Spectroscopy - June 2009 - (Page 24) 24 Spectroscopy 24(6) June 2009 w w w. s p e c t r o s c o p y o n l i n e . c o m Table II: Modified software classification Modified Software Category Category 1: Infrastructure software Software Scope • Established or commercially available layered software including operating systems. • Infrastructure software tools. • Nonconfigurable instruments • Firmware calculations such as balances (with limited risk for changing results and data). • Standard functions of programmable firmware instruments (user-definted programs treated as category 5). • Nonconfigured commercial software applications. • Instruments controlled by nonconfigured software. • Instruments controlled by configurable software that is used unconfigured or with standard defaults. • Excel templates using basic arithmetic functions. • Configured products provide standard interfaces and functions that enable configuration of the application to meet user-specific business processes. • Configuration using a vendor-supplied language should be handled as custom components (category 5). • Complex Excel templates or statistical calculations. • Custom applications. • Custom modules written either in an established computer language or an internal scripting language that integrates with a commercial application. • Macros for use with a commercial application. • User-defined firmware programs. • Custom firmware • Spreadsheet visual basic for application (VBA) macros. Category 2: Firmware Category 3: Nonconfigured products Category 4: Configured products Category 5: Custom modules and applications Category 1: Greatly Expanded Scope — Infrastructure Software Category 1 has undergone a radical change and expansion from simply operating systems, that had been constant in GAMP versions 1 to 4, to infrastructure software. This category is broken down into two subcategories: Established or commercially available layered software and Infrastructure software tools. The intention is that the infrastructure software in this category provides the computing environment for running both regulated and nonregulated applications within an organization. All software in this category needs to be controlled and qualified in an organization so that dual standards are not applied by the IT department, which can question the status of validated applications if not done. Software in the subcategory of Established or Commercially Available Layered Software still includes operating systems from GAMP 4, but this has also been expanded to encompass a greater scope: databases programming languages middleware office software ladder logic interpreters (for manufacturing systems), statistical programming tools and spreadsheet packages. The key issue is that many of these software tools are the base products for the applications used in the laboratory or they are the foundation layer for the laboratory applications to operate under. For example, if your spectrometer has application software that has a database to manage the methods, data, and results you generate, the latter is configured by the spectrometer supplier from the outof-the-box database to operate with their application software. Languages are used as a means to write the applications, each of which will be validated for their intended use. Note that category 1 also includes office software such as word processing, spreadsheet, database, and presentation applications. Now before you rush off thinking that Excel templates and macros do not need to be validated, think again, as the guide notes that “applications developed using these packages” are excluded from category 1 and these can be category 3, 4, or 5, respectively (1), depending on their complexity. Note also the phrasing of the subcategory “established or commercially available”. This means that both open source and software commercial can be used, which ratifies the status quo (open source operating systems [Linux or OpenVMS], databases [MySQL], and source code management [SubVersion]). In many IT departments and research groups open source software is used and often this use can be extensive. Some people may argue that open source software is hacked code, but when the code can be reviewed by many programmers it may be argued that the quality of the finished application could be better than some commercially available software. Regardless of the debate, the word established allows the use of open source applications within category 1. The second subcategory is infrastructure software tools that comprise http://www.spectroscopyonline.com Table of Contents for the Digital Edition of Spectroscopy - June 2009 Spectroscopy - June 2009 Contents News Spectrum Auger Spectroscopy Statistics and Chemometrics for Clinical Data Reporting, Part 1 Understanding and Interpreting the New GAMP 5 Software Categories Current Status of Standoff LIBS Security Applications at the United States Army Research Laboratory Spectral Studies on the Interaction of [Ru(bpy)2(BTIP)]2+ with DNA and Determination of Nucleic Acids at Nanogram Levels Product Resources Calendar Ad Index Spectroscopy - June 2009 Spectroscopy - June 2009 - (Page BB1) Spectroscopy - June 2009 - (Page BB2) Spectroscopy - June 2009 - Spectroscopy - June 2009 (Page Cover1) Spectroscopy - June 2009 - Spectroscopy - June 2009 (Page Cover2) Spectroscopy - June 2009 - Spectroscopy - June 2009 (Page 3) Spectroscopy - June 2009 - Spectroscopy - June 2009 (Page 4) Spectroscopy - June 2009 - Spectroscopy - June 2009 (Page 5) Spectroscopy - June 2009 - Spectroscopy - June 2009 (Page 6) Spectroscopy - June 2009 - Spectroscopy - June 2009 (Page 7) Spectroscopy - June 2009 - Contents (Page 8) Spectroscopy - June 2009 - Contents (Page 9) Spectroscopy - June 2009 - Contents (Page 10) Spectroscopy - June 2009 - Contents (Page 11) Spectroscopy - June 2009 - News Spectrum (Page 12) Spectroscopy - June 2009 - News Spectrum (Page 13) Spectroscopy - June 2009 - Auger Spectroscopy (Page 14) Spectroscopy - June 2009 - Auger Spectroscopy (Page 15) Spectroscopy - June 2009 - Auger Spectroscopy (Page 16) Spectroscopy - June 2009 - Auger Spectroscopy (Page 17) Spectroscopy - June 2009 - Statistics and Chemometrics for Clinical Data Reporting, Part 1 (Page 18) Spectroscopy - June 2009 - Statistics and Chemometrics for Clinical Data Reporting, Part 1 (Page 19) Spectroscopy - June 2009 - Statistics and Chemometrics for Clinical Data Reporting, Part 1 (Page 20) Spectroscopy - June 2009 - Statistics and Chemometrics for Clinical Data Reporting, Part 1 (Page 21) Spectroscopy - June 2009 - Understanding and Interpreting the New GAMP 5 Software Categories (Page 22) Spectroscopy - June 2009 - Understanding and Interpreting the New GAMP 5 Software Categories (Page 23) Spectroscopy - June 2009 - Understanding and Interpreting the New GAMP 5 Software Categories (Page 24) Spectroscopy - June 2009 - Understanding and Interpreting the New GAMP 5 Software Categories (Page 25) Spectroscopy - June 2009 - Understanding and Interpreting the New GAMP 5 Software Categories (Page 26) Spectroscopy - June 2009 - Understanding and Interpreting the New GAMP 5 Software Categories (Page 27) Spectroscopy - June 2009 - Understanding and Interpreting the New GAMP 5 Software Categories (Page 28) Spectroscopy - June 2009 - Understanding and Interpreting the New GAMP 5 Software Categories (Page 29) Spectroscopy - June 2009 - Understanding and Interpreting the New GAMP 5 Software Categories (Page 30) Spectroscopy - June 2009 - Understanding and Interpreting the New GAMP 5 Software Categories (Page 31) Spectroscopy - June 2009 - Current Status of Standoff LIBS Security Applications at the United States Army Research Laboratory (Page 32) Spectroscopy - June 2009 - Current Status of Standoff LIBS Security Applications at the United States Army Research Laboratory (Page 33) Spectroscopy - June 2009 - Current Status of Standoff LIBS Security Applications at the United States Army Research Laboratory (Page 34) Spectroscopy - June 2009 - Current Status of Standoff LIBS Security Applications at the United States Army Research Laboratory (Page 35) Spectroscopy - June 2009 - Current Status of Standoff LIBS Security Applications at the United States Army Research Laboratory (Page 36) Spectroscopy - June 2009 - Current Status of Standoff LIBS Security Applications at the United States Army Research Laboratory (Page 37) Spectroscopy - June 2009 - Current Status of Standoff LIBS Security Applications at the United States Army Research Laboratory (Page 38) Spectroscopy - June 2009 - Spectral Studies on the Interaction of [Ru(bpy)2(BTIP)]2+ with DNA and Determination of Nucleic Acids at Nanogram Levels (Page 39) Spectroscopy - June 2009 - Spectral Studies on the Interaction of [Ru(bpy)2(BTIP)]2+ with DNA and Determination of Nucleic Acids at Nanogram Levels (Page 40) Spectroscopy - June 2009 - Spectral Studies on the Interaction of [Ru(bpy)2(BTIP)]2+ with DNA and Determination of Nucleic Acids at Nanogram Levels (Page 41) Spectroscopy - June 2009 - Spectral Studies on the Interaction of [Ru(bpy)2(BTIP)]2+ with DNA and Determination of Nucleic Acids at Nanogram Levels (Page 42) Spectroscopy - June 2009 - Spectral Studies on the Interaction of [Ru(bpy)2(BTIP)]2+ with DNA and Determination of Nucleic Acids at Nanogram Levels (Page 43) Spectroscopy - June 2009 - Spectral Studies on the Interaction of [Ru(bpy)2(BTIP)]2+ with DNA and Determination of Nucleic Acids at Nanogram Levels (Page 44) Spectroscopy - June 2009 - Product Resources (Page 45) Spectroscopy - June 2009 - Product Resources (Page 46) Spectroscopy - June 2009 - Product Resources (Page 47) Spectroscopy - June 2009 - Calendar (Page 48) Spectroscopy - 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