Validating Pharmaceutical Systems
Good Computer Practice in Life Science Manufacturing
Published on 3. August 2005
576 pages
978-1-135-48798-0 (ISBN)
Description
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
More details
Language
English
Place of publication
London
United Kingdom
Publishing group
Taylor & Francis Ltd
Target group
Professional and scholarly
Pharmaceutical company chief information officers; pharmaceutical company compliance managers and Q&A personnel; Pharmaceutical company FDA regulatory affairs personnel
Product notice
Reflowable
Illustrations
62 s/w Abbildungen, 51 s/w Tabellen
62 b/w images and 51 tables
File size
6,58 MB
ISBN-13
978-1-135-48798-0 (9781135487980)
Copyright in bibliographic data and cover images is held by Nielsen Book Services Limited or by the publishers or by their respective licensors: all rights reserved.
Schweitzer Classification
Other editions
Additional editions
Book
10/2019
1st Edition
CRC Press
€98.00
Shipment within 15-20 days
Book
08/2005
1st Edition
CRC Press
€247.83
Shipment within 15-20 days
Content
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.
