Learn how to validate your ERP system in line with GAMP5 and discover insights tailored to regulated industries.
Find out how you can regulate audit trails & electronic signatures and comply with FDA 21 CFR Part 11.
GMP brings together all measures that ensure consistently high quality in the production and storage of medicinal products.
A quality audit is a systematic and documented assessment procedure from quality management, carried out by trained auditors.
GAMP 5 is the guideline for ensuring the quality and compliance of automated systems in the pharmaceutical industry.
An audit trail documents the correct execution of processes and strict compliance with all defined steps in a complete and electronic manner.
Yaveon explains what Good Distribution Practice (GDP) is, which requirements it sets, who is affected, and how certification works.
Software validation checks that software meets the requirements and is suitable for the intended purpose.
GxP stands for “Good Practices” – a set of guidelines designed to ensure quality and compliance in the life sciences industry.
Process validation provides documented proof that a process delivers predefined results and poses no risk.
A supplier evaluation is a systematic process that enables companies to assess suppliers based on defined criteria.
Computer system validation is a documented process that consistently ensures software does exactly what it was designed to do.
This article shows you how to navigate the challenges and pitfalls of computer system validation with confidence.