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© 2021 MJH Life Sciences and Spectroscopy Online. All rights reserved.
© 2021 MJH Life Sciences™ and Spectroscopy Online. All rights reserved.
November 01, 2021
In the first article of a two-part series, the new PIC/S guidance is discussed, with particular focus on the scope, data governance, and paper records.
September 01, 2021
Computerized system validation (CSV) has an uninspiring reputation for
being a slow, no-value-added activity that only wastes time and delays the
implementation of new software. Is that an accurate portrayal? And is it a
April 01, 2021
“SneakerNet,” or the manual transfer of data using a disk or USB stick from one computer system to another, should be long dead, but this noncompliant transfer process still survives.
January 12, 2021
December 01, 2020
The calibration and qualification of analytical systems is a journey, not an event.
November 01, 2020
Two recent warning letters show that the US FDA is substantially increasing the amount of remediation work it requires for companies to correct data integrity noncompliance. That work can be very expensive—far exceeding the cost of ensuring compliance in the first place.
May 16, 2014
The California Department of Public Health has proposed to establish the first regulatory limit in the United States for hexavalent chromium (chromium-6) in drinking water. The proposed Maximum Contaminant Level (MCL) sets the limit for hexavalent chromium at 10 parts per billion. California, like those of other states and United States federal government, currently only regulates total chromium levels.
May 01, 2014
This article covers the changes so far to United States Pharmacopeia (USP) chapters and , the International Conference on Harmonisation (ICH), the European Medicines Agency (EMA), and the European Pharmacopoeia (EP), impending changes, and options for preparing for those changes.
April 01, 2009
In this column, Bob McDowall discusses the impact of USP general chapter 1058 on the spectroscopy laboratory.