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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 17: Importance of the Traceability Matrix
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. 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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