GAMP Good Practice Guide: GxP Compliant Laboratory Computerized Systems (Second Edition)

GAMP Good Practice Guide: GxP Compliant Laboratory Computerized Systems (Second Edition) cover image

Title:

GAMP Good Practice Guide: GxP Compliant Laboratory Computerized Systems (Second Edition)

Author(s):

Adler, Rachel; Brandstetter, Peter; Dube, David M.; Evans, Karen; Johnson, Craig R.; Lee, Carol; Luong, Kiet T.; McDowall, Bob; Newton, Mark; Samardelis, Judith S.; Smith, Paul; Vuolo-Schuessler, Lorrie; Ward, Peter

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Author(s): Adler, Rachel; Brandstetter, Peter; Dube, David M.; Evans, Karen; Johnson, Craig R.; Lee, Carol; Luong, Kiet T.; McDowall, Bob; Newton, Mark; Samardelis, Judith S.; Smith, Paul; Vuolo-Schuessler, Lorrie; Ward, Peter

Recently updated to conform with GAMP® 5 concepts and terminology, as well as recent regulatory and industry developments, the ISPE GAMP® Good Practice Guide: A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems (Second Edition) contains steps that scientists, suppliers and others involved in managing laboratory computerized system acquisition, implementation, and operations can use to verify laboratory systems are fit for their intended use. The Guide provides a practical, risk-based approach for evaluating these systems, thus eliminating trial and error. By following the principles outlined in the Guide, companies can save time and money, improve communication with external parties and achieve higher quality, better performing systems.

Table of Contents

GAMP Good Practice Guide: GxP Compliant Laboratory Computerized Systems (Second Edition)

Full Title: ISPE GAMP Good Practice Guide: A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems (Second Edition)
Pages: 160
Published: 2012-10-12