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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
Publication date:
23 Nov 2016
Book Chapter
CHAPTER 8: CDS Validation: Managing System Risk
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Published:23 Nov 2016
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Special Collection: 2016 ebook collection
Citation
Validation of Chromatography Data Systems: Ensuring Data Integrity, Meeting Business and Regulatory Requirements, The Royal Society of Chemistry, 2nd edn, 2016, pp. 266-283.
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Risk assessment and risk management are essential elements of a computerised system validation project. In this chapter we will consider the assessment of the risk posed by the overall system and later in this book Chapter 16 will discuss the risk assessment of the individual system requirements and functions.
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