Validation of Computerized Analytical Systems
Auteur : Huber Ludwig
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.
Date de parution : 10-2019
17.8x25.4 cm
Thème de Validation of Computerized Analytical Systems :
Mots-clés :
Computerized Analytical Systems; Good Automated Laboratory Practices; Chromatography Data System; VDE; Computer System Validation; System Suitability Testing; Software Validation; Hewlett Packard ChemStations; UV Visible Detector; GLP Regulation; GLP Principle; FDA Investigator; HPLC System; Software Development Standards; Anticipated Operating Range; LIMS; Standard Applications Software; Automated Data Collection Systems; Error Handling; HPLC Module; Computer System Audits; FDA Audit; GLP Study; Chromatography Software; Hardware Validation