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, 2023)
       Part 11 - Electronic Records/Electronic Signatures
       
• Preamble to 21 CFR Part 11 (62 FR 13429, March 20, 1997)

• FDA DRAFT Guidance for Industry: Electronic
   Source Data in Clinical Investigations

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

• FDA Guidance for Industry:  Providing Regulatory
   Submissions in Electronic Format - General Considerations

• FDA Guidance for Industry:  Computerized Systems Used in
   Clinical Investigations

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