CHAPTER 10: Assessment and Remediation of Laboratory Processes and Systems Check Access

A key part of any data integrity programme is the examination and understanding of system and process risk for data and records created and maintained during GXP activities. This discussion was started in Chapter 9 with an exploration of the flexible analytical data integrity life cycle and the risk that some activities have compared with others. In this chapter, we will discuss ways of formally assessing both manual processes as well as those involving computerised systems to identify record vulnerability and propose remediation in the short term and well as develop long-term solutions to eliminate paper and generate business benefit. However, some companies focus only on computerised systems for this and ignore manual processes that leave potential compliance gaps. Process and system assessments based on questionnaires can have limitations as this can be a proscriptive approach and where there is a gap in the questionnaire there will be a gap that would be overlooked. An alternative approach is to use data flow mapping (a combination of process mapping combined with the identification of data and records generated and modified during the execution of a process). This is a methodology that allows the visualisation of the current process and following any remediation. Data process mapping is applicable to both manual processes and computerised systems.