Validating Pharmaceutical Systems (eBook, ePUB)

Good Computer Practice in Life Science Manufacturing
Redaktion: Andrews, John

• Format: ePub

Produktbeschreibung

All too often, the words "computer validation" strike terror into the hearts of those new to the process and may even cause those familiar with it to tremble. Validating Pharmaceutical Systems: Good Computer Practice in Life Science Manufacturing delineates GCP, GLP, and GMP regulatory requirements and provides guidance from seasoned practitioners

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Produktdetails

• Verlag: Taylor & Francis eBooks
• Seitenzahl: 576
• Erscheinungstermin: 3. August 2005
• Englisch
• ISBN-13: 9781135487980
• Artikelnr.: 73213928

Autorenporträt

John Andrews

Inhaltsangabe

Foreword. Editor's Introduction. Considerations for Computerized System
Validation in the 21st Century Life Sciences Sector. An Inspector's
Viewpoint. State of the Art Risk Assessment and Management. Validation
Planning and Reporting. Audit Preparation for Suppliers: A Question and
Answer Approach. Developing Good Specifications. Traceability of
Requirements Throughout the Lifecycle. Good Documentation in Practice. Good
Testing Practice: Part 1. Enterprise Resource Planning Services - Aligning
Business and Validation Requirements. Calibration in Practice. Validating
Legacy Systems. Technology Transfer Keys. Qualifying SCADA Systems in
Practice Acquisition. The Application of GAMP4 Guidelines to Computer
Systems Found in GLP Regulated. The Validation of a LIMS System - A Case
Study. Compliance and Validation in Central and Eastern Europe (CEE).
Distribution Management Validation in Practice.