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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 28: Writing the Validation Summary Report
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. 562-568.
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The validation summary report brings together all of the documentation collected throughout the whole of the life cycle and presents a recommendation for management approval when the system is validated. The document should also contain a formal release statement to allow the system to be used for regulated work.
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