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Subjects
Drugs, Standards, Computer security, Pharmaceutical industry, Quality control, Pharmaceutical Preparations, Computer Security, Equipment and Supplies, Quality Control, Drug Industry, Data Accuracy, Médicaments, Normes, Sécurité informatique, Industrie pharmaceutique, Qualité, Contrôle, Qualité des donnéesPlaces
United States, États-UnisShowing 1 featured edition. View all 1 editions?
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Data integrity and compliance: a primer for medical product manufacturers
2019, ASQ Quality Press
in English
195105847X 9781951058470
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Book Details
Table of 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.
Edition Notes
Includes bibliographical references and index.
Classifications
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