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Focus on terms from the GxP division

Our glossary explains most of the terms used in the fields of GxP, qualification, validation and quality assurance. With the help of this compact reference work, we would like to provide everyone working in the field of GxP with a useful tool.


An audit is a systematic, independent and documented process for objectively obtaining and analysing audit evidence.

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Electronic forms

Electronic forms in a GxP environment Electronic forms play an essential role in the GxP environment. They make processes in regulated industries such as pharmaceuticals,

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Installation qualification

The installation qualification (IQ) checks that devices and systems are installed correctly in the GxP environment before commissioning. Installation qualification (IQ) is essential to the

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Process audit

Process audit in the GxP environment A process audit in the GxP environment refers to the systematic review of processes and procedures in regulated industries

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Site Master File

The Site Master File is a document that contains all relevant information on the manufacturing and quality control processes of a pharmaceutical site. The Site

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Software validation

Software validation in the GxP environment Software validation in the GxP environment confirms that software used in regulated industries such as pharmaceuticals, biotechnology, and medical

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Standard Operating Procedures

SOPs, kurz für Standard Operating Procedures, beschreiben detailliert die Abläufe von kritischen Vorgängen. Sie dienen dazu, die Qualität, Sicherheit und Effizienz dieser Prozesse zu gewährleisten und Compliance mit behördlichen Vorgaben sicherzustellen.

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