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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 19: Writing the Technical Specification
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Published:23 Nov 2016
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Special Collection: 2016 ebook collection
Page range:
412 - 417
Citation
Validation of Chromatography Data Systems: Ensuring Data Integrity, Meeting Business and Regulatory Requirements, The Royal Society of Chemistry, 2nd edn, 2016, pp. 412-417.
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The technical specification defines the computer platform components (hardware, software, data storage, etc.) that a CDS will run on. For a standalone system involving a single workstation this can be incorporated adequately in the URS, but this is not recommended for regulated work. For multi-user systems housed on one or more servers in a data centre or computer room, a technical specification is required.
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