DATA INTEGRITY and DATA MANAGEMENT for GXP REGULATED FIRMS
Barbara Unger · 2016
In three blog entries I provide a structured look at the topic and include links to relevant documents and an extensive list of primary references with links. You will learn about the regulatory enforcement background and why we’ve arrived at the point where data integrity is such a significant focus; you will learn about the applicable regulations and guidance and the enforcement actions taken by global regulatory authorities in this area and you will learn what actions you can take within your own company to begin to address the topic and you will have links to the relevant references. This report includes the following divided as follows: