Good Computer Validation Practices: Common Sense Implementation

Branning, Ronald C.,Stokes, Teri,Trill, Anthony J.,Chapman, Kenneth G.,Hambloch, Heinrich

ISBN 10: 0935184554 / ISBN 13: 9780935184556

Published by Interpharm Press, 1994

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Bibliographic Details

• Title: Good Computer Validation Practices: Common Sense Implementation
• Publisher: Interpharm Press
• Publication Date: 1994
• Language: English
• ISBN 10: 0935184554
• ISBN 13: 9780935184556
• Binding: hardcover
• Condition: Very Good

About this title

Synopsis

This sensible text on computer systems validation examines 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 needs of the healthcare manufacturing and research industries.