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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 10: Writing the User and System Requirements
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. 303-318.
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The user requirements specification (URS) is the key document in the whole of the system life cycle. It is required for both business (investment protection) and regulatory reasons (defining intended purpose). Therefore, laboratory staff and validation teams must spend sufficient time defining and writing testable or verifiable user and system requirements. Without an adequate URS you cannot validate any computerised system.
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