CHAPTER 5: A Data Integrity Model Check Access

Understanding the scope of a data integrity and data governance programme is essential to ensure that all work is undertaken and that there are no regulatory gaps left that could result in a citation during an inspection. The full scope of a data integrity and data governance programme is very extensive, as we have seen in Chapter 4. One of the tasks of senior management is to communicate the DI programme and expectations throughout a regulated organisation. As the data integrity guidances from regulatory agencies have little in the way of a structured approach to the topic there is no easy way to understand the full scope of the problem. This is where a Data Integrity Model is useful to visualise the subject and should be the vehicle to understand the topic that will be presented and discussed in this chapter. As we shall see again, data integrity is not just about numbers. It is much more than that, as can be seen with the scope of the Data Integrity Model. You will recall that the laboratory portion of the Data Integrity Model was introduced in Chapter 1 where the chapters of the book were plotted against the various levels, however, this chapter provides the full understanding of the Model.