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

ISBN-13: 9780849318719 / Angielski / Twarda / 2003 / 1032 str.

Guy Wingate; Wingate Wingate; Guy Wingate

Opis

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 latest regulatory developments for the US FDA and other regulatory authorities. 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. It reviews over twenty case studies from renowned industry experts who examine different types of computer systems.

Recenzje

"…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)

Spis treści

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 & 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 & VALIDATION DETERMINATION
Project Scope
Validation Determination
Validation Master Plan
Validation Plan
Validation Strategy

REQUIREMENTS CAPTURE & SUPPLIER (VENDOR) SELECTION
User Requirements Specification
GxP Assessments
Supplier Selection
Supplier Audits

DESIGN & 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 & AUTHORISATION TO USE
Qualification
Pre-Qualification
Installation Qualification
Operational Qualification
Performance Qualification
Authorization to Use

OPERATION & 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 & 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 & 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 & 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

O autorze

Guy Wingate