Spectroscopy - June 2009 - (Page 23) w w w. s p e c t r o s c o p y o n l i n e . c o m June 2009 Spectroscopy 24(6) 23 Table I: Comparison of software categories in GAMP 4 and GAMP 5 GAMP 4 Software Categories Category 1: Operating Systems • Operating systems only GAMP 5 Software Categories Category 1: Infrastructure Software Greatly expanded scope to cover • Established or commercially available layered software including operating systems, databases, office applications, and so forth. • Infrastructure software tools including antivirus, network management tools, and so forth. Category 2: Firmware • Discontinued — firmware now treated as category 3, 4, or 5. • Clash with USP over approach for Group B laboratory instruments: validate or qualify? Category 3: Nonconfigured Products • Off-the-shelf products that cannot be changed to match the business processes. • Can also include products that are configurable but only the default configuration is used. Category 4: Configured Products • Configured products provide standard interfaces and functions that enable configuration of the application to meet user-specific business processes. • Configuration using a vendor-supplied scripting language should be handled as custom components (category 5). Category 5: Custom Applications • These applications are developed to meet the specific needs of the regulated company. • Implicitly includes internal application macros, LIMS language customizations, VBA spreadsheet macros. • High inherent risk with this type of software. Category 2: Firmware • Configurable and nonconfigurable firmware • Custom firmware is category 5 Category 3: Standard Software Packages • Commercially available standard software packages. • Configuration limited to establishing the run-time environment. Category 4: Configurable Software Packages • Configurable software packages provide standard interfaces and functions that enable configuration of user-specific business or manufacturing process. Category 5: Custom (Bespoke) Software • These systems are developed to meet the specific needs of the user company. Software Classification Categories As I mentioned earlier, the software categories in GAMP 5 have been revised (1). To appreciate the scope of these changes fully we need to look at the classification of software from GAMP 4 (2) and compare this with GAMP 5, as shown in Table I. In the beginning, or at least in GAMP 4, there were five categories of software: Category 1: Operating systems Category 2: Firmware Category 3: Standard software Category 4: Configured software Category 5: Custom software The constituents of each category are outlined in Table I; however, there was always a debate about some commercial software packages — were they category 3 or 4? Many spectroscopists would argue that an application should be classified as category 3 and not 4, as it should be less work to validate and evade the real classification. To help resolve this debate, in GAMP 5 the software categories have been revised and refined — most for the better and one for the worse. This is a natural evolution of this approach to software classification. So we now have the following four categories: Category 1: Infrastructure Software Category 3: Nonconfigured products Category 4: Configured products Category 5: Custom applications Refer to Table I as we discuss the changes in the software classification in more detail in the next section. Why Classify Software? Before we go into a detailed discussion of the software categories, perhaps we should ask the question “Why bother to classify software?”. What benefit does this software classification provide? If you look at Table I there is a built-in risk assessment. The least risky and most widely available software is in category 1 (operating systems, databases, office software, and other widely available software). This is widely available software that can be used by anyone and in any industry. As we progress through down the categories as shown in Table I, generally the software becomes more specialized in its function (from a general office application to software that can control a spectrometer to acquire and process data then report the results). As we go down the list there is the increasing ability of the users to change the operation of software and process the results until we reach category 5. In category 5 is a unique solution that is conceived, specified, written, tested, and maintained by the users or the organization; here is the greatest risk. Let’s now take a detailed look at each of the software categories and see what has changed and if there are any problems we need to discuss. Software Classification Changes and Their Laboratory Impact Presented and discussed here are the various changes to the software classifications in the new GAMP guide. 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 - June 2009 - Calendar (Page 49) Spectroscopy - June 2009 - Ad Index (Page 50) Spectroscopy - June 2009 - Ad Index (Page Cover3) Spectroscopy - June 2009 - Ad Index (Page Cover4) http://digital.findanalytichem.com/nxtbooks/advanstar/spectroscopy0810_bg http://digital.findanalytichem.com/nxtbooks/advanstar/spectroscopy0810_supp http://digital.findanalytichem.com/nxtbooks/advanstar/spectroscopy0710 http://digital.findanalytichem.com/nxtbooks/advanstar/spectroscopy0610 http://digital.findanalytichem.com/nxtbooks/advanstar/spectroscopy0510 http://digital.findanalytichem.com/nxtbooks/advanstar/spectroscopy0410 http://digital.findanalytichem.com/nxtbooks/advanstar/spectroscopy0310 http://digital.findanalytichem.com/nxtbooks/advanstar/spectroscopy0210 http://digital.findanalytichem.com/nxtbooks/advanstar/spectroscopy0110 http://digital.findanalytichem.com/nxtbooks/advanstar/spectroscopy1209 http://digital.findanalytichem.com/nxtbooks/advanstar/spectroscopy1109 http://digital.findanalytichem.com/nxtbooks/advanstar/spectroscopy1009 http://digital.findanalytichem.com/nxtbooks/advanstar/spectroscopy0909 http://digital.findanalytichem.com/nxtbooks/advanstar/spectroscopy0809 http://digital.findanalytichem.com/nxtbooks/advanstar/spectroscopy0709 http://digital.findanalytichem.com/nxtbooks/advanstar/spectroscopy0609 http://digital.findanalytichem.com/nxtbooks/advanstar/spectroscopy0509 http://www.nxtbook.com/nxtbooks/advanstar/spectroscopy0409 http://www.nxtbook.com/nxtbooks/advanstar/spectroscopy0309 http://www.nxtbook.com/nxtbooks/advanstar/spectroscopy0209 http://www.nxtbook.com/nxtbooks/advanstar/spectroscopy0109 http://www.nxtbook.com/nxtbooks/advanstar/spectroscopy1208 http://www.nxtbook.com/nxtbooks/advanstar/spectroscopy1108 http://www.nxtbook.com/nxtbooks/advanstar/spectroscopy1008 http://www.nxtbook.com/nxtbooks/advanstar/spectroscopy0908 http://www.nxtbook.com/nxtbooks/advanstar/spectroscopy0808 http://www.nxtbook.com/nxtbooks/advanstar/spectroscopy0708 http://www.nxtbook.com/nxtbooks/advanstar/spectroscopy0608 http://www.nxtbook.com/nxtbooks/advanstar/spectroscopy0508 http://www.nxtbook.com/nxtbooks/advanstar/spectroscopy0308 http://www.nxtbook.com/nxtbooks/advanstar/spectroscopy0208 http://www.nxtbook.com/nxtbooks/advanstar/spectroscopy0108 http://www.nxtbook.com/nxtbooks/advanstar/spectroscopy1207 http://www.nxtbook.com/nxtbooks/advanstar/spectroscopy1107 http://www.nxtbook.com/nxtbooks/advanstar/spectroscopy1007 http://www.nxtbook.com/nxtbooks/advanstar/spectroscopy0907 http://www.nxtbook.com/nxtbooks/advanstar/spectroscopy0807 http://www.nxtbook.com/nxtbooks/advanstar/spectroscopy0707 http://www.nxtbook.com/nxtbooks/advanstar/spectroscopy0607 http://www.nxtbook.com/nxtbooks/advanstar/spectroscopy0507 http://www.nxtbook.com/nxtbooks/advanstar/spectroscopy0407 http://www.nxtbook.com/nxtbooks/advanstar/spectroscopy0307 http://www.nxtbook.com/nxtbooks/advanstar/spectroscopy0207 http://www.nxtbook.com/nxtbooks/advanstar/spectroscopy0107 http://www.nxtbook.com/nxtbooks/advanstar/spectroscopy1106 http://www.nxtbook.com/nxtbooks/advanstar/spectroscopy0906 http://www.nxtbookMEDIA.com
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