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In addition, private authors published reference books with practical recommendations for implementation:(3) has been recommended for users of commercial instruments without significant customization by the user.The V-model as recommended by GAMP4 (8) is suitable for software development as well as for users of commercial instruments with customization by the user.An agreement on terminology is of utmost importance for a common understanding of validation and qualification.The author has frequently noted at validation symposia that different speakers used different terms for the same thing and the same terms for different things.Because of the nature and size of this primer, all the details of operational qualification and system validation cannot be given.For more details, please refer to reference articles and text books (3-5).The word qualification relates to instruments that can be individual modules and also systems, for example, a complete HPLC system comprised of a sampling system, a pump, a column compartment and a detector.

Therefore, in the context of software and computer systems, this primer will also use the term validation.A major breakthrough came when USP released its general chapter on analytical instrument qualification (2).The major benefit of the chapter was that it formalized the 4Q model and clarified some issues that have been frequently discussed before, for example, that an instrument’s firmware does not need separate qualification, but should be qualified as part of the instrument hardware.Although the primer has recommendations for validation of standard commercial computerized analytical systems without the need for major customization, it does not give details on validation of complex systems, such as Laboratory Information Management Systems (LIMS), or on validation activities during software development but refers to further literature (7-11).Due to their importance, equipment qualification issues have been addressed by several organizations.Such specifications can only be verified with a complete system and accessories such as the right chromatographic column, calibration standards and SOPs for running the test.Unfortunately, validation and qualification are frequently used interchangeably.The word validation relates to applications, processes and methods.For example, for method validation we specify the limit of quantitation or limit of detection of our sample compounds.Qualification is done independently from a specific application or sample.Typically the type of specifications can be found in the vendor’s product specification sheet.

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