Assuring Data Integrity for Life Sciences (Hardcover)

Mar 2016
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This new book provides a truly global perspective on data integrity and the solutions available to address this serious issue. It includes two main sections: the regulatory and historic background of data integrity, and practical advice on how to prevent or rectify data integrity breaches.

Each chapter is written by renowned, highly experience subject matter experts in the fields of compliance and data integrity, and includes a "how to" section with practical, implementable advice. Content is up to date with the latest regulations and guidances, making this the most relevant reference source of its kind. Useful checklists and aide memoirs can be customized by the discerning reader. This book should be equally useful for the quality unit professional, operations manager, validation experts and regulators.

The modular structure allows readers to pick chapters of special interest without having to reach the chapters in order. However, given the usefulness and universal application the "nuggets of wisdom" and advice provided, it is anticipated that readers will want to read the publication in its entirety.

Click here to order the single user digital version (Item no. 18016).

Table of Contents

Table of Contents:

Click here to download >>>Detailed Table of Contents

The Data Integrity Issue Section

  1. Introduction by Siegfried Schmitt
  2. History of Data Integrity in the Life Sciences by Jim P. Stumpff
  3. Data Integrity Regulatory Enforcement by Siegfried Schmitt
  4. Clinical Trial Data Integrity Assessments by Yingying Liu and Siegfried Schmitt

    The Preventing Data Integrity Problems Section

  5. Management Strategies for Data Integrity by Ronald F. Tetzlaff
  6. Data Integrity Considerations in Automated Systems by Joe Liscouski
  7. Controls to Ensure Laboratory Data Integrity by R. D. McDowall
  8. Data Integrity in the Laboratory by Jeanne Moldenhauer
  9. Data Integrity — Practical Aspects from an Instrument Supplier's Perspective by Christoph Jansen
  10. Data Life Cycle Considerations for Data Integrity in Automated Systems by Joseph Liscouski
  11. The Data Integrity Life Cycle — Risks and Mitigation by David Stokes
  12. Incorporating Data Integrity into the Quality System by Siegfried Schmitt
  13. Big Data by Magdalena Kurpierz
  14. Data Reproducibility and Data Quality by Joseph Liscouski
  15. A Burden Worth Bearing by Alicia Pruett
  16. Regulatory Overview: Data Integrity by Maryann Gribbin and Kir Henrici
  17. The Data Integrity Management System Incorporating Data Integrity into the Quality System by Maryann Gribbin and Kir Henrici

Appendix: Data Life Audit Aide Memoire by Siegfried Schmitt

About the Authors

About the Editor

Dr. Siegfried Schmitt, has over 25 years of experience in the healthcare industry in roles covering manufacturing and Quality Control and Quality Assurance to consulting roles for a wide range of products, processes and systems. A particular area of interest is computerized systems compliance, which complements other areas of special interest, such as Quality by Design and Data Integrity. Dr Schmitt is a Fellow of the Royal Society of Chemistry, Chartered Chemist and Chartered Scientist. He has published widely in various journals and has been the editor or various journals and books. He is also a member of various industry associations and he is the present PDA UK Chapter president