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Documentation Basics, second edition
That Support Good Manufacturing Practices and Quality System Regulations
by Carol DeSain
Tamarack Associates, LLC - 2001
Documentation Basics, second edition, includes everything you need to know about establishing a company-wide documentation system that meets GMP and QSR requirements.
Documentation Basics, second edition, continues to provide - like the first edition - a minimum set of standards to consider when designing document identification numbering systems or writing standard operating procedures, specifications, quality manuals, logbooks, etc.
Newly added features to the 2nd Edition are basic documentation practices for specific functional areas of operations such as Maintenance, Material Handling, Validation, Quality Control, Quality Assurance, and Production.
In medical manufacturing environments, a sound, sensible and simple documentation system is the foundation of GMP. Using sample documents and simple, step-by-step instructions, this book outlines the major components of a documentation system, demonstrates how they interact and provides examples of their design, format and content.
This comprehensive, hands-on guide will enable you to design an effective documentation system that ensures quality standards are met, minimizes errors, reduces downtime and serves as a training tool for line workers and administrators.
Available in Japanese at http://www.yakuji.co.jp/yakuji/tosyoindex.html
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Table of Contents
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SECTION 1 - IDENTIFIERS
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Chapter 1: Identification Numbers
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Chapter 2: Control Numbers
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Chapter 3: Status Numbers
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SECTION 2 - DOCUMENTS
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Chapter 4: Specifications
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Chapter 5: Standard Operating Procedures
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Chapter 6: Logbooks
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Chapter 7: Quality Manuals
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SECTION 3 - FUNCTIONAL AREA DOCUMENTATION BASICS
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Chapter 8: Material Handling Documentation Basics
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Chapter 9: Maintenance Documentation Basics
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Chapter 10: Quality Control Documentation Basics
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Chapter 11: Quality Assurance Documentation Basics
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Chapter 12: Production Documentation Basics
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Chapter 13: Validation Documentation Basics
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Soft cover book - $75.00:
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Electronic copy -
$105.00 -
(PDF 615KB):
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Chapters:
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1- | Identification Numbers
, | | | 2- | Control Numbers
, | | | 3- | Status Numbers
- FREE - (PDF 75.1KB):
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4- | Specifications
- $10.00 - (PDF 50.6KB):
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5- | Standard Operating Procedures
- $15.00 - (PDF 96.1KB):
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6- | Logbooks
- FREE - (PDF 14.1KB):
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7- | Quality Manuals
- FREE - (PDF 96.3KB):
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8- | Material Handling Documentation Basics
- $10.00 - (PDF 51.2KB):
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9- | Maintenance Documentation Basics
- $10.00 - (PDF 39.3KB):
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10- | Quality Control Documentation Basics
- $10.00 - (PDF 17.2KB):
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11- | Quality Assurance Documentation Basics
- $10.00 - (PDF 23.3KB):
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12- | Production Documentation Basics
- $20.00 - (PDF 157KB):
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13- | Validation Documentation Basics
- $20.00 - (PDF 191KB):
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