 | December 1, 2011
By:R.D. McDowall
Here's what needs to be done to harmonize these two documents.
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 | November 1, 2011
By:R.D. McDowall
Continued discussion of the periodic review process, including how to conduct a review, the use of checklists, and reporting the outcome
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 | September 1, 2011
By:R.D. McDowall
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.
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 | April 1, 2011
By:R.D. McDowall
The revisions to GMP Annex 11 are examined in terms of the impact on computerized spectrometry systems operating in regulated GMP laboratories.
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 | December 1, 2010
By:R.D. McDowall
Where is the dividing line between a simple mistake and falsification?
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 | September 1, 2010
By:R.D. McDowall
How good is documentation supplied by a vendor to support the qualification of an instrument or the validation of a laboratory computerized system?
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 | April 1, 2010
By:R.D. McDowall
Bob McDowall looks at the different life cycle models that apply in the laboratory to GAMP software categories 3, 4, and 5.
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 | December 1, 2009
By:R.D. McDowall
Getting the best business value from a spectrometer requires knowledge of the instrument and its operating abilities, any attachments, the sample including sampling procedure and presentation, and the software. All of these elements must be pulled together by a skilled and knowledgeable spectroscopist. Unfortunately, this is not always the case in many organizations.
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 | November 1, 2009
By:R.D. McDowall
The new FDA Commissioner wants a strong FDA and is backing her words with action by initiating a program that cuts the time that firms must respond to 483 observations from 30 to 15 business days. Not only is the time halved but the response must be complete. Therefore it is better and cheaper to be compliant than not.
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