Validation of Computerized Analytical Systems

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.

Computers & Technology

Huber, Ludwig

Programming

CRC-Press

This Second Edition discusses ways to improve pharmaceutical product quality while achieving compliance with global regulatory standards. With comprehensive step-by-step instructions, practical recommendations, standard operating procedures (SOPs), checklists, templates, and graphics for easy incorporation in a laboratory. This title serves as a complete source to the subject, and explains how to develop and implement a validation strategy for routine, non-routine, and standard analytical methods, covering the entire equipment, hardware, and software qualification process. It also provides guidance on qualification of certified standards, in-house reference materials, and people qualification, as well as internal and third party laboratory audits and inspections.

Validation and Qualification in Analytical Laboratories

Science & Math

Chemistry

Interpharm Press

Die Neue Nutzliche Bienenzucht Oder Der Dzierzonstock (1873) (German Edition)

Literature & Fiction

Literary

Kessinger Publishing, LLC

This scarce antiquarian book is a facsimile reprint of the original. Due to its age, it may contain imperfections such as marks, notations, marginalia and flawed pages. Because we believe this work is culturally important, we have made it available as part of our commitment for protecting, preserving, and promoting the world's literature in affordable, high quality, modern editions that are true to the original work.

Die Neue Nutzlichste Bienenzucht Oder Der Dzierzonstock (1888) (German Edition)

This book explains how to improve product quality while achieving compliance with the world's regulatory standards. A complete guide and reference, it teaches you how to develop and implement a validation strategy for routine, nonroutine, and standard analytical methods encompassing the entire equipment, hardware, and software qualification process. It includes examples and templates to help speed you through the validation process. Chromatographs, spectrophotometers, titrators, methods, reference compounds, and every possible item and category have been addressed. In addition to guidelines on the qualification of standards, certified and in-house reference materials, and employee qualification, it covers internal and third-party lab audits and inspections. Case studies, checklists, flowcharts, templates, and key SOPs support the text. All major regulations and quality standards are covered: US GLP, GMP, GCP, EN45001, ISO 9000 Series, NAMAS, ISO Guide 25, &amp; corresponding interpretation &amp; inspection guides.

Mathematics

You cannot afford to be in the dark when it comes to validating your analytical systems and lab software. Written by international laboratory and compliance expert Dr. Ludwig Huber, Validation of Computerized Analytical and Networked Systems is an invaluable validation tool. Covering the initial writing of the validation plan through implementation, testing, and installation qualification, through ongoing calibration, performance qualification, and change control, the book provides guidance throughout the entire validation process. Huber pays special attention to 21CFR Part 11 electronic records and signatures compliance, including recommendations for implementation and the scope of Part 11 for chromatographic systems. He discusses vendor assessment, covers the criteria and procedures for vendor audits, and includes vendor assessment checklists. He also explores the validation of complex networked systems and "office software" such as Macros, spreadsheets, and databases, and the operational compliance of legacy systems. The book contains everything you need to perform computer systems validation cost-effectively and in a manner acceptable to national and international regulatory agencies.

Validation of Computerized Analytical and Networked Systems

In this book, the major and at the same time most difficult questions of comparative cognition research - here called the sextet of animal intelligence - are presented using good examples, discussed in all their facets and finally answered with due caution. Starting with the question of human rationality, which is illuminated historically at the beginning and presented as a framework concept, the latest research is dealt with, which either revises preferred interpretation schemes or calls for new ones. It is particularly important to critically question hastily conceived categorisations, often derived from research on the human species and from everyday psychological notions, and to consider so-called animal irrationality, a.k.a. (mis)performance, from the perspective of species-specific, natural requirements. Why is it at all important to know whether animals can act rationally, intentionally or consciously? The answer is because it is of both theoretical and practical relevance. Theoretical relevance is twofold: because it is good in itself to understand animals better, but this knowledge is then also of great importance for assessing ourselves. This brings up the practical relevance: we are not only surrounded by animals, we live with animals, we live from animals. Yet we see ourselves as separate from them in important ways. Consciousness, language and rationality are essential characteristics with which we justify our human uniqueness and thus our superiority and ultimately our right to dominate and use animals in many ways. If an animal can feel pain, we feel obliged to avoid inflicting unnecessary pain on it. But yet we do not accord it the special inherent value and dignity associated with consciousness and rationality. This has far-reaching consequences for human action and the coexistence of humans and animals.

The Rational Animal: In Search of Complex Cognition in Non-Human Animals

Health, Fitness & Dieting

Psychology & Counseling

Springer

Das rationale Tier: Eine kognitionsbiologische Spurensuche

Suhrkamp Verlag AG

See the best price to sell, buy, or rent books by Huber, Ludwig. BookScouter helps to compare book prices from 25+ online bookstores and 30+ buyback vendors with a single search.

Books by Huber, Ludwig