Computer Systems Validation
Quality Assurance, Risk Management, and Regulatory Compliance for Pharmaceutical and Healthcare Companies
1st Edition
Published on 18. December 2003
Book
Hardback
1032 pages
978-0-8493-1871-9 (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 assured, and validated. The most comprehensive guide on computer validation currently available, containing more than 200 illustrations and more than 100 tables, Computer Systems Validation helps you see the big picture.
The author reviews regulations and their development, organization responsibilities, validation life cycle based on GAMP4 Guide, strategic approaches to validation, electronic records and signatures, handling regulatory inspections, metrics, and opportunities for performance improvement. He presents practical examples and checklists throughout the book and explores the role of quality assurance and risk management as key components of pragmatic regulatory compliance. Covering methods that help you avoid duplicating effort among departments and business functions, the book demonstrates how you can use your investment in technology to improve business efficiency and gain the competitive edge.
The author reviews regulations and their development, organization responsibilities, validation life cycle based on GAMP4 Guide, strategic approaches to validation, electronic records and signatures, handling regulatory inspections, metrics, and opportunities for performance improvement. He presents practical examples and checklists throughout the book and explores the role of quality assurance and risk management as key components of pragmatic regulatory compliance. Covering methods that help you avoid duplicating effort among departments and business functions, the book demonstrates how you can use your investment in technology to improve business efficiency and gain the competitive edge.
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
Language
English
Place of publication
Bosa Roca
United States
Publishing group
Taylor & Francis Inc
Target group
College/higher education
Professional and scholarly
Professional
Illustrations
214 s/w Abbildungen, 138 s/w Tabellen
138 Tables, black and white; 214 Illustrations, black and white
Dimensions
Height: 254 mm
Width: 178 mm
Weight
2070 gr
ISBN-13
978-0-8493-1871-9 (9780849318719)
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
E-Book
12/2003
CRC Press
€456.99
Available for download
Guy Wingate
Computer Systems Validation
Quality Assurance, Risk Management, and Regulatory Compliance for Pharmaceutical and Healthcare Companies
E-Book
12/2003
1st Edition
CRC Press
€456.99
Available for download
Person
Guy Wingate
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.