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21 CFR Part 11

FDA Food and Drug Administration
FDA Code of Federal Regulations Mini-Handbooks!
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CFR Rule Changes by GXPNews
Part 11 with Scope and Application
1-933734-00-0
21 CFR Part 11 Pocket Guide — Electronic Records; Electronic Signatures
This regulation pertains to electronic records, electronic signatures and handwritten signatures executed to electronic records. This part also applies to records in electronic form that are created, modified, maintained, archived, retrieved or transmitted, under any records requirements set forth in agency regulations.


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Part 11 with Scope and Application and Preambles
1-933734-51-5
Part 11 with Scope and Application (Aug. 2003), now comes with the additional Preambles!
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Part 11 and 210/211
1-933734-03-5
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Part 11, 210/211 & 820
1-933734-52-3
Parts 11, 210/211 & 820 - The GMP Predicate Rules
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Part 58 GLP & Part 11 ERES
1-933734-01-9
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Part 11 & Computerized Systems used in Clinical Investigations
1-933734-07-8
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Part 11 & 110 - Electronic Records with Food GMPs
1-933734-02-7
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5 Book Minimum

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PDMA - Parts 11, 203 & 205
1-933734-04-3
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Part 11 and 820
1-933734-06-X
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Part 11 Checklist
1-933734-08-6
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Part 11 and 111
978-1-935131-48-9
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Part 11, 58 and 820
978-1-935131-45-8
Electronic Records, GLP Part 58 and QSR Part 820
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Medical Device Quality Systems Manual with 11, 210/211 & 820
978-1-935131-07-6
Medical Device Quality System Manual with 11, 210/211 & 820 QSR
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