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Pharmaceutical Science Book from C.H.I.P.S.

Pharmaceutical Computer Systems Validation
Quality Assurance, Risk Management and Regulatory Compliance
Second Edition
edited by Guy Wingate

Pharmaceutical Computer Systems Validation examines computer validation and verification principles and how to put them into practice.

Topics:

  • GAMP5, ASTM 2500, EU GMP (Annex 11), and US GMP revisions
  • ICH Guidance Q8, Q9, and Q10 expectations
  • FDA cGMPs for the 21st Century Initiative and associated guidance
  • PIC/S Guidance on Good Practice for Computerized Systems in GxP Environments
  • WK9864 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
  • FDA/EU/Japan regulators/industry developments
  • QA and internal/external suppliers
  • integration of computer systems validation into single overall approach
  • common high, medium, and low risk issues
  • partners and legacy systems
Pharmaceutical Computer Systems Validation reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. All 24 case studies from the first edition have been revised.

Contents

1. Introduction

Strategic Advantage

  • Rudimentary Computer System Characteristics
  • Trends in Today’s Computing Environment
Problems Implementing Computer Systems
  • Industry Observations
  • Regulatory Observations
New 21st Century Paradigm
  • Key Principles & Terminology
  • Life Cycle Approach within QMS
  • Scaleable Life Cycle Activities
  • Process and Product Understanding
  • Science Based Quality Risk Management
  • Leveraging Supplier Involvement
Good Practice
  • Quality Assurance
  • GxP Philosophy
  • Duty of Care
  • Buyer Beware
Business Case
  • Benefits
  • Implementation Cost
  • Cost of Failure
  • Measuring Success
  • Misconceptions
Good Business Sense

Persistent Regulatory Non-Compliance

Wider Applicability

2. History of Computer Validation

A Regulatory Perspective

  • Significant Regulatory Developments
  • Good Manufacturing Practice (GMP)
  • Good Distribution Practice (GDP)
  • Good Laboratory Practice (GLP)
  • Good Clinical Practice (GCP)
  • Medical Devices
  • Electronic Records and Electronic Signatures (ERES)
  • Collective GxP Requirements
Developing Industry Guidance
  • PMA’s Concept Paper
  • Red Apple Consensus Report
  • GAMP Supplier Guide
  • PDA’s Technical Report on Computer Validation
  • PhRMA’s Computer Validation Key Practices
  • GAMP3
  • PDA/GAMP Harmonised Terminology
  • GAMP Infrastructure & PDA Network Guidance
  • PDA Technical Report on Laboratory Systems
  • GAMP4
  • PDA/ISPE Good Practice & Compliance for Part 11
  • GAMP Guide for Electronic Signatures & Records
  • PIC/S GxP Computerised System Guidance
  • GAMP5
  • Body of Knowledge
Pivotal Inspection Incidents

3. Organisation and Management

Organisational Responsibilities

  • Quality & Compliance Roles
  • Concept of Internal Supplier
  • External Supplier Responsibilities
  • Recent Inspection Findings
Compliance Strategy
  • Organisation Considerations
Policy and Procedures
  • Recent Inspection Findings
Computer Systems Inventory

Project Delivery

  • Getting Started
  • Life Cycle Approach
  • Risk Management
  • Recent Inspection Findings
Management Review
  • Recent Inspection Findings
Resource Planning

Key Principles for Computer System Compliance

4. Supporting Processes

Training

  • Organisational Roles
  • Qualifications
  • Training Plans & Records
  • Recent Inspection Findings
Document Management
  • Document Preparation
  • Document Review
  • Document Approval
  • Document Issue
  • Document Change
  • Document Withdrawal
  • Document Administration & Storage
  • Quality of Documentation
  • Recent Inspection Findings
Change Control
  • Request for Change
  • Change Evaluation (Impact Analysis) and Authorisation
  • Testing and Implementation of the Change
  • Change Completion and Approval
  • Emergency Changes
  • Recent Inspection Findings
Configuration Management
  • Configuration Identification
  • Configuration Control
  • Configuration Status Accounting
  • Configuration Evaluation
  • Recent Inspection Findings
Self-Inspections Managing Deviations 5. Approach to Project Delivery

Approach to Validation

  • Standard Software
  • Commercial Off-The-Shelf (COTS) Products
  • Open Source Software Software Tools
  • Managing User Modifications
  • Software Reuse
  • Managing Change
  • Roles & Responsibilities
Choosing an Appropriate Life Cycle Methodology
  • Integrating Systems
  • Segregating Systems
Project Initiation and Compliancne Determination
  • Project Scope (Outline Specification)
  • Compliance Determination
  • Validation (Master) Planning
  • Project & Quality Plans
Requirements Capture and Supplier (Vendor) Selection
  • User Requirements Specification (URS)
  • GxP Assessment
  • Request for, Receipt of, and Evaluation of Proposals
  • Supplier Selection
  • Purchase Orders and Contracts of Supply
Design and Development
  • Supplier Project & Quality Plan
  • System Overview
  • Functional Specification
  • Architectural Design
  • Hardware and Software Design
  • Data Definition (inc. Configuration)
  • Operating Manuals
  • Design Review (inc. Hazard Study)
Coding, Configuration and Build
  • Hardware Platform
  • Application Software
  • Source Code Review
Development Testing
  • Unit/Module Testing
  • System/Integration Testing
  • Pre-Delivery Inspection
User Qualification and Authorisation to Use
  • Pre-Qualification Activities (Commissioning & Calibration)
  • Data Load (inc. Configuration)
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Operation and Maintenance Pre-requisites
  • Validation (Summary) Reports
Project Delivery Supporting Processes
  • Training
  • Document Management
  • Change Management
  • Configuration Management
  • Requirements Traceability
  • Deviation Management
Validation Package
  • Reviews and Approvals
6. Project Initiation and Compliance Determination

Project Scope

  • Understanding the Scope of the Computer System
  • Outline Specification
  • Project Risk Management
  • Project & Quality Plans
  • Glossary of Terms
Validation Determination
  • Early Indication of Validation Requirement
  • Compliance Determination Statement
Validation Master Plan
  • Hierarchy of Validation Master Plans
  • Contents of Validation Master Plans
  • Structure of Validation Master Plans
  • Preparation of a Validation Master Plans
  • Recent Inspection Findings
Validation Plan
  • Contents of Validation Plan
  • Preparation of a Validation Plan
  • Supplier Relationships
  • Magnitude of Validation Effort
  • Recent Inspection Findings
Validation Strategy
  • Approach to Hardware
  • Approach to Software
  • Criticality-Impact Analysis
  • Managing Compliance Issues
7. Requirements Capture and Supplier (Vender) Selection

User Requirements Specification

  • Contents
  • Electronic Record/Signature Requirements
  • Recent Inspection Findings
GxP Assessments
  • Identifying GxP Processes and Functions
  • Identifying Critical Components and Devices
  • Recent Inspection Findings
Supplier Selection
  • Regulatory Expectations
  • Invitation To Tender
  • Supplier Proposal
  • Proposal Evaluation
  • Contract of Supply
  • Recent Inspection Findings
Supplier Audits
  • Applicability
  • Audit Preparations
  • Conducting Audits
  • Audit Report & Follow-Up
  • Preferred Suppliers
  • User Groups
  • Recent Inspection Findings
8. Design and Development

Supplier Project and Quality Plans

Functional Specification

  • Content
  • Dealing with COTS Products
  • Anticipating Testing
  • Recent Inspection Findings
Requirements Traceability
  • Maintenance
  • Recent Inspection Findings
Architectural Design
  • Recent Inspection Findings
Software and Hardware Design
  • Software Design
  • Hardware Design
  • Dealing with COTS Hardware and Software
  • Recent Inspection Findings Design Review (inc. Hazard Study)
    • HACCP
    • CHAZOP
    • FMEA
    • Dealing with COTS Hardware and Software
    • Recent Inspection Findings
    Accelerated Development
    • Prototyping
    • Rapid Application Development
    • Extreme Programming
    9. Coding, Configuration, and Build

    Software Programming

    • Programming Approach
    • Redundant Code (‘Dead Code’)
    • Compilers
    • Recent Inspection Findings
    Source Code Review
    • Review Criteria
    • Reporting
    • Effectiveness
    • Access to Application Code
    • Recent Inspection Findings
    System Assembly

    10. Developement Testing

    Testing Strategy

    • Test Plans
    • Test Specifications
    • Test Conditions
    • Test Traceability
    • Text Execution
    • Independent Checks
    • Test Outcome
    • Inconsequential Test Deviations
    • Test Failures
    • Issues Log
    • Test Reporting
    • Managing Changes During Testing
    • Test Environment
    • Inspection Findings
    Unit and Integration Testing
    • Structural (White-Box) Testing
    • Acceptance Testing of COTS Software and Hardware
    • Inspection Findings
    System Testing
    • Functional (Black-Box) Testing
    • Upgrade Compatibility
    • Inspection Findings
    Pre-Delivery Inspection

    11. User Qualification and Authorisation to Use

    Qualification

    • Test Documentation
    • Leverage Development Testing
    • Beta Testing
    • Stress Testing
    • Parallel Operation
    • Inspection Findings
    Pre-Qualification
    • Site Preparations
    • Calibration
    • Data Load
    • Inspection Findings
    Installation Qualification
    • Inventory Checks
    • Operating Environment Checks
    • Diagnostic Checks
    • Documentation
    • Inspection Findings
    Operational Qualification
    • Scope of Testing
    • Test Reduction
    • Verifying SOPs
    • Test Environment
    • System Release
    • Inspection Findings
    Performance Qualification
    • Product Performance Qualification
    • Process Performance Qualification
    • Inspection Findings
    Authorisation to Use
    • Validation Report
    • Validation Summary Report
    • Validation Certificate
    • Inspection Findings
    12. Operation and Management Maintenance

    Performance Monitoring

    • Monitoring Plan
    • tatus Notification
    • Recent Inspection Findings
    Repair and Preventative Maintenance
    • Scheduling
    • Calibration
    • Documentation
    • Recent Inspection Findings
    Upgrades, Bug-Fixes and Patches
    • Why Upgrade?
    • Bug-Fixes & Patches
    • Installation & Validation
    • Upgrade Considerations
    • Beta Software
    • Quick Fix
    • Availability of Software & Reference Documentation
    • Prioritising Changes
    • Recent Inspection Findings
    Data Mainenance
    • Data Life Cycle
    • Audit Trails
    • Retention of Raw Data
    • Recent Inspection Findings
    Backup and Retrieval
    • Scheduling
    • Media
    • Recent Inspection Findings
    Archive and Restoration
    • Archiving Requirements
    • Retrieving Archives
    • Storage Requirements
    • Recent Inspection Findings
    Business Continuity Planning
    • Procedures & Plans
    • Redundant Systems & Commercial Hot Sites
    • Service Bureau
    • Backup Agreements
    • Cold Sites
    • Manual Ways of Working
    • Software Licences
    • Recent Inspection Findings
    Security
    • Management
    • Computer Viruses
    • Recent Inspection Findings
    Contracts and Service Level Agreements (SLAs)
    • Recent Inspection Findings
    User Proceders
    • Recent Inspection Findings
    Periodic Review
    • Recent Inspection Findings
    Revalidation
    • Recent Inspection Findings
    13. Phase-Out and Withdrawl

    Site Closures, Divestments and Acquisitions

    • Site Closures
    • Site Divestments
    • Site Acquisitions
    Retirement
    • Electronic Records Management
    • Preservation of Archive Records
    • Duration of Retention
    • Archiving Options
    Replacement
    • Migration Strategy
    • Legacy Systems
    Decommissioning

    14. Electronic Record and Electronic Signatures

    Electronic Records

    • Record Life Cycle
    • Audit Trail
    • Timestamps
    • Meta-Data
    • Record Maintenance
    • Software Programs & Configuration
    • Recent Inspection Findings
    Electronic Signatures
    • Admissability
    • Signature Attributes
    • Linking a Signature to an Electronic Record
    • Identification Codes and Passwords
    • Digital Signatures
    • Recent Inspection Findings
    Operating Controls
    • Device Checks
    • Sequence Checks
    • Continuous Sessions System Access
    • Open and Closed Systems
    • Recent Inspection Findings
    Expected Good Practice
    • Validation
    • Backups & Archive
    • Training
    • Security
    • Business Continuity Plans
    • Recent Inspection Findings
    Implications for New Systems
    • Hazard Study
    • Common Practical Issues
    Implications for Existing Systems
    • Regulatory Expectations
    • Management Approach
    • Master Plans
    • Recent Inspection Findings
    15. Risk Management

    Project Initiation and Complicance Determination

    • Compliance Determination
    Requirements Capture and Supplier (Vendor) Selection
    • User Requirements Specification
    • upplier Assessment
    Design and Development
    • Design Specification (inc. Functional Specification)
    • Design Review
    Coding, Configuration, and Build
  • Programming Standards & Source Code Review Development Testing
    • upplier Testing
    User Qualification and Authorisation to Use
    • Data Loading
    • Installation Qualification
    • Operational Qualification
    • Performance Qualification
    • System Release
    Operation and Maintenance
    • Software Support
    • Service Level Agreements
    Phase-out Replacement
    • Archiving
    • Data Migration
    • Decommissioning
    16. Outsourcing

    Regulatory Requirements

    Planning and Supervision

    Organisational Capability

    Dis-entagnlement

    Ongoing Oversight

    17. Handling Legacy Systems

    Setting Priorities

    Hazard Control

    Interim Measures

    Validation Activities

    Recent Inspection Findings

    18. Regulatory Inspections

    Inspection Authority Inspection Practice

    • Approach to Organisational Capability
    • Approach to Individual Computer Systems
    • Mutual Recognition Agreements
    Inspection Process
    • Receiving an Inspection Request
    • Preparing for an Inspection
    • Hospitality
    • Arrival of the Inspector(s)
    • Conducting the Inspection
    • Daily Wash-Up with Inspector
    • After the Inspection
    • Inspection Findings
    • Poor Excuses
    • ISO 9000 and Validation
    Ensuring a State of Inspection Readiness
    • Inventory of Systems
    • System/Project Overviews
    • Validation Plans/Reports and Reviews
    • Documentation
    • Presentations
    • Internal Audit Program
    • Mock Inspections
    • Trained Personnel
    • Knowledge Management
    Providing Electronic Information During an Inspection
    • Provision of Electronic Documents and Reports
    • Provision of Electronic Copies of Desktop Applications
    • Provision of Electronic Records
    • Direct Access to Electronic Information by Regulators
    • Use of Computer Systems by Regulators
    • Copies of Electronic Information
    Inspection Analysis

    19. Capabilities and Performance

    Capability Management

    • Capability Appraisal
    • Capability Characteristics
    • Capability Assessment Outcomes
    • Supplier Capability Assessments
    Project Metrics
    • Design & Development Metrics
    • Testing Metrics
    • Understanding Contributory Factors
    Operation and Maintenance Maxims
    • Dependable Operation
    • Change Management
    Process Improvement
    • Lean
    • Six Sigma
    Index

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    Pharmaceutical Computer Systems Validation
    Quality Assurance, Risk Management
    and Regulatory Compliance
    Second Edition
    edited by Guy Wingate

    2009 • 832 pages • $598.95 + shipping
    Texas residents please add 6.75 % sales tax
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