【分享】Validation of Spectrometry Software by R.D. McDowall

Part I
Feb 1, 2001
http://spectroscopyonline.findanalytichem.com/spectroscopy/data/articlestandard//spectroscopy/072003/46380/article.pdf

Part II: Roles of the Validation Plan and User Requirements Specification
http://www.rdmcdowall.com/Upload/39/7/40/0/2/0

Part III — Vendor Audit, System Purchase, and Preparation for Installation
Feb 2, 2002
http://spectroscopyonline.findanalytichem.com/spectroscopy/data/articlestandard//spectroscopy/052002/8466/article.pdf

Part IV — Qualification of the Software and System
Feb 1, 2003
http://spectroscopyonline.findanalytichem.com/spectroscopy/data/articlecolumn//spectroscopy/072003/46299/article.pdf

Part V —Performance Qualification
Apr 1, 2003
http://spectroscopyonline.findanalytichem.com/spectroscopy/data/articlecolumn//spectroscopy/142003/52620/article.pdf

Part VI — Designing Performance Qualification Tests
Jul 1, 2003
http://spectroscopyonline.findanalytichem.com/spectroscopy/data/articlecolumn//spectroscopy/272003/62315/article.pdf

Part VII – Training, System Documentation, and Writing the Validation Summary Report
Feb 1, 2004
http://spectroscopyonline.findanalytichem.com/spectroscopy/data/articlecolumn//spectroscopy/082004/86093/article.pdf

Part VIII of the series covers change control and its importance in maintaining a system’s validation status.
May 1, 2004
http://spectroscopyonline.findanalytichem.com/spectroscopy/data/articlecolumn//spectroscopy/192004/94290/article.pdf

Part IX of the series discusses backup and recovery, which are essential to the process of ensuring data security and integrity.
Sep 1, 2004
http://spectroscopyonline.findanalytichem.com/spectroscopy/data/articlecolumn//spectroscopy/402004/125365/article.pdf

Importance of Accurate Date and Time Stamps
Nov 1, 2005
http://spectroscopyonline.findanalytichem.com/spectroscopy/Focus+on+Quality+Column/Focus-on-Quality-mdash-Validation-of-Spectrometry-/ArticleStandard/Article/detail/197395

Critique of the GAMP Good Practice Guide for Validation of Laboratory Computerized Systems
Apr 1, 2006
http://spectroscopyonline.findanalytichem.com/spectroscopy/Focus+on+Quality+Column/Validation-of-Spectrometry-Software-Critique-of-th/ArticleStandard/Article/detail/318520

Risk Analysis Methodologies for Commercial Spectrometer Software
Jul 1, 2006
http://spectroscopyonline.findanalytichem.com/spectroscopy/Focus+on+Quality+Column/Validation-of-Spectrometry-Software-Risk-Analysis-/ArticleStandard/Article/detail/358671

A Suggested Integrated Approach to Equipment Qualification and Computerized System Validation
Nov 1, 2006
http://spectroscopyonline.findanalytichem.com/spectroscopy/Focus+on+Quality+Column/Validation-of-Spectrometry-Software-A-Suggested-In/ArticleStandard/Article/detail/387873

Applying an Integrated Approach to Equipment Qualification and Computerized System Validation
Dec 1, 2006
http://spectroscopyonline.findanalytichem.com/spectroscopy/Focus+on+Quality+Column/Validation-of-Spectrometry-Software-Applying-an-In/ArticleStandard/Article/detail/393888

Audit Trails for Spectrometer Software
Apr 1, 2007
http://spectroscopyonline.findanalytichem.com/spectroscopy/Focus+on+Quality+Column/Validation-of-Spectrometry-Software---Audit-Trails/ArticleStandard/Article/detail/421819

To Patch or Not To Patch - That Is the Question
Jul 1, 2007
http://spectroscopyonline.findanalytichem.com/spectroscopy/Calibration%2FValidation/Validation-of-Spectrometry-Software---To-Patch-or-/ArticleStandard/Article/detail/443481

Understanding the Role and Content of a Validation Master Plan
Jul 1, 2008
http://spectroscopyonline.findanalytichem.com/spectroscopy/Calibration%2FValidation/Validation-of-Spectrometry-Software-Understanding-/ArticleStandard/Article/detail/528886

The Proactive Use of a Traceability Matrix in Spectrometry Software Validation, Part I: Principles
Nov 1, 2008
http://spectroscopyonline.findanalytichem.com/spectroscopy/Calibration%2FValidation/Validation-of-Spectrometry-Software-The-Proactive-/ArticleStandard/Article/detail/564416

The Proactive Use of a Traceability Matrix in Spectrometry Software Validation, Part II: Practice
Dec 1, 2008
http://spectroscopyonline.findanalytichem.com/spectroscopy/Focus+on+Quality+Column/Validation-of-Spectrometry-Software-The-Proactive-/ArticleStandard/Article/detail/572066