Systems Validation for Pharmaceutical Industry
from C.H.I.P.S.

Computer Systems Validation
Quality Assurance, Risk Management, and Regulatory Compliance for Pharmaceutical and Healthcare Companies

edited by Guy Wingate
Glaxo Smith Kline


  • 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

Computer Systems Validation is the most comprehensive guide on computer validation currently available, containing more than 200 illustrations and more than 100 tables.

Computer Systems Validation 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.

Computer Systems Validation 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.


Introduction - Why Validate?

  • Strategic Advantage
  • Problems Implementing Computer Systems
  • Good Practice
  • Costs and Benefits
  • Good Business Sense
  • Persistent Regulatory Non-Compliance
  • Wider Applicability

History of Computer Validation

  • A Regulatory Perspective
  • Developing Industry Guidance
  • Pivotal Inspection Incidents

Organization and Management

  • Organizational Responsibilities
  • Compliance Strategy
  • Validation Policy
  • Validation Procedures
  • Computer Systems Inventory
  • Validation Management
  • Management Review
  • Resource Planning
  • Key Principles for Computer System Validation

Supporting Processes

  • Training
  • Document Management
  • Change Control
  • Configuration Management
  • Self-Inspections
  • Managing Deviations
  • Example Self-Inspection Checklist

Prospective Validation Project Delivery

  • Character of Application
  • Approach to Validation
  • Choosing an Appropriate Life Cycle Methodology
  • Project Initiation & Validation Determination
  • Requirements Capture & Supplier (Vendor) Selection
  • Design & Development
  • Coding, Configuration & Build
  • Development Testing
  • User Qualification & Authorization to Use
  • Project Delivery Supporting Processes
  • Validation Package

Project Initiation and Validation Determination

  • Project Scope
  • Validation Determination
  • Validation Master Plan
  • Validation Plan
  • Validation Strategy

Requirements Capture and Supplier (Vendor) Selection

  • User Requirements Specification
  • GxP Assessments
  • Supplier Selection
  • Supplier Audits

Design and Development

  • Supplier Project and Quality Plans
  • Functional Specification
  • Requirements Traceability
  • Architectural Design
  • Software & Hardware Design
  • Design Review (inc. Hazard Study)
  • Accelerated Development

Coding, Configuration, and Build

  • Software Programming
  • Source Code Review
  • System Assembly

Development Testing

  • Testing Strategy
  • Unit & Integration Testing
  • System Testing
  • Pre-Delivery Inspection

User Qualification and Authorization to Use

  • Qualification
  • Pre-Qualification
  • Installation Qualification
  • Operational Qualification
  • Performance Qualification
  • Authorization to Use

Operation and Maintenance

  • Performance Monitoring
  • Repair & Preventative Maintenance
  • Upgrades, Bug-Fixes, and Patches
  • Data Maintenance
  • Backup and Retrieval
  • Archive and Restoration
  • Business Continuity Planning
  • Security
  • Contracts and Service Level Agreements (SLAs)
  • User Procedures
  • Periodic Review
  • Revalidation

Phase-Out and Withdrawal

  • Site Closures, Divestments & Acquisitions
  • Retirement
  • Replacement
  • Decommissioning

Validation Strategies

  • Organizational Roles & Responsibilities
  • Outsourcing
  • Standardizing Computer Applications
  • Segregating Integrated Systems
  • Retrospective Validation
  • Statistical Techniques

Electronic Records and Electronic Signatures

  • Electronic Records
  • Electronic Signatures
  • Operating Controls
  • Expected Good Practice
  • Implications for New Systems
  • Implications for Existing Systems

Regulatory Inspections

  • Inspection Authority
  • Inspection Practice
  • Inspection Process
  • Ensuring a State of Inspection Readiness
  • Providing Electronic Information During an Inspection
  • Inspection Analysis

Capabilities and Performance

  • Validation Capability
  • Project Validation Metrics
  • Operation & Maintenance Maxims
  • Process Improvement

Concluding Remarks

  • The Business Case for Validation
  • Industry Consensus
  • Golden Rules Remain Unchanged
  • Risk Management
  • Key Role of Suppliers
  • Organizational Change
  • The Final Analysis

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


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Computer Systems Validation
Quality Assurance, Risk Management, and Regulatory Compliance for Pharmaceutical and Healthcare Companies
edited by Guy Wingate, Glaxo Smith Kline

1,032 pages $548.95 + shipping
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