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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 34: CDS Records Retention
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. 657-675.
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Retention of records generated by a CDS is an important requirement under existing GXP rules that were written when paper was king. Electronic records generated by a CDS will usually outlive the system that generated them. Records retention is the biggest problem facing any CDS, especially if it is used as a hybrid system.
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