Descrição
CONTENTS:
The Data Integrity Issue Section
Introduction by Siegfried Schmitt
History of Data Integrity in the Life Sciences by Jim P. Stumpff
Data Integrity Regulatory Enforcement by Siegfried Schmitt
Clinical Trial Data Integrity Assessments by Yingying Liu and Siegfried Schmitt
The Preventing Data Integrity Problems Section
Management Strategies for Data Integrity by Ronald F. Tetzlaff
Data Integrity Considerations in Automated Systems by Joe Liscouski
Controls to Ensure Laboratory Data Integrity by R. D. McDowall
Data Integrity in the Laboratory by Jeanne Moldenhauer
Data Integrity Practical Aspects from an Instrument Suppliers Perspective by Christoph Jansen
Data Life Cycle Considerations for Data Integrity in Automated Systems by Joseph Liscouski
The Data Integrity Life Cycle Risks and Mitigation by David Stokes
Incorporating Data Integrity into the Quality System by Siegfried Schmitt
Big Data by Magdalena Kurpierz
Data Reproducibility and Data Quality by Joseph Liscouski
A Burden Worth Bearing by Alicia Pruett
Regulatory Overview: Data Integrity by Maryann Gribbin and Kir Henrici
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
