Spectroscopy - Focus on Quality Column
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Editor: R.D. McDowall, McDowall Consulting<br>
 Unique commentary on a range of topics
dealing with obtaining, handling, and reporting quality laboratory data. A must-read for spectroscopists in
pharmaceutical, environmental, or other regulated laboratories.2010-09-09T08:05:21ZUnderstanding and Interpreting the GAMP 5 Life Cycle Models for Software
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Bob McDowall looks at the different life cycle models that apply in the laboratory to GAMP software
categories 3, 4, and 5.2010-04-01T04:00:00Z
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http://spectroscopyonline.findanalytichem.com/spectroscopy/data/articlestandard/spectroscopy/162010/665761/1_focus_on_quality_flash_flash.jpgXMLAre You Getting Value from Your Spectrometer?
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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.2009-12-01T05:00:00Z
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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.2009-11-01T04:00:00Z
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http://spectroscopyonline.findanalytichem.com/spectroscopy/data/articlestandard/spectroscopy/492009/645432/1_focus_on_quality_flash_flash.jpgXMLUnderstanding and Interpreting the New GAMP 5 Software Categories
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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 &mdash; again. This column will look at
what the changes mean for the laboratory and whether all of these should be implemented.2009-06-01T04:00:00Z
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http://spectroscopyonline.findanalytichem.com/spectroscopy/data/articlestandard/spectroscopy/222009/600799/Bob-McDowall-flash_flash.jpgXMLUSP &lt;1058&gt; Analytical Instrument Qualification and the Laboratory Impact
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In this column, Bob McDowall discusses the impact of USP general chapter 1058 on the spectroscopy
laboratory.2009-04-01T04:00:00Z
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http://spectroscopyonline.findanalytichem.com/spectroscopy/data/articlestandard/spectroscopy/152009/592278/2_focus_on_quality_flash_flash.jpgXMLValidation of Spectrometry Software: The Proactive Use of a Traceability Matrix in Spectrometry Software
Validation, Part II: Practice
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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.2008-12-01T05:00:00Z
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Validation, Part I: Principles
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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.2008-11-01T04:00:00Z
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http://spectroscopyonline.findanalytichem.com/spectroscopy/data/articlestandard/spectroscopy/452008/564416/2_focus_on_quality_flash_flash.jpgXMLValidation of Spectrometry Software: Understanding the Role and Content of a Validation Master Plan
http://spectroscopyonline.findanalytichem.com/spectroscopy/Calibration%2FValidation/Validation-of-Spectrometry-Software-Understanding-/ArticleStandard/Article/detail/528886?contextCategoryId=2323&ref=25
Columnist Bob McDowall discusses the role of a validation master plan (VMP) for summarizing a
laboratory's approach to computer validation.2008-07-01T04:00:00Z
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http://spectroscopyonline.findanalytichem.com/spectroscopy/data/articlestandard/spectroscopy/282008/528886/1_focus_on_quality_flash_flash.jpgXMLUnderstanding the Implications of the 2008 GMP Update and Why the Laboratory Is Not Included
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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?2008-04-01T04:00:00Z
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http://spectroscopyonline.findanalytichem.com/spectroscopy/data/articlestandard/spectroscopy/142008/507429/2_focus_on_quality_flash_flash.jpgXMLElectronic Records Management
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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.2007-12-01T05:00:00Z
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http://spectroscopyonline.findanalytichem.com/spectroscopy/data/articlestandard/spectroscopy/512007/480209/2_focus_on_quality_flash_flash.jpgXMLUnderstanding the FDA's Current Thinking on Security and Access Control Requirements for Computerized
Systems
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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.2007-11-01T04:00:00Z
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http://spectroscopyonline.findanalytichem.com/spectroscopy/data/articlestandard/spectroscopy/482007/476138/1_focus_on_quality_flash_flash.jpgXMLValidation of Spectrometry Software - To Patch or Not To Patch - That Is the Question
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Columnist Bob McDowall discusses operating system security patches.2007-07-01T04:00:00Z
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http://spectroscopyonline.findanalytichem.com/spectroscopy/data/articlestandard/spectroscopy/302007/443481/1_focus_on_quality_flash_flash.jpgXMLValidation of Spectrometry Software - Audit Trails for Spectrometer Software
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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.2007-04-01T04:00:00Z
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Computerized System Validation
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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.2006-12-01T05:00:00Z
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Computerized System Validation
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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.2006-11-01T05:00:00Z
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Software
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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.2006-07-01T04:00:00Z
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Computerized Systems
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This month's "Focus on Quality" presents a critique of the GAMP Good Practice Guide.
And while columnist Bob McDowall finds much to recommend in the guide, he finds much more cause for
concern.2006-04-01T05:00:00Z
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Stamps
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Accurate and precise time and date stamps are critical to ensuring integrity of the data and results
generated by each computerized system used in any spectroscopy laboratory.2005-11-01T05:00:00ZXMLFocus on Quality: Validation of Spectrometry Software
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The author continues his discussion of the principles involved in the backup and recovery of
electronic records. This installment looks at the written procedures associated with this process for a
spectrometer operating in a regulated laboratory.2005-05-01T04:00:00ZXMLFocus on Quality: Validation of Spectrometry Software, Part IX (PDF)
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Part IX of the series discusses backup and recovery, which are essential to the process of ensuring
data security and integrity.2004-09-01T04:00:00ZPDFFocus on Quality
 Validation of Spectrometry Software, Part VIII (PDF)
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Part VIII of the series covers change control and its importance in maintaining a system's validation
status.2004-05-01T04:00:00ZPDFFocus on Quality
 Validation of Spectrometry Software, Part VII (PDF)
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This column discusses training and system documentation, and how to write a validation summary
report.2004-02-01T05:00:00ZPDFValidation of Spectrometry Software, Part VI: Designing Performance Qualification Tests (PDF)
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The author discusses how to identify some of the performance qualification tests to apply to
spectrometry software, how to write the test procedures and instructions, and how to execute 
 the actual
testing.2003-07-01T04:00:00ZPDFFocus on Quality: Validation of Spectrometry Software, Part V Â- Performance Qualification
(PDF)
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This installment of the ongoing series discusses performance qualification of software in regard to
system requirements.2003-04-01T05:00:00ZPDFFocus on Quality: Validation of Spectrometry Software, Part IV Â- Qualification of the Software and
System (pdf)
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An installment of the Focus on Quality column.2003-02-01T05:00:00ZPDFFocus on Quality: Validation of Spectrometry Software, Part III --- Vendor Audit, System Purchase, and
Preparation for Installation (PDF)
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Part three in the author's ongoing series about validating spectrometry software.2002-02-02T05:00:00ZPDFFocus on Quality: Validation of Spectrometry Software, Part I (PDF)
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Columnist R.D. McDowall discusses the process of validation of spectrometry software.2001-02-01T05:00:00ZPDF