
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• FDA DRAFT Guidance for Industry: Electronic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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