Computer Systems Validation:
Quality Assurance, Risk Management, and Regulatory Compliance for
Pharmaceutical and Health Care Companies
Guy Wingate
Hardcover: 1,030+ pages
Size: 10" x 7.5" x 2.5"
ISBN 0849318718
CRC Press
December 2003 (click below for the very best currently available price for
this important resource)
Computer Systems Validation is the most comprehensive
guide to computer validation currently available.
This invaluable reference discusses good laboratory, clinical,
manufacturing, and distribution practices and explains the critical
regulatory developments for the US FDA and other regulatory
authorities. The role of risk management throughout the life
cycle of a computer system is emphasized not only for the benefit of
patient/consumer safety but also in terms of cost-effectiveness.
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.
"…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)
Practical examples and checklists appear throughout the
book, together with an exploration of the role of quality assurance
and risk management as key components of pragmatic regulatory
compliance.
Contains 24 case studies
illustrating the practicalities of validating different types of
computer systems supporting laboratories
Discusses GCPs, GLPs,
GMPs, GDPs, and Medical Device regulations from around the
world, with explanations of the latest regulatory developments
from the US FDA
Supplies comprehensive
coverage of computer validation principles and how to put them
into practice
Contains more than 200
illustrations
Includes more than 100 tables
Presents practical examples and
checklists throughout
This resource also reviews over
twenty case studies from renowned industry experts who examine
different types of computer systems.
Table of Contents:
Chapter 1
Why Validate?
1
Chapter 2
History of Computer
Validation
19
Chapter 3
Organization and
Management
45
Chapter 4
Supporting Processes
69
Chapter 5
Prospective Validation
Project Delivery
93
Chapter 6
Project Initiation and
Validation Determination
123
Chapter 7
Requirements Capture and
Supplier (Vendor) Selection
149
Chapter 8
Design and Development
179
Chapter 9
Coding, Configuration,
and Build
215
Chapter 10
Development Testing
233
Chapter 11
User Qualification and
Authorization to Use
249
Chapter 12
Operation and Maintenance
283
Chapter 13
Phaseout and Withdrawal
317
Chapter 14
Validation Strategies
331
Chapter 15
Electronic Records and
Electronic Signatures
357
Chapter 16
Regulatory Inspections
383
Chapter 17
Capabilities, Measures,
and Performance
415
Chapter 18
Concluding Remarks
441
Chapter 19
Case Study 1:
Computerized Analytical Laboratory Studies
449
Chapter 20
Case Study 2:
Chromatography Data Systems
465
Chapter 21
Case Study 3: Laboratory
Information Management Systems (LIMS)
511
Chapter 22
Case Study 4: Clinical
Systems
541
Chapter 23
Case Study 5: Control
Instrumentation
557
Chapter 24
Case Study 6:
Programmable Logic Controllers
587
Chapter 25
Case Study 7: Industrial
Personal Computers
603
Chapter 26
Case Study 8: Supervisory
Control and Data Acquisition Systems
619
Chapter 27
Case Study 9: Distributed
Control Systems
643
Chapter 28
Case Study 10: Electronic
Batch Recording Systems (Manufacturing Execution
Systems)
657
Chapter 29
Case Study 11: Integrated
Applications
669
Chapter 30
Case Study 12: Building
Management Systems
679
Chapter 31
Case Study 13:
Engineering Management Systems
695
Chapter 32
Case Study 14:
Spreadsheets
729
Chapter 33
Case Study 15: Databases
749
Chapter 34
Case Study 16: Electronic
Document Management Systems (EDMS)
765
Chapter 35
Case Study 17: MRP II
Systems
779
Chapter 36
Case Study 18: Marketing
and Supply Applications
801
Chapter 37
Case Study 19: IT
Infrastructure and Associated Services
841
Chapter 38
Case Study 20: Local and
Wide Area Networks
875
Chapter 39
Case Study 21: Web
Applications
897
Chapter 40
Case Study 22: Medical
Devices and Their Automated Manufacture
909
Chapter 41
Case Study 23: Blood
Establishment Computer Systems
