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CFR Rule Changes by GXPNews

21 CFR Part 11
Part 11 with Scope and Application
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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Price $3.20 $3.10 $3.00 $2.90 $2.70 $2.10 $1.50
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Parts 11 with Scope and Application and Preambles
Part 11 with Scope and Application (Aug. 2003), now comes with the additional Preambles!
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Price $6.90 $6.50 $5.90
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Parts 11 and 210/211
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Price $5.95 $5.85 $5.75 $5.45 $4.95 $4.35 $3.25
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Parts 11, 210/211 & 820
Parts 11, 210/211 & 820 - The GMP Predicate Rules
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Part 58 GLP & Part 11 ERES
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Price $5.95 $5.85 $5.75 $5.45 $3.25 $4.95 $4.35
11 & Computerized Systems used in Clinical Investigations
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11 & 110 - Electronic Records with Food GMPs
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5 Book Minimum
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PDMA - Parts 11, 203 & 205
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Price $5.95 $5.40
5 Book Minimum
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Parts 11 and 820
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Price $5.95 $5.85 $5.75 $5.45 $4.95 $4.35 $3.25
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Part 11 Checklist
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Parts 11 and 111
$6.95 Quantity   
11, 58 and 820
$6.90
Electronic Records, GLP Part 58 and QSR Part 820
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Basic EU GMPs Chapter 1 - 9
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5 Book Minimum! Basic EU GMPs Chapter 1 through 9 with Glossary
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