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Validation of quantitative liquid chromatography—mass spectrometry software for good laboratory practice compliance

✍ Scribed by J. Moore; P. Solanki; R.D. McDowall

Publisher
Elsevier Science
Year
1995
Tongue
English
Weight
313 KB
Volume
31
Category
Article
ISSN
1381-141X

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✦ Synopsis

The application of the UK Department of Health Good Laboratory Practice (GLP) guidelines to computer systems is discussed including the scope of an inspection of a computer system for compliance. A validation case history of software for quantitative liquid chromatography-mass spectrometry is reviewed including generation of the validation test plan and brief details of the validation tests performed. Tests for system security, sample continuity, accuracy of integration, accuracy of calibration, and integrity of data exported from the system are described..

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