Audit
An audit is a systematic, independent and documented process for objectively obtaining and analysing audit evidence.
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.
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
And the aiti in the middle of it all!
A special reward for our successes!
We have released!
Our interim status of certification to the ISO 27001 standard
Every ball a success – our ball glass is back!
In keeping with this motto, we have a “Poet Soundsystem” in our shared space.
We currently support pharmaceutical, biotech, life science and chemical companies with software solutions and services that guarantee significantly greater efficiency and security without time-consuming customizing.