 | 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.
 |
 | 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.
|
 | 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.
|
 | June 1, 2009
By:R.D. McDowall
The GAMP (Good Automated Manufacturing Practice) guide version 5 was released in March 2008 and one of the changes was that the classification of software was revised — again. This column will look at what the changes mean for the laboratory and whether all of these should be implemented.
|
 | April 1, 2009
By:R.D. McDowall
In this column, Bob McDowall discusses the impact of USP general chapter 1058 on the spectroscopy laboratory.
|
 | December 1, 2008
By:R.D. McDowall
The second part of this column series on traceability matrices looks at some of the practical ways of tracing requirements from the user requirements throughout the life cycle documents.
|
 | November 1, 2008
By:R.D. McDowall
Tracing requirements from a user requirements specification throughout the life cycle is not only a very effective business tool to save time and effort in validation projects but also a regulatory expectation. This first installment of a two-part column series looks at the principles of a traceability matrix.
|
 | July 1, 2008
By:R.D. McDowall
Columnist Bob McDowall discusses the role of a validation master plan (VMP) for summarizing a laboratory's approach to computer validation.
|
 | April 1, 2008
By:R.D. McDowall
In this "Focus on Quality" column, we will look at the overall GMP changes and then ask the following question: Why has the laboratory not been included in the proposed changes?
|
| 
