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Computerized Data Systems

DIA Peach BookComputerized Systems in Clinical Research: Current Data Quality and Data Integrity Concepts, applies and further develops the standards set forth through the Red Apple II GLP DIA initiative. This initiative is intended to set a benchmark for requirements of computerized systems used in clinical research. It is simultaneously intended to support the many users struggling to implement validation processes into clinical research, thus stimulating innovation in the clinical research environment. Proper validation and use of computerized systems will help ensure the safety of subjects and the credibility of clinical research data.

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Red Apple IIComputerized Data Systems for Nonclinical Safety Assessment: Current Concepts and Quality Assurance. This second edition explores the current environment and new challenges in the development, validation, and use of computerized systems in nonclinical laboratories and describes the best practices to ensure their quality at that time.