Data integrity and compliance
Subtitle: a primer for medical product manufacturers
By: Jose Rodríguez-Pérez, PhD
Contributors: American Society for Quality
Publisher: ASQ Quality Press
Published: 2019
Place of publication: Milwaukee, Wisconsin
Language: eng
Number of pages: 253
ISBN-13: 9781951058470; 9780873899871
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 données
Notes: Includes bibliographical references and index.
Table of contents: title: Data integrity and good documentation practices; title: ALCOA : expectations and examples; title: Regulatory expectations; title: Regulatory enforcement; title: Data life-cycle; title: Integrating data integrity into the quality system; title: Clinical data integrity; title: Preventing data integrity problems; title: Data governance and data integrity audit; title: Good documentation practices and data integrity training; title: Investigating and disclosing data integrity issues; title: Data integrity for outsourced activities; title: Maintaining integrity of electronic data.