Validation of Computerized Analytical Systems: 1st Edition (Hardback) book cover

Validation of Computerized Analytical Systems

1st Edition

By Ludwig Huber

CRC Press

264 pages

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Hardback: 9780935184754
pub: 1995-05-31
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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

Chapters include:

Regulations and Standards


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


Appendices include: Glossary and Standard Operating Procedures

Subject Categories

BISAC Subject Codes/Headings:
MEDICAL / Pharmacology