1

Your cart is empty.



Celebrating 23 YEARS of Regulatory Excellence!
Go with the Most-Trusted Regulations & Guidelines Books on the Market.


Now Taking Orders for Our April 1, 2005 Books!        ALSO Check Out our Books with the ICH E6(R3) GUIDELINE FOR GOOD CLINICAL PRACTICE       See our BOOKSTORE Drop-Down Menu for included titles

Book 23:  2025 Part 11 & Drug Development:  Regulation, Preamble & FDA Guidance on Electronic Records & Electronic Signatures

Book 23: 2025 Part 11 & Drug Development: Regulation, Preamble & FDA Guidance on Electronic Records & Electronic Signatures

$ 17.95

Return to Previous Page

This spiral-bound, 5" x 7.5" book includes 21 CFR Part 11, its preamble, and several FDA Guidance Documents on electronic records, electronic signatures, and computerized systems in drug development. 

How is this Book Used?


• As a training aid for new and existing staff
• As an on-the-job reference source
• As a preparatory aid for an FDA inspection

What's the Price?
• 1-249 copies:  $17.95             • 250-499 copies:  $16.95
• 500-749 copies: $15.95          • 750+ copies:  $14.95

Custom Cover Prices*?
• 1-24 copies:  unavailable             • 25-100 copies:  $2.00/book
• 100-249 copies: $1.00/book        • 250+ copies:  No charge

* Based on quantities of a single book title

CFR Title 21:  Food and Drugs  (As of April 1, 2025)
       Part 11 - Electronic Records/Electronic Signatures
       
Preamble to 21 CFR Part 11 (62 FR 13429, March 20, 1997)

• FDA Guidance for Industry:  Electronic Records; Signatures -
   Scope & Application

• FDA Guidance for IRBs, Investigators, and Sponsors:  Use of Electronic Informed Consent: Questions and Answers

• FDA Guidance for Industry:  Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations:  Question and Answers

• Guidance for Industry: Electronic Source Data in Clinical Investigations

Click here to see an enlarged pdf cover