EU Project

Segalstad Consulting—a part of EU Leonardo da Vinci Project

The EU Leonardo da Vinci project started in 2003 and ended in 2006. The project included about a dozen members at any time from two universities: Hogenschool Gent in Belgium and Escola Universitària Politèchnia De Mataró in Spain. Companies from Belgium and Spain were also involved in the project, while Siri Segalstad of Segalstad Consulting was the sole Norwegian collaborator.

The Creation of a Master’s Degree in IT Validation

The project’s goal was to create a complete Master’s Degree in IT Validation for the regulated industries. This included a complete curriculum: complete PowerPoint presentations for every lesson and tasks that the students were supposed to complete over the course of the semester. Everything had to be based on existing books and literature.

Siri Segalstad was in charge of creating four classes in IT Validation:
• Basic Quality Management System (QMS)
• Advanced Quality Management
• LIMS (Laboratory Information Management System)
Validation of IT Systems

It was expected that prospective students entered the class with some industry experience and a desire to learn more about the validation process. The classes were structured as web-based classes so that the teacher and the students could be located in different locales and still easily communicate.

The need for an IT Validation textbook

I quickly realized that there were no books that would cover what I wanted to cover in my classes. Books existed on QMS and validation according to pharmaceutical standards. A few books covered LIMS, but these were all more than ten years old and technology has changed a lot since then. Also, no books covered all the standards regardless of industry. Existing books covered either the pharmaceutical industry or not.

Thus I made the decision to write the textbook that I needed for my classes.

Where will the Master’s Degree in IT validation be taught?

No university has yet made the decision to offer the Master’s Degree in IT Validation. Apparently there is a lot of bureaucracy within the EU to accredit a new degree, and this takes time. Meanwhile some of the classes will be offered as parts of other degrees at Hogeschool Gent, provided enough students sign up, and Siri will teach her classes.