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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 31: Incident and Problem Management
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. 598-607.
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Incidents and problems will occur during the operational lifetime of a CDS, and these events need to be documented, classified, investigated and where appropriate resolved. At times, problems and sometimes incidents lead to a change request that is covered in Chapter 32.
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