Computerised System Validation In Clinical Research
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Software is used widely in clinical trials: from managing worldwide trials to finding and scheduling patients, gathering trial data, and analyzing trial results. How is the quality of the computerized systems ensured? And how do we know the data generated by these systems is reliable and robust?
Validation of software ensures that clinical data generated by these systems is done in a structured way and ensures integrity, reliability, and robustness of the generated data.
In this 1-hour webinar, you will learn why computerized systems must go through a validation process when used in clinical trials, as well as the consequences of failing to validate your systems. We will explain the requirements for validation, who is responsible and when it is necessary. Through the speaker’s experience, you will learn the why, what, and how of validation with regards to regulatory requirements.
This webinar also provides you with a walk through the process of system validation and its key deliverables. And finally, you will be shown the way to either manage the validation process of your own system or make the right considerations when selecting software for your clinical trials.
Webinar takeaways for the audience
1. Understand for which software validation is required and in which regulations requirements for validation are documented
2. Understand who is responsible for validation and what the goal of validation is
3. Know what to look for when choosing software to be used in your clinical trial
4. Understand what steps should be taken to validate your (vendors’) system
5. Be aware of the challenges in the validation process and know how to ensure a smooth process
Presenter: Marieke Meulemans