CHAPTER 9: An Analytical Data Life Cycle Check Access

Many of the regulatory guidance documents mention a data life cycle from initial generation through processing to reporting, retention and finishes with the destruction of the records. These discussions involve outline definitions or generic life cycles that are not specific to a regulated laboratory and can be rather vague. In this chapter, a flexible analytical data life cycle that is sample centric is presented and discussed. When considering an analytical data life cycle, the concept also includes raw data and complete data that were discussed in Chapters 3 and 7 and it is on the basis of understanding of the meaning of these two terms that the discussion of an analytical data life cycle will be presented. The aim of this chapter is to ensure that a complete data life cycle from an analytical perspective is presented to ensure that all data are captured and managed correctly. It also allows a laboratory to identify the areas that have a greater risk where controls and data audits should place more emphasis to ensure that data integrity is ensured. Understanding the phases of an analytical data life cycle allows an effective assessment and remediation of processes and systems that will be discussed in Chapter 10.