Computer Systems Validation: Quality Assurance, Risk Management, and Regulatory Compliance for Pharmaceutical and Healthcare Companies, 1st Edition (Hardback) book cover

Computer Systems Validation

Quality Assurance, Risk Management, and Regulatory Compliance for Pharmaceutical and Healthcare Companies, 1st Edition

Edited by Guy Wingate

CRC Press

1,032 pages | 214 B/W Illus.

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Hardback: 9780849318719
pub: 2003-12-18
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pub: 2003-12-18
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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.

Reviews

"…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)

Table of Contents

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

Subject Categories

BISAC Subject Codes/Headings:
MED071000
MEDICAL / Pharmacology