Data Integrity and Compliance
eBook - ePub

Data Integrity and Compliance

A Primer for Medical Product Manufacturers

  1. 279 pages
  2. English
  3. ePUB (mobile friendly)
  4. Available on iOS & Android
eBook - ePub

Data Integrity and Compliance

A Primer for Medical Product Manufacturers

About this book

Data integrity is a global mandatory requirement for the regulated healthcare industry. It is more than a mere expectation-it's a basic element of good documentation practices, one of the most fundamental pillars of a quality management system. Robustness and accuracy of the data submitted by manufacturers to regulatory authorities when bringing a medical product to market are crucial.The purpose of this book is to consolidate existing data integrity principles and expectations from several regulatory sources-including the U.S. Food and Drug Administration, World Health Organization, and European Medicines Agency-into a single and handy document that provides detailed, illustrative implementation guidance. It serves as a means of understanding regulatory agencies' position on good data management and the minimum expectation for how medical product manufacturers can achieve compliance.

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Yes, you can access Data Integrity and Compliance by José Rodríguez-Pérez in PDF and/or ePUB format, as well as other popular books in Business & Operations. We have over one million books available in our catalogue for you to explore.

Information

Publisher
ASQ Quality Press
Year
2019
Print ISBN
9780873899871
eBook ISBN
9781951058487
Topic
Business
Subtopic
Operations
Index
Business

Table of contents

  1. Acronyms
  2. Preface
  3. Chapter 1. Introduction
  4. Chapter 2. Data Integrity and Good Documentation Practices
  5. Chapter 3. ALCOA: Expectations and Examples
  6. Chapter 4. Regulatory Expectations
  7. Chapter 5. Regulatory Enforcement
  8. Chapter 6. Data Life Cycle
  9. Chapter 7. Integrating Data Integrity into the Quality System
  10. Chapter 8. Clinical Data Integrity
  11. Chapter 9. Preventing Data Integrity Problems
  12. Chapter 10. Data Governance and Data Integrity Audit
  13. Chapter 11. Good Documentation Practices and Data Integrity Training
  14. Chapter 12. Investigating and Disclosing Data Integrity Issues
  15. Chapter 13. Data Integrity for Outsourced Activities
  16. Chapter 14. Maintaining Integrity of Electronic Data
  17. Appendix A. Examples of FDA’s Enforcement Actions for Data Integrity Problems
  18. Appendix B. An Example of Data Integrity Training Certification
  19. Appendix C. Guidelines for Auditing ALCOA Principles for Paper and Electronic Documents
  20. Bibliography