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RSC Chromatography Monographs
Validation of Chromatography Data Systems: Ensuring Data Integrity, Meeting Business and Regulatory Requirements
Director, R.D.McDowall Ltd
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23 Nov 2016
CHAPTER 8: CDS Validation: Managing System Risk
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. 266-283.
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Risk assessment and risk management are essential elements of a computerised system validation project. In this chapter we will consider the assessment of the risk posed by the overall system and later in this book Chapter 16 will discuss the risk assessment of the individual system requirements and functions.
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