Validation of Chromatography Data Systems: Ensuring Data Integrity, Meeting Business and Regulatory Requirements
CHAPTER 29: Integration in a Regulated Environment
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. 569-585.
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A number of questions keep raising their heads around integration of chromatographic peaks when working in a regulated laboratory. Can chromatographers integrate peaks manually? If they can integrate manually, when can they do it? Also, if they can manually integrate, when should they not do it? Indeed, what is the definition of manual integration? These are key data integrity questions that must be answered for a chromatography data system. It is essential that chromatographic integration is adequately controlled and that there is a balance between regulatory compliance and chromatographic science.