1st Edition
Validating Pharmaceutical Systems Good Computer Practice in Life Science Manufacturing
Edited By John Andrews
Copyright 2006
572 Pages
by
CRC Press
572 Pages
by
CRC Press
576 Pages
by
CRC Press
Also available as eBook on:
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 on how to fulfill them. John Andrews and his team... Read more
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.
Eastern Europe (CEE). Distribution Management Validation in Practice.
Biography
John Andrews
