Validation of Chromatography Data Systems: Ensuring Data Integrity, Meeting Business and Regulatory Requirements
CHAPTER 16: CSV Risk Management Requirements Level Assessment
Published:23 Nov 2016
Validation of Chromatography Data Systems: Ensuring Data Integrity, Meeting Business and Regulatory Requirements, The Royal Society of Chemistry, 2nd edn, 2016, pp. 368-385.
Download citation file:
This chapter follows on from our initial discussion of risk assessment of the overall system in Chapter 8. In this chapter, we move to the next stage of risk management: risk assessment conducted at the requirements level. The aim is to ensure that there are sufficient controls in place to mitigate risks to the system and to the data generated by it and to focus testing on critical portions of the CDS. Remember also that in Chapter 6 there is an analysis of the GAMP software categories of the functions within a typical CDS application, which is another area of risk assessment. In this chapter we will consider two methodologies for risk assessment at the requirements level: functional risk assessment (FRA) and qualitative version of failure mode effects analysis (FMEA).