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December 01, 2017
Good practice (GxP) regulations require an instrument maintenance and use log. Have spectroscopy laboratories and software suppliers emerged from the Middle Ages yet?
September 01, 2017
The new version of United States Pharmacopeia general chapter “Analytical Instrument Qualification” became effective August 1, 2017. What does this mean for you?
April 01, 2017
Data integrity requires a multilayered approach that runs throughout a regulated organization. Here we discuss the laboratory level.
September 01, 2016
In April 2016, the FDA issued a draft guidance for industry on data integrity and compliance with cGMP. What does this mean for the laboratory?