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Glossary

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.

Audit

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

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CAPA

CAPA stands for Corrective and Preventive Actions. It is an essential component of the quality management system in regulated companies in the life science sector.

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Complaint

A complaint in the healthcare sector refers to a customer or patient’s notification of dissatisfaction with a product or service. This can relate to a

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Deviation

Deviation in the quality management of pharmaceutical companies represents a discrepancy between the planned and actual conditions or results within a regulated process. Deviation and

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Document control

Document control refers to the process by which documents are created, reviewed, approved, distributed, amended and archived within an organisation. It ensures that documents are

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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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GAMP5

GAMP5, 2nd edition, is an update of the globally recognised guide for validating computerised systems in the pharmaceutical industry, published by the International Society for

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GxP

GxP stands for “Good x Practice” and comprises a series of quality guidelines and regulations, with the “x” representing different areas. GxP areas and fields

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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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ISO certification

ISO certification arose from the need to create international standards for quality management and assurance that companies worldwide can recognise and apply. The ISO (International

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Life Science

Life science is a broad field of science that focuses on the study of living organisms and their life processes. It includes a variety of

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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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Risk analysis

Risk analysis and risk assessment are crucial in the regulated life science industry to identify and minimize potential hazards for patients and consumers. Risk analysis

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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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Training management

In the GxP environment, training management refers to the systematic planning, organisation, and administration of training and further education for employees working in regulated areas

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