manufacturing Practice in Manufacturing, Processing, Packing,
or Holding of Drugs.
Current Good Manufacturing Practice for Medical Devices
Computer Security Resource Center (CSRC) is designed
to collect and disseminate computer security information and resources to
help users, systems administrators, managers, and security professionals
better protect their data and systems. A primary goal of the CSRC is to
raise awareness of all computer systems users -- from novice to expert --
about computer security. This is perhaps the most important way of
improving information systems security.