CHAPTER 16: Performing an Analysis Check Access

We have waited until Chapter 16 to get to the heart of data integrity with the focus on sample analysis. However, the preceding chapters are essential to understanding, via the Data Integrity Model, of what an organisation and regulated laboratory needs to have in place to ensure data integrity before any analysis occurs, e.g. management leadership, an open culture, data integrity policies and procedures, trained staff, qualified analytical instruments with validated computerised systems and validated analytical procedures. These elements are all applied to the analysis of samples that we will discuss in this chapter. This chapter focuses on Level 3 of the Data Integrity Model – the execution of a validated analytical procedure to analyse samples and generate reportable results. As discussed in Chapter 9, the analytical life cycle can encompass sampling, sample management, sample preparation, instrumental analysis, interpretation of analytical data and the generation of the reportable result in part or in whole. This work may be performed by a single analyst or by a group of analysts but excludes the second person review, which is presented in Chapter 17. Sample analysis is where most of poor data management practices or data violations are seen but often the root causes of these problems are found in the underlying layers of the Data Integrity Model.