Features
- Cover Type: Hard Cover with 324 pages
- Published by: Interpharm Press May 31, 1994
- Written in: English
- ISBN 10 Number: 0935184554
- ISBN 13 Number: 978-0935184556
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Book Dimensions:
9.2 x 6 x 1 inches
- Weighs: 1.5 pounds
Product Description
This sensible text on computer systems validation looks at the regulatory and practical issues of computer validation from a global perspective and 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 detailed 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 requirements of the healthcare manufacturing and research industries.