GMP summarizes all measures that ensure consistently high quality in the production and storage of medicinal products.
An audit is a systematic and documented quality management examination procedure carried out by auditors.
GAMP 5 is the guideline for ensuring the quality and compliance of automated systems in the pharmaceutical industry.
Good Distribution Practice (GDP) refers to the requirements for the distribution chain of medicinal products and the measures used to control it.
Software validation checks that software meets the requirements and is suitable for the intended purpose.
Gxp stands for "Good Practices" and refers to a collection of guidelines to ensure quality and compliance in the life sciences.
Process validation provides documented proof that a process delivers predefined results and does not pose a risk.
A supplier evaluation is a systematic process that enables companies to assess suppliers based on defined criteria.
Computer system validation describes a documented process that consistently ensures that software does what it was designed to do.
This article shows you how to master challenges and stumbling blocks in the process validation of computer systems with confidence.