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GMP Publications, Inc.

Food & Drug Administration (FDA)
 U.S. FDA Code of Federal Regulations & EU ICH Handbooks
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All U.S. FDA CFR handbooks updated as of April 1st. 2010 - NOW SHIPPING!
CFR Rule Changes by GXPNews

Just Released July 8, 2010 Federal Register: FDA To Conduct Inspections Focusing on 21 CFR 11 (Part 11) requirements relating to human drugs 

Pick up your copy of the Part 11 Electronic Systems Master Handbook! - GXP Academy for On-Site Part 11 Training $6,995 (2 Day all Inclusive!) 866-GXPNews

GXP Electronic Systems Master Handbook - More
Don't forget - You can mix and match parts!  Call for a free quote today! 856-810-7331
Includes all of the Electronic Systems regulations in an easy to carry 3.75" x 6.25" handbook -
Starts at $11.90 each. - Updated April 1st. 2009

US FDA Title 21 CFR Parts and Guidance References
  -  Part 11 - Electronic Records
  -  Scope and Application 2003
  -  Computerized Systems Used In Clinical Investigations 2007


European Union (EU) Annexes
  -  Annex 11 - Computerized Systems
  -  Annex 15 - Qualification and Validation


Includes:  The Auditing Group Part 11 Check List for Computerized Systems

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