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

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 & 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