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RSC Chromatography Monographs
Validation of Chromatography Data Systems: Ensuring Data Integrity, Meeting Business and Regulatory Requirements
By
Robert McDowall
Robert McDowall
Director, R.D.McDowall Ltd
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Hardback ISBN:
978-1-84973-662-6
PDF ISBN:
978-1-78262-407-3
EPUB ISBN:
978-1-78262-980-1
Special Collection:
2016 ebook collection
No. of Pages:
733
Published online:
23 Nov 2016
Published in print:
25 Nov 2016
Book Chapter
CHAPTER 34: CDS Records Retention
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Published:23 Nov 2016
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Special Collection: 2016 ebook collection
Page range:
657 - 675
Citation
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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