Understand and apply the current standards for IT validation
Learn how to manage the validation of IT systems and ensure data integrity and compliance. The course gives you the tools you need to understand the requirements, apply best practices, and strategically plan and execute IT validation.
Validation of IT systems refers to a process in which you examine and confirm that a given IT system meets specified requirements, functions as intended, and performs as expected.
The course provides you with an overview of current requirements and best practices for validation of IT systems. We review GAMP® 5, EudraLex Vol. 4 Annex 11, and 21 CFR Part 11 with a focus on validation, data integrity, and compliance. In addition, we discuss different validation approaches and how to strategically plan the validation using risk assessment and the validation master plan. In addition to legislation, we focus on the more operational part of validation. You will get tips on how to prepare IT systems specifications, carry out the validation, and ensure traceability between requirements and testing.
After the course, you will be ready to carry out a full IT system validation, apply your knowledge of legislation and the V-model as a validation strategy, and understand what is required to plan, execute and/or approve an IT validation. The course is a combination of presentations and workshops, where the topics are explored in greater depth.
The course language is English.
If all participants are Danish-speaking, the course will be conducted in Danish with English slides.
On this course, you will meet:
Marjun Jepsen, Validation Specialist, QV-Compliance A/S
