Column: Focus on Quality

Nov 01, 2012
A look at how the term commercial off-the-shelf can be abused in marketing literature.
Sep 01, 2012
Guidelines for writing standard operating procedures in a laboratory and best practices for their use.
Apr 01, 2012
A discussion of the various options for cloud computing, avoiding the marketing hype and focusing on the potential advantages and disadvantages for your laboratory
Dec 01, 2011
Here's what needs to be done to harmonize these two documents.
Nov 01, 2011
Continued discussion of the periodic review process, including how to conduct a review, the use of checklists, and reporting the outcome
Sep 01, 2011
Annex 11 to the EU's updated GMP regulations calls for periodic re-evaluation of computerized systems. This is what you need to know about the new rules.
Apr 01, 2011
The revisions to GMP Annex 11 are examined in terms of the impact on computerized spectrometry systems operating in regulated GMP laboratories.
Dec 01, 2010
Where is the dividing line between a simple mistake and falsification?
Nov 01, 2010
It is just over two years since USP <1058> on Analytical Instrument Qualification (AIQ) became effective. To coincide with the American Association of Pharmaceutical Scientists (AAPS) Meeting in New Orleans this month where a roundtable discussion on the subject will be held, here are my views.
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