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This book is written for the industry that develops, manufactures, and markets medical products for human and veterinary use. This industry is regulated by the FDA. The documents and the document management systems presented in this text, however, can be applied to any regulated industry, such as the EPA, USDA, or OSHA, or to any industry that develops or manufactures products for human use.
- Sales Rank: #1711087 in Books
- Brand: Brand: ADVANSTAR COMMUNICATIONS
- Published on: 1996
- Ingredients: Example Ingredients
- Dimensions: 9.30" h x .50" w x 6.30" l,
- Binding: Hardcover
- 180 pages
- Used Book in Good Condition
From the Inside Flap
Documentation Practices: A complete guide to document development and management for GMP and ISO 9000 compliant industries includes everything you ever needed, or wanted, to know about documents and document management systems. It provides an accurate and meaningful understanding of manual document management requirements; features complete coverage of documents, documentation, document management, and document systems; and includes specific examples of Commitment Documents, Directive Documents, and Data Collection Documents.
The information Documentation Practices provides will help the inexperienced reader understand the purpose of documents and documentation; will aide the experienced reader in designing new electronic documents, databases, and management systems; and will provide both with valuable insights when existing systems begin to fail.
From the Back Cover
Documentation Practices demystifies the documentation process and provides an accurate and meaningful understanding of manual document management requirements. It includes comprehensive information about documents, documentation, document management, and document systems, and it features specific examples of Commitment Documents, Directive Documents, and Data Collection Documents. The knowledge this book provides will minimize the number of documents required to achieve compliance and will help in designing electronic documents, databases, and management systems in the future.
About the Author
Carol DeSain is an independent consultant with 22 years' experience in product development, manufacturing, and quality control, and specific expertise in the design and implementation of QA documentation systems.
Charmaine Vercimak Sutton is an independent consultant to medical product manufacturers, providing services in product development, clinical design and management, quality system development and implementation and regulatory compliance to meet FDA expectations.
Together, DeSain and Sutton provide GMP regulatory consulting for drug, device, and biologics manufacturers through their Tofte, Minnesota-based company, The Tamarack Group.
Most helpful customer reviews
0 of 0 people found the following review helpful.
Good practical reference book
By Hawkins
This is a very good reference book and a good addition to my library. There were some good ideas on practical approaches to implementing document sysyems.
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