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Science/Engineering Statistical Mechanics, Third Edition
Science/Engineering Essentials of Toxic Chemical Risk: Science and Society
Science/Engineering Telefoncoaching: So machen Sie aus Ihren Mitarbeitern Telefonprofis
Science/Engineering Wireless Communications (Wiley - IEEE)
Science/Engineering Posttraumatische Belastungsstörungen (German Edition)
Science/Engineering Lernplattformen in Schulen: Ansätze für E-Learning und Blended Learning in Präsenzklassen (1 Auflage)
Science/Engineering Stochastik für Einsteiger: Eine Einführung in die faszinierende Welt des Zufalls. Mit über 220 Übungsaufgaben und Lösungen {Repost}
Science/Engineering Testtheorie und Fragebogenkonstruktion (Springer-Lehrbuch)
Science/Engineering Centrifugal Pumps, 2nd Edition
Science/Engineering Computational Intelligence for Modelling and Prediction (Studies in Computational Intelligence) 1 edition {Repost}
Science/Engineering Networks, Crowds, and Markets: Reasoning About a Highly Connected World {repost}
Science/Engineering Introduction to Biophotonics (repost)
Science/Engineering The Art and Science of Psychotherapy (repost)
Science/Engineering Advances in Chemical Physics - Volume 15: Stochastic Processes in Chemical Physics
Science/Engineering "Emulsion Science: Basic Principles" (repost)
Science/Engineering Elementary Principles of Chemical Processes 3rd edition
Science/Engineering Boundary Element Analysis (repost)
Science/Engineering Collection of books on physics 2
Science/Engineering A Practical Handbook of Preparative HPLC by Donald A. Wellings (Repost)
Science/Engineering Reviews of Environmental Contamination and Toxicology 184 by George W. Ware
Science/Engineering Essentials of Toxic Chemical Risk: Science and Society
Science/Engineering Telefoncoaching: So machen Sie aus Ihren Mitarbeitern Telefonprofis
Science/Engineering Wireless Communications (Wiley - IEEE)
Science/Engineering Posttraumatische Belastungsstörungen (German Edition)
Science/Engineering Lernplattformen in Schulen: Ansätze für E-Learning und Blended Learning in Präsenzklassen (1 Auflage)
Science/Engineering Stochastik für Einsteiger: Eine Einführung in die faszinierende Welt des Zufalls. Mit über 220 Übungsaufgaben und Lösungen {Repost}
Science/Engineering Testtheorie und Fragebogenkonstruktion (Springer-Lehrbuch)
Science/Engineering Centrifugal Pumps, 2nd Edition
Science/Engineering Computational Intelligence for Modelling and Prediction (Studies in Computational Intelligence) 1 edition {Repost}
Science/Engineering Networks, Crowds, and Markets: Reasoning About a Highly Connected World {repost}
Science/Engineering Introduction to Biophotonics (repost)
Science/Engineering The Art and Science of Psychotherapy (repost)
Science/Engineering Advances in Chemical Physics - Volume 15: Stochastic Processes in Chemical Physics
Science/Engineering "Emulsion Science: Basic Principles" (repost)
Science/Engineering Elementary Principles of Chemical Processes 3rd edition
Science/Engineering Boundary Element Analysis (repost)
Science/Engineering Collection of books on physics 2
Science/Engineering A Practical Handbook of Preparative HPLC by Donald A. Wellings (Repost)
Science/Engineering Reviews of Environmental Contamination and Toxicology 184 by George W. Ware
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Science/Engineering Testing Computers Systems for FDA/MHRA Compliance (Computer Systems Validation Life Cycle Activities)
Posted on 2010-03-16
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More Testing Computers Systems for FDA/MHRA Compliance (Computer Systems Validation Life Cycle Activities) There is no substitute for extensive testing when it comes to IT systems. Recognition that problems are easier and cheaper to fix before the system is in use (rather than after), has turned testing into a cost-effective tool. However, when developing computer systems for pharmaceuticals manufacturing, testing to meet regulatory requirements adds an additional layer of complexity. Testing Computers Systems for FDA/MCA Compliance focuses on software module, software integration, hardware, and system acceptance testing. Reflecting the renewed emphasis of the FDA and other global regulatory agencies towards systematic inspections and risk-based validation with an underlying scientific rationale, this guide focuses on current best practices in computer systems testing in the regulatory environment. David Stokes demonstrates how the principles detailed in the GAMP 4 Guide can be used to define a pragmatic approach to testing. He includes techniques for testing large Internet-based systems for compliance with the stringent requirements of regulations such as 21CFR Part 11, and clarifies the relationship and responsibilities of the system "user" and "supplier".
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