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.
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Book Description
Editorial Reviews
About the Author
Carol DeSain is the author of Documentation Practices and Risk Management Basics. She lives in Tofte, Minnesota.
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Most Helpful Customer Reviews
2 of 2 people found the following review helpful:
5.0 out of 5 stars
A Must Have for any QA person,
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Amazon Verified Purchase(What's this?)
This review is from: Documentation Basics That Support Good Manufacturing Practices and Quality System Regulations (Paperback)
The book is excellent. I only wish I had it 3 years ago when I started in QA. It is a basics book. There isnt a lot of detail but it is a good frame work for starting a regulated or soon to be regulated company.
2 of 2 people found the following review helpful:
5.0 out of 5 stars
Whooeee! Some reading!,
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This review is from: Documentation Basics That Support Good Manufacturing Practices and Quality System Regulations (Paperback)
I'm in a Good Manufacturing Practices environment and my manager, the head of Manufacturing Quality Assurance, kept mentioning this book and referencing it in her Standard Operating Procedure documents. It's expensive, but it is a textbook and a reference book. This book has been the gold standard for 20 years or so. You'll want to read through it completely. Then, after that, it is good reading to keep in your car or work desk for those times when you have a few minutes to spare. Keep reviewing the information to stay fresh. This is a recent edition with update for Quality standards.Don't talk about it over pizza and beer with your friends on Friday night though. It probably won't help you get a date!!
3.0 out of 5 stars
Good content, expensive, no index,
By Frieda "Frieda" (Deep South, USA) - See all my reviews
This review is from: Documentation Basics That Support Good Manufacturing Practices and Quality System Regulations (Paperback)
This is a mixed review. The content is good. It could be organized a little more clearly. I was, and continue to be, very disappointed that there is no index. Especially at this price point, I would expect a technical reference book to be well indexed.Content is a good primer and reference for entry level people in the business as well as for students. The text covers a good amount of topics, but while the content that it does have is good, it is sparse on details. For example, "SOP Review and Approval" has a one paragraph description. Pros The content that is there is good Good coverage of topics Some sample documents Cons Price No index Content is sparse Organization is so-so
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Inside This Book
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Key Phrases - Statistically Improbable Phrases (SIPs):
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maintenance department, purchasing controls, move ticket, documentation practices, material identification numbers, quality system components, equipment identification numbers, document identification numbers, process validation studies, manufacturing events, manufacturing record, receiving code, installation qualification, batch record Key Phrases - Capitalized Phrases (CAPs): (learn more)
Tofte Medical, Quality Assurance, Material Handling, Document Control, Standard Practice Document, Date Exhibit, The Approval, Quality Manual, Quality System Manual, Production Documentation Basics, Quality Control, Product Management Practices, Maintenance Documentation Basics, Bill of Materials, Standard Operating Procedures, Product Development, Labeling Batch Record, Good Manufacturing Practices, Date Verified, Production Department, Consult Exhibit, Regulatory Control, Validation Documentation Basics, Puerto Rico, Label Reconciliation New!
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Front Cover | Table of Contents | First Pages | Back Cover | Surprise Me!
maintenance department, purchasing controls, move ticket, documentation practices, material identification numbers, quality system components, equipment identification numbers, document identification numbers, process validation studies, manufacturing events, manufacturing record, receiving code, installation qualification, batch record Key Phrases - Capitalized Phrases (CAPs): (learn more)
Tofte Medical, Quality Assurance, Material Handling, Document Control, Standard Practice Document, Date Exhibit, The Approval, Quality Manual, Quality System Manual, Production Documentation Basics, Quality Control, Product Management Practices, Maintenance Documentation Basics, Bill of Materials, Standard Operating Procedures, Product Development, Labeling Batch Record, Good Manufacturing Practices, Date Verified, Production Department, Consult Exhibit, Regulatory Control, Validation Documentation Basics, Puerto Rico, Label Reconciliation New!
Books on Related Topics | Concordance | Text Stats Browse Sample Pages:
Front Cover | Table of Contents | First Pages | Back Cover | Surprise Me!
Citations (learn more)
This book cites 2
books:
- Risk Management Basics by Charmaine Vercimak Sutton in Front Matter, and Back Matter
- A42.2 System Components Video by Cengage Learning Delmar on page 45, and page 48
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