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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 10: Writing the User and System Requirements
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Published:23 Nov 2016
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Special Collection: 2016 ebook collection
Page range:
303 - 318
Citation
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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