Title Data integrity and compliance : a primer for medical product manufacturers / Jose Rodríguez-Pérez, PhD

Published Milwaukee, Wisconsin : ASQ Quality Press, [2019]

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Description 1 online resource (xx, 253 pages) Contents Data integrity and good documentation practices -- ALCOA : expectations and examples -- Regulatory expectations -- Regulatory enforcement -- Data life-cycle -- Integrating data integrity into the quality system -- Clinical data integrity -- Preventing data integrity problems -- Data governance and data integrity audit -- Good documentation practices and data integrity training -- Investigating and disclosing data integrity issues -- Data integrity for outsourced activities -- Maintaining integrity of electronic data Bibliography Includes bibliographical references and index Notes Print version record Subject Drugs -- Standards -- United States Computer security -- Standards -- United States Pharmaceutical industry -- Standards -- United States Quality control. Pharmaceutical Preparations -- standards Computer Security -- standards Equipment and Supplies -- standards Quality Control Drug Industry -- standards Data Accuracy quality control. Quality control Computer security -- Standards Drugs -- Standards Pharmaceutical industry -- Standards SUBJECT United States https://id.nlm.nih.gov/mesh/D014481 Subject United States Form Electronic book Author American Society for Quality, issuing body. ISBN 9781951058470 195105847X

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