Validation of Computerized Analytical Systems

Ludwig Huber

• Publisher: CRC Press
• Year: 2023
• Print ISBN: 9780367401726
• eBook ISBN: 9781000948226
• Topic: Medicine
• Subtopic: Pharmacology

Validation of Computerized Analytical and Networked Systems provides the definitive rationales, logic, and methodology for validation of computerized analytical systems. Whether you are involved with formulation or analytical development laboratories, chemical or microbiological quality control laboratories, LIMS installations, or any aspect of robotic in a healthcare laboratory, this book furnishes complete validation details. International and FDA regulations and requirements are discussed and juxtaposed with numerous practical examples that show you how to cost-effectively and efficiently accomplish validation acceptable to FDA GCP/GLP/GMP, NAMAS, and EN45001 standards. The templates included provide documentation examples and the many checklists found throughout the book assure that all aspects of covered in a logical sequence. The chapters describe and explain such topics as the Product Life Cycle revalidation, change control, documentation requirements, qualifications, testing, data validation and traceability, inspection, SOPs, and many other that help streamline the validation process.

Table of contents

• Cover
• Title
• Copyright
• Preface
• Contents
• 1. Introduction
• 2. Regulations and Quality Standards
• 3. Definitions: Computer Systems, Computerized Systems and Software
• 4. Validation Processes in the Analytical Laboratory
• 5. Life Cycle Approach for Validation of Software and Computer Systems
• 6. Validation Efforts at the Vendor's Site
• 7. Responsibilities of Vendors and Users
• 8. Calibration, Verification and Validation of Equipment
• 9. Selection and Qualification of a Vendor
• 10. Installation and Operation
• 11. Validation of Analytical Methods
• 12. Maintenance and Ongoing Performance Control
• 13. Testing of Chromatographic Computer Systems
• 14. Data Validation, Audit Trail, Security and Traceability
• 15. Diagnostics, Error Recording and Reporting
• 16. Audit/Inspection of Computerized Systems
• Appendix A. Glossary
• Appendix B. (Standard) Operating Procedures
• Appendix C. Strategy for Chronological Selection and Validation of Computerized Analytical Systems
• Appendix D. Testing of Selected Equipment
• References
• Indexes