Computer Systems Validation
Quality Assurance, Risk Management, and Regulatory Compliance for Pharmaceutical and Healthcare Companies
1st Edition
Published on 18. December 2003
1032 pages
978-1-135-49631-9 (ISBN)
Description
Both pervasive and ubiquitous, computerized systems are now an integral component of every corporate strategy in pharmaceutical and healthcare companies. However, when technology is combined with high-risk public safety projects or the production and control of life-saving medicines or devices, it is necessary to ensure that it is reliable, quality
Reviews / Votes
"...Whether you are looking for the missing piece of the jigsaw puzzle for your project or guidance on how to meet the regulations in a practical sense, this information resource (which puts principles into practice) is a good place to start!"- from the foreword by Anthony Trill, Medicines and Healthcare Products Regulatory Agency (MHRA)
More details
Edition
1. Auflage
Language
English
Place of publication
London
United Kingdom
Publishing group
Taylor & Francis Ltd
Target group
Professional and scholarly
Control engineers, laboratory technicians, IT professionals, pharmaceutical and healthcare management, engineering contracting companies, computer system and software suppliers, analytical equipment suppliers, and consultants
Product notice
Reflowable
Illustrations
214 s/w Abbildungen, 138 s/w Tabellen
214 b/w images and 138 tables
ISBN-13
978-1-135-49631-9 (9781135496319)
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
Guy Wingate
Computer Systems Validation
Quality Assurance, Risk Management, and Regulatory Compliance for Pharmaceutical and Healthcare Companies
Book
12/2003
1st Edition
CRC Press
€402.34
Shipment within 15-20 days
Content
Introduction - Why Validate? History of Computer Validation. Organization & Management. Supporting Processes. Prospective Validation Project Delivery. Project Initiation & Validation Determination. Requirements Capture & Supplier (Vendor) Selection. Design & Development. Coding, Configuration, and Build. Development Testing. User Qualification & Authorization to Use. Operation & Maintenance. Phase-Out & Withdrawal. Validation Strategies. Electronic Records & Electronic Signatures. Regulatory Inspections. Capabilities & Performance. Concluding Remarks. CASE STUDIES: Analytical Laboratory Instruments. Chromatography Data Systems (CDS). Laboratory Information Systems (LIMS). Clinical Systems. Control Instrumentation. Programmable Logic Controllers (PLCs). Industrial Personal Computers. Supervisory Control and Data Acquisition (SCADA) Systems. Distributed Control Systems (DCS). Electronic Batch Record Systems (Manufacturing Execution Systems). Integrated Automation Systems. Building Management Systems (BMS). Engineering Management Systems. Spreadsheets. Databases. Electronic Document Management Systems (EDMS). Manufacturing Resource Planning (MRP II) Systems. Marketing & Supply Systems. IT Infrastructure & Associated Services. Networks. Web Applications. Medical Devices. Blood Processing. Process Analytical Technology.
