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Computer systems validation quality assurance risk management and regulatory compliance for pharmaceutical and healthcare companies 1st Edition by Guy Wingate ISBN 978-0203494240 0203494240

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Computer systems validation quality assurance risk management and regulatory compliance for pharmaceutical and healthcare companies 1st Edition Guy Wingate Digital Instant Download

Author(s): Guy Wingate
ISBN(s): 9780849318719, 0849318718
Edition: 1
File Details: PDF, 16.47 MB
Year: 2003
Language: english
SKU: EB-1185444 Category: Tag:

Computer systems validation quality assurance risk management and regulatory compliance for pharmaceutical and healthcare companies 1st Edition by Guy Wingate  – Ebook PDF Instant Download/Delivery: 978-0203494240, 0203494240
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Product details: 

ISBN 10:  0203494240

ISBN 13: 978-0203494240

Author: Guy Wingate

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

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 & AUTHORIZATION 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

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Tags: Guy Wingate, Computer systems, quality assurance, management and regulatory