As continuous technology advancements, cloud computing, virtualized process control systems and manufacturing networks, including security, converge into a technology-driven, ever-adapting industry, so does the potential risk of non-compliance with both internal instructions as well as regulatory governance.
She has been performing computer system validations for large pharmaceutical companies and CROs for over 15 years.
When not working, she enjoys kayaking, reading, and gardening. Fontana is the proud mother of a son who is a college sophomore at UNC-Chapel Hill.
What is computer system validation and what regulations/guidelines require it?
Computer system validation (CSV) is documented evidence that a computer system does what it is intended to do.
In 2010, the European Union issued Annex 11, which stipulates the rules governing good manufacturing practice for using computer systems to develop medicinal products. In addition to the misconception mentioned above regarding Part 11 being the driver for computer system validation, here are some other misconceptions that I often hear customers mention: Want to get more information?