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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 32: Change Control and Configuration Management
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Published:23 Nov 2016
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Special Collection: 2016 ebook collection
Citation
Validation of Chromatography Data Systems: Ensuring Data Integrity, Meeting Business and Regulatory Requirements, The Royal Society of Chemistry, 2nd edn, 2016, pp. 608-627.
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After operational release comes the most difficult part of computerised system validation; maintaining the validation status of the system throughout its whole operational life. The key challenge here is effective change control coupled with configuration management.
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