Validation of Computerized Analytical Systems

ISBN-13: 9780935184754 / Angielski / Twarda / 1995 / 264 str.

Ludwig Huber; Huber Huber

Opis

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.

Spis treści

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

O autorze

Huber, Ludwig