Computer systems validation : quality assurance, risk management, and regulatory compliance for pharmaceutical and healthcare companies /: quality assurance, risk management, and regulatory compliance for pharmaceutical and healthcare companies. (©2004)

• Record Type: Book
• Further Information: Note: Edited by Guy Wingate.
• Other Names: Wingate, Guy
• 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
• Publisher Details: Boca Raton, FL : Interpharm/CRC
• Publication Date: 2004
• Copyright Date: 2004
• Extent: 1 online resource (994 pages), illustrations
• Subjects: 338.4/76151/0285; Pharmaceutical industry -- Management; Pharmaceutical industry -- Data processing; Health facilities -- Risk management; Risk management -- Data processing; Computer Systems -- standards; Drug Industry -- standards; Drug Industry -- instrumentation; Guideline Adherence; Health Care Sector -- standards; Quality Control; Software Validation; BUSINESS & ECONOMICS -- Industries -- Pharmaceutical & Biotechnology; Health facilities -- Risk management; Pharmaceutical industry -- Data processing; Pharmaceutical industry -- Management; Risk management -- Data processing; Electronic books
• Languages: English
• ISBNs: 0203494245; 9780203494240; 9780849318719; 0849318718
• Related ISBNs: 0849318718
• Notes: Note: Includes bibliographical references and index.; Note: Print version record.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.