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

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.

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

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

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

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,

In GxP organisations, this method refers to the formal and systematic process of demonstrating that specific processes, systems, equipment or procedures operate by applicable quality standards and regulations.

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

GMP – Good Manufacturing Practice – is an internationally recognised standard for the manufacture of medicinal products, medical devices and active ingredients. GMP aims to

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

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

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

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

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

Quality Management Representative in the GxP environment The Quality Management Representative in the GxP environment is critical in ensuring compliance with quality standards in industries

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

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

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

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.

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