| Description |
1 online resource (258 pages) |
| Contents |
Front cover; Contents; Foreword; Preface; Publisher's Note; CH 1 Introduction; CH 2 Validation Overview; WHAT IS A COMPUTER SYSTEM?; WHAT IS A COMPUTER SYSTEMS VALIDATION?; WHY DO WE VALIDATE COMPUTER SYSTEMS?; KEY PROJECT ELEMENTS; WHICH SYSTEMS SHOULD BE VALIDATED?; INTRODUCTION TO THE COMPUTER SYSTEMS VALIDATION PROCESS; COMPUTER SYSTEMS VALIDATION FOR LOW-CRITICALITY AND/OR LOW COMPLEXITY PROJECTS; CH 3 USA Regulatory Requirements for Computer Systems1; MEDICAL DEVICES SOFTWARE; THE FOOD INDUSTRY; CH 4 New Computer Systems Validation Model1; CH 5 Computer Validation Management Cycle |
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VALIDATION POLICIES1VALIDATION GUIDELINES; VALIDATION PLANS; PROCEDURAL CONTROLS; COMPLIANCE ASSESSMENTS; VALIDATION OF COMPUTER SYSTEMS; SUPPLIER QUALIFICATION; ONGOING SUPPORT SYSTEMS; CH 6 Computer Validation Program Organization; ORGANIZATIONAL MODEL; COMPUTER SYSTEMS VALIDATION EXECUTIVE COMMITTEE; CSV CROSS-FUNCTIONAL TEAM; CSV GROUPS AND TEAMS; THE MANAGEMENT GROUP; VALIDATION PROGRAM COORDINATORS; CH 7 The Computer Systems Validation Process; SYSTEM DEVELOPMENT FILES; CH 8 Validation Project Plans and Schedules; REGULATORY GUIDANCE; VALIDATION PROJECT PLANS; MANDATORY SIGNATURES |
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PROJECT SCHEDULECH 9 Inspections and Testing; REGULATORY GUIDANCE1 Structural Testing; Static Verifications; Functional Testing; Program Build Testing; INTRODUCTION; DOCUMENT INSPECTIONS AND TECHNICAL REVIEWS; WHITE BOX TESTING; Code Reviews, Inspections, and Audits; Unit Testing; BLACK BOX TESTING; Transaction Flow; Domain Testing; State Transitions; Function Equivalence; Load Testing; Configuration Testing; System Security Testing; Regression Testing; Storage Use Testing; OTHER TESTING TYPES Program Build Testing; CH 10 Qualifications; INTRODUCTION |
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HARDWARE INSTALLATION QUALIFICATION2 ObjectiveSOFTWARE INSTALLATION QUALIFICATION Objective; SYSTEM OPERATIONAL QUALIFICATION Objective; SYSTEM PERFORMANCE QUALIFICATION Objective; OPERATING SYSTEM AND UTILITY SOFTWARE INSTALLATION VERIFICATION Introduction; STANDARD INSTRUMENTS, MICROCONTROLLERS, SMART INSTRUMENTATION VERIFICATION Introduction; STANDARD SOFTWARE PACKAGES QUALIFICATION Introduction; A RELATED PRODUCT FOR ISO/IEC 12119, THE IEEE STANDARD ADOPTION OF ISO/IEC 12119 Objective; CONFIGURABLE SOFTWARE QUALIFICATION Introduction; CUSTOM-BUILT SYSTEMS QUALIFICATION Introduction |
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CH 11 SLC DocumentationREGULATORY GUIDANCE; SLC DOCUMENTATION; CH 12 Relevant Procedural Controls; CH 13 Change Management; INTRODUCTION; CHANGE MANAGEMENT PROCESS; Assessing the Risk, Criticality, and Impact of Change; Specification of the Testing Requirements and Acceptance Criteria, and Implementation of Change after Authorization; Performing Applicable Regression Testing; Reviewing the Change(s) with an Independent Reviewer; CH 14 Training; REGULATORY GUIDANCE1; TRAINING IN THE REGULATED INDUSTRY; CH 15 Security; REGULATORY GUIDANCE1; INTRODUCTION; PHYSICAL SECURITY; NETWORK SECURITY |
| Summary |
Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance with worldwide computer systems validation regulations. The author introduces supporting technologies such as encryption and digital signatures and places regulatory compliance within the context of quality assurance. He demonstrates the importance of integrating validation activities into the system lifecycle using a structured top-down approach. He covers practical applications of quality assurance |
| Notes |
Applications security |
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Print version record |
| Subject |
Computer programs -- Verification.
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Computer software -- Validation.
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Pharmaceutical industry.
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Software Validation
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Drug Industry
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Computer programs -- Verification
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Computer software -- Validation
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Pharmaceutical industry
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| Form |
Electronic book
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| ISBN |
9781135488765 |
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1135488762 |
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