Ludwig Huber

Validation of Computerized Analytical Systems (eBook, ePUB)

• Format: ePub

Produktbeschreibung

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.

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Produktdetails

• Verlag: Taylor & Francis eBooks
• Seitenzahl: 268
• Erscheinungstermin: 28. April 2023
• Englisch
• ISBN-13: 9781000948226
• Artikelnr.: 67850443

Autorenporträt

Huber, Ludwig

Inhaltsangabe

Chapters include: Regulations and Standards Terminology Design
Qualification Vendor Assessment Validation During Development Installation
Qualification Operational Qualification Maintenance and Ongoing Performance
Qualification Validation of Macros and Spreadsheet Programs Qualification
of Networks Compliance with Electronic Records and Signatures (21 CFR Part
11) Operational Compliance of Legacy Systems Audits Appendices include:
Glossary and Standard Operating Procedures