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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 17: Importance of the Traceability Matrix
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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. 386-402.
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The purpose of a traceability matrix is to show where in the life cycle a user requirement can be met either by testing (directly or indirectly) or by verification (e.g. delivery of a document or by a documented action). In this chapter we will look at what a traceability matrix is and its role in a CDS validation project and when this document should be written. From my perspective, a traceability matrix is an essential tool to help you control the detailed steps of any computer validation project, including a CDS.
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