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21 CFR Part 11
Part 11 with Scope and Application
1-933734-00-0
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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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PDMA - Parts 11, 203 & 205
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Part 11 and 820
1-933734-06-X
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11 & The GMP Part11 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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Electronic Systems Master Handbook 1
978-1-935131-15-1
Electronic Systems Master Handbook 1 – Parts 11, Scope and Application, EU Annex 11, EU Annex 15, Electronic Systems Check List, Computerized Systems used in Clinical Investigations.
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Clinical Master Reference Guide
978-1-935131-27-4
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GMP Auditor’s Basic Handbook
978-1-935131-29-8
- Part 11 - Part 210/211 - Part 820 - Part 11 Checklist - GMP Checklist - 820 Checklist
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GMP - PAT Handbook
978-1-935131-31-1
Complete GMP with PAT Guidance, Parts 11,, 210/211, 820 and Guidances - Part 11 Scope and Application, ICH Q7, GMP Auditor's Check List, Pat Guidance, Drug Manufacturing Inspection 7356.002 and Quality Systems Approach to Pharmaceutical CGMP Regulations.
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