Examining the regulatory and practical issues of computer validation from a global perspective, this text provides a common-sense approach to getting the job done. Combining the insights of an internationally respected group of computer systems specialists, healthcare industry professionals, and a regulator, it provides SOPs, checklists, and tips to make global computer validation an obtainable goal. Topics and concerns covered in the text span the breadth of issues and influences imposed upon computer validation by worldwide GCP, GLP, and GMP requirements and provide an approach that meets the regulatory and real-world needs of the healthcare manufacturing and research industries.
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Inside This Book
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First Sentence:
There have been a number of high profile, costly, and embarrassing computer project disasters around the world in recent years. Read the first page Key Phrases - Capitalized Phrases (CAPs): (learn more)
Pharmaceutical Technology, United States, Standard Operating Procedure, Validation Project Plan, Computerized Drug Processing, Department of Health, Manufacture of Drug Products, Support System, Validation Master Plan, Blue Book, Commission of the European Communities, Compliance Policy Guide, European Community, New York, Computer Systems Validation Committee, Environmental Protection Agency, Good Clinical Practice, Signature Date, Fischers Lane, Freedom of Information Staff, Good Automated Laboratory Practices, Management Summary, National Computing Centre, Retrospective Testing of Computer Systems Valid, Definitions List New!
Books on Related Topics | Concordance | Text Stats Browse Sample Pages:
Front Cover | Table of Contents | First Pages | Index | Back Cover | Surprise Me!
There have been a number of high profile, costly, and embarrassing computer project disasters around the world in recent years. Read the first page Key Phrases - Capitalized Phrases (CAPs): (learn more)
Pharmaceutical Technology, United States, Standard Operating Procedure, Validation Project Plan, Computerized Drug Processing, Department of Health, Manufacture of Drug Products, Support System, Validation Master Plan, Blue Book, Commission of the European Communities, Compliance Policy Guide, European Community, New York, Computer Systems Validation Committee, Environmental Protection Agency, Good Clinical Practice, Signature Date, Fischers Lane, Freedom of Information Staff, Good Automated Laboratory Practices, Management Summary, National Computing Centre, Retrospective Testing of Computer Systems Valid, Definitions List New!
Books on Related Topics | Concordance | Text Stats Browse Sample Pages:
Front Cover | Table of Contents | First Pages | Index | Back Cover | Surprise Me!
Citations (learn more)
This book cites 11
books:
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22
books
cite this book:
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- Current Good Manufacturing Practice for Finished Pharmaceuticals (39th ed) by United States Food on page 198
- Out of Control by Rh Value Publishing on page 10
- Project Management (Harvard Business Review Paperback Series) by Harvard Business Review on page 73
- Health and Safety (Statutory Instruments) by The Stationery Office in Back Matter
- Drug Information by May on page 112
See all 11 books this book cites
- Validating Automated Manufacturing and Laboratory Applications: Putting Principles into Practice by Guy Wingate in Back Matter
- Validation and Qualification in Analytical Laboratories by Ludwig Huber on page 291
- Computer Validation Compliance: A Quality Assurance Perspective by Mary Ellen Double in Back Matter
- Validation for Medical Device and Diagnostic Manufacturers, Second Edition by Carol V. Desain in Back Matter
- The Survive and Thrive Guide to Computer Validation by Teri Stokes on page 71
See all 22 books citing this book
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