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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 6: Understanding Software Categories and System Life Cycles
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. 167-193.
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In this chapter we will look at the first stage of risk assessment; the classification of software into various categories and the impact that this has on the corresponding system life cycles required for implementation and validation. Then, a system life cycle model for the validation of a CDS will be defined that will be used throughout the remainder of this book. From this life cycle we will derive the documented evidence required to demonstrate that the life cycle was followed and that will demonstrate that the CDS has been validated.
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