Alan Loughlin

ALCOA+ is a set of principles that ensures data integrity in the life sciences sector. It was introduced by, and is still used by, the FDA – the US Food and Drug Administration. It has relevance in a range of areas, particularly in relation to pharmaceutical research, manufacturing, testing, and the supply chain. As well …

What is ALCOA+ and Why Is It Important to Validation and Data Integrity Read More »

Cloud infrastructure solutions, as well as Software as a Service (SaaS), Infrastructure as a Service (IaaS),

The FDA (US Food and Drug Administration) is due to release guidance on Computer Software Assurance. That guidance aims to put critical thinking at the centre of Computer System Validation (CSV) processes. In our latest infographic, we highlight the main differences between traditional CSV and the new Computer Software Assurace (CSA) approach.   Traditional CSV …

Infographic: Computer System Validation Vs. Computer Software Assurance Read More »