The most comprehensive guide to computer validation currently available, this invaluable reference discusses good laboratory, clinical, manufacturing, and distribution practices and explains the latest regulatory developments for the US, European and other regulatory authorities. Practical examples and checklists appear throughout the book and the authors explores the role of quality assurance and risk management as key components of pragmatic regulatory compliance. He reviews over twenty case studies of different types of computer systems. Latest FDA and PIC/S developments concerning computer validation, electronic records and signatures, and process analytical technologies are included.
Computer Systems Validation
and over one million other books are available for Amazon Kindle.
Learn more
FREE Two-Day Shipping for students on millions of items. Learn more |
| |||||||||||||||
|
There is a newer edition of this item:
|
Book Description
Special Offers and Product Promotions
- Buy $50 in qualifying physical textbooks, get $5 in Amazon MP3 Credit. Here's how (restrictions apply)
Product Details
Would you like to update product info or give feedback on images?
|
Customer Reviews
|
There are no customer reviews yet.
|
|||
|
Video reviews
|
Inside This Book
(learn more)
First Sentence:
Computer systems support billions of dollars of pharmaceutical and healthcare sales revenues. Read the first page Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
divesting organization, key validation documents, single upper confidence limit, computer systems validation, hookup drawings, validation deliverables, regulatory observations, divested site, validating firm, engineering management strategy, validation life cycle, current regulatory expectations, analytical laboratory systems, change control records, predelivery inspection, chromatography data system, electronic signature requirements, validation summary report, configurable software packages, outsource organization, source code reviews, validation master plan, validate computer software, managing deviations, validating computer systems Key Phrases - Capitalized Phrases (CAPs): (learn more)
Warning Letter, Pharmaceutical Engineering, European Union, Code of Federal Regulations Title, Computerised Systems, Buffalo Grove, Interpharm Press, Six Sigma, Good Laboratory Practice, New York, Putting Principles, Available Available, Department of Health, Functional Design Specification, Pharmaceutical Technology, Good Practice Guide, Commercial Off-The-Shelf, Inspection Response Team, Good Clinical Practice, Outline Specification, Pharmaceutical Inspection Convention, General Principles of Software Validation, Information Technology, Guy Wingate, Pharmaceutical Inspection Co-operation Scheme New!
Books on Related Topics | Concordance | Text Stats Browse Sample Pages:
Front Cover | Table of Contents | First Pages | Index | Back Cover | Surprise Me!
Computer systems support billions of dollars of pharmaceutical and healthcare sales revenues. Read the first page Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
divesting organization, key validation documents, single upper confidence limit, computer systems validation, hookup drawings, validation deliverables, regulatory observations, divested site, validating firm, engineering management strategy, validation life cycle, current regulatory expectations, analytical laboratory systems, change control records, predelivery inspection, chromatography data system, electronic signature requirements, validation summary report, configurable software packages, outsource organization, source code reviews, validation master plan, validate computer software, managing deviations, validating computer systems Key Phrases - Capitalized Phrases (CAPs): (learn more)
Warning Letter, Pharmaceutical Engineering, European Union, Code of Federal Regulations Title, Computerised Systems, Buffalo Grove, Interpharm Press, Six Sigma, Good Laboratory Practice, New York, Putting Principles, Available Available, Department of Health, Functional Design Specification, Pharmaceutical Technology, Good Practice Guide, Commercial Off-The-Shelf, Inspection Response Team, Good Clinical Practice, Outline Specification, Pharmaceutical Inspection Convention, General Principles of Software Validation, Information Technology, Guy Wingate, Pharmaceutical Inspection Co-operation Scheme New!
Books on Related Topics | Concordance | Text Stats Browse Sample Pages:
Front Cover | Table of Contents | First Pages | Index | Back Cover | Surprise Me!
Books on Related Topics
(learn more)
|
Tags Customers Associate with This Product(What's this?)Click on a tag to find related items, discussions, and people.
|
Customer Discussions
|
This product's forum
Active discussions in related forums
Search Customer Discussions
|
Related forums
|
Listmania!
So You'd Like to...
Look for Similar Items by Category
- Books > Computers & Technology > Software
- Books > Medical Books > Administration & Medicine Economics > Health Care Delivery
- Books > Medical Books > Pharmacology > Pharmacy
- Books > New & Used Textbooks > Computer Science
- Books > New & Used Textbooks > Medicine & Health Sciences > Administration & Policy > Health Care Delivery
- Books > New & Used Textbooks > Medicine & Health Sciences > Medicine > Basic Sciences > Pharmacology
- Books > Professional & Technical > Engineering
- Books > Science & Math > Technology
