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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 24: User Training and System Documentation
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Published:23 Nov 2016
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Special Collection: 2016 ebook collection
Page range:
484 - 512
Citation
Validation of Chromatography Data Systems: Ensuring Data Integrity, Meeting Business and Regulatory Requirements, The Royal Society of Chemistry, 2nd edn, 2016, pp. 484-512.
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Successful installation and validation of a CDS also requires effectively trained users using good documented procedures. Supplier documentation also provides reference material that will be used to back up procedures and provide reference material for user. Together, these contribute to the controlled function elements of computerised system validation described in Chapter 5.
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