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Give details of validating document

For example, for software and computer systems the term validation is always used, even though according to the previous definition qualification should be used.Therefore, in the context of software and computer systems, this primer will also use the term validation.

After an introduction to the chapter’s approach for instrument qualification, this primer will lead you through individual qualification phases and give recommendations for implementation.

The primer will not only help readers understand the instrument qualification process, but also offers templates and examples to easily implement qualification.

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.

There is a second aspect to why validation and qualification are important, and this is equally important for those working in a regulated and in an accredited environment.

Even though frequently not directly spelled out in regulations and official guidelines, such as Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP), or in quality standards, such as the International Organization for Standardization (ISO) Standard 17025, validation and qualification is usually required.

Exact procedures and test parameters very much depend on the type of instrument and applications.

Details on recommendations and services can be obtained from instrument vendors.

The FDA and other agencies do not really care what users call it, validation or qualification.

The inspector’s question will always be: how did you make sure that the data are accurate.

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