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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 4: Applicable GXP Regulations and Guidance for CSV
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. 74-146.
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Understanding and interpreting the GXP regulations that a chromatography data system operates under is crucial to ensuring that the validation work is correct and meets the spirit and intent of the law. Where regulations are vague regulatory agencies often issue guidance, as do scientific societies and industry bodies, to help interpret the regulations.
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