Jul 1, 2008
By:
R.D. McDowall
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Columnist Bob McDowall discusses the role of a validation master plan (VMP) for summarizing a laboratory's approach to computer validation.
Apr 1, 2008
By:
R.D. McDowall
|
U.S. Good Manufacturing Practice (GMP) regulations (21 CFR 211) have existed unchanged since 1978 (1), although in 1996 a draft amendment was issued but was never implemented (2). However, on December 4, 2007, the FDA issued a Direct Final Rule for 21 CFR 211 that will make changes to GMP for finished pharmaceuticals (3) effective in April 2008 as well as withdrawing the draft 1996 amendment (4). This is the first phase in changes that will be made by the FDA to update and harmonize the GMP regulations over the next few years. 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?
Dec 1, 2007
By:
R.D. McDowall
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Paper is easy to archive, but what about archiving electronic records? What do you do with all the electronic records that are generated? In this month's installment, columnist Bob McDowall explores the issue of electronic records management and looks at the recent guidance issued by the OECD for GLP laboratories.
Nov 1, 2007
By:
R.D. McDowall
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Using information provided by guidance documents from outside the spectroscopy laboratory can be very useful when trying to meet the regulations that we must follow.
Jul 1, 2007
By:
R.D. McDowall
|
Columnist Bob McDowall discusses operating system security patches.
Apr 1, 2007
By:
R.D. McDowall
|
Columnist Bob McDowall discusses the use of audit trails in the software applications used to control spectrometers that acquire, interpret, and report results from analyses. An effective audit trail is imperative to ensure the integrity of the data and the conclusions reached by the spectroscopist.
An integrated approach to the qualification of a near-infrared spectrometer combined with the validation of the controlling software is outlined in this column.
Dec 1, 2006
By:
R.D. McDowall
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December 2006. Columnist Bob McDowall takes an NIR spectrometer through the process outlined in his November column, in which he suggested an integrated approach to equipment qualification and computerized system validation for spectroscopy systems.
Nov 1, 2006
By:
R.D. McDowall
|
November 2006. Columnist Bob McDowall proposes an integrated approach to the combined issue of equipment qualification and computerized system validation for spectrometers that combines the qualification, day-to-day calibration, and maintenance of the instrument with the validation of the software for a system?s intended purpose.
Jul 1, 2006
By:
R.D. McDowall
|
A simplified risk analysis methodology is needed for the validation of commercial software used in the regulated laboratory. In this column, the author takes a look at two alternative approaches.
